27.07.2023
To the attention of all interested stakeholders
Please be informed that the most recent update of the EU common list of COVID-19 antigen tests was published on 26.07.2023.
This list is available online:
https://health.ec.europa.eu/system/files/2023-07/covid-19_eu-common-list-antigen-tests_en.pdf
In the context of the COVID-19 pandemic, the Health Security Committee established in May 2021 a technical working group on COVID-19 diagnostic tests. This technical working group brought together experts from the 27 EU countries and Norway, as well as representatives from the Directorate-General for Health and Food Safety (DG SANTE), the Joint Research Centre (JRC) and the European Centre for Disease Prevention and Control (ECDC).
The aim of the technical working group was, in particular, to review the proposals put forward by EU countries as well as manufacturers for devices to be included in the EU common list of COVID-19 antigen tests.
In case the technical working group considered that an update of the EU common list of COVID-19 antigen tests was required, a proposal was presented to the Health Security Committee for formal agreement. Such updates concerned additions and/or removals of antigen tests, or updates regarding the availability of data and information (e.g. the publication of new validation studies). An addendum was published alongside every update of the EU common list, setting out further details and background information regarding the decisions taken by the technical working group.
This Annex is available online:
https://health.ec.europa.eu/system/files/2023-07/covid-19_eu-common-list-antigen-tests_addendum_en.pdf

24.07.2023
To the attention of manufacturers, authorised representatives, economic operators and all interested stakeholders
Please be informed that on 18 July 2023 the European Commission has published the Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, REV. 1.
The purpose of this Q & A Guideline is to facilitate the enforcement of Regulation (EU) 2023/607.
In Rev. 1 of the guideline, new questions were added and some questions from the initially published guideline were modified/supplemented.
The announcement is available online on the website of the European Commission:
https://health.ec.europa.eu/system/files/2023-07/mdr_proposal_extension-q-n-a.pdf
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20.07.2023
To the attention of interested persons
List of training providers with the topic of legislation in the field of medical devices, approved by the NAMMDR. In line with the Rules, in order to obtain an operating permit, the economic operator must have sufficient and qualified/trained staff for the activity carried out/the field in which he/she operates.
The Medical Device Regulatory Compliance Officer (PRCR) and Warehouse Manager must demonstrate attendance at medical device legislation training courses.
Articles 9 (3) of the Rules provides:
(3) The training courses will be carried out by authorised physical and legal persons whose object of activity is to provide the training provided for in paragraph (2) b) and who provide proof of professional experience in regulatory or conformity assessment activities related to medical devices, as follows:
a) in regulatory activities with professional experience of at least four years in the field of medical devices or participation in working groups specific to medical devices at European Commission/EU council level;
b) in medical device compliance assessment activities within a notified compliance assessment body on the specific medical device directives, for at least two years.
Since issuance of Order of the Minister of Health no. 566/2020, the NAMMDR has been so far in contact with the companies that issued diplomas/certificates as a result of organising training courses about the medical devices legislation and which we have found in the dossiers submitted by economic operators in order to approve the activity carried out. According to the internal work procedure, as specified in Art. 7 of the Rules, evidence of meeting the requirements of Art. 9 (3) by the employed lecturers have been required in order to teach these training courses.
Up to this date, the companies that have proven that they comply with these requirements are as follows:

When the list undergoes changes, we shall immediately post the revision. In this regard, please check the NAMMDR website regularly for updated information.
NOTE: The NAMMDR constantly monitors the activity of training providers. In this respect, if you are dissatisfied with the performance of the training providers regarding the manner in which the training is carried out or the quality of the provided services, you can report the negative aspects online at da@anm.ro or dgdm@anm.ro.

22.06.2023
To the attention of manufacturers, authorised representatives, economic operators and all stakeholders
Please be informed that Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council has been published.
The Regulation, together with Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications in accordance with Regulation (EU) 2017/745, for the products listed in Annex XVI, will be applicable from 22 June 2023.
As a consequence of the full applicability of the Common Specifications, starting from 22 June 2023, the MDR will also become applicable to products without a proposed medical purpose that are listed in Annex XVI to the Regulation.
Please find attached the notification of the European Commission:
https://eur-lex.europa.eu/legal-content/RO/TXT/HTML/?uri=CELEX:32023R1194&qid=1687344268439

19.05.2023
To the attention of manufacturers, authorised representatives, economic operators and all stakeholders
Please be advised that on 12 May 2023, the European Commission published the revision of document MDCG 2020-3 with guidance on the significant changes to the transitional provision in Article 120 of the MDR relating to devices covered by certificates, in line with the MDD or the AIMDD.
The changes made are as follows:
Section 4.1 – General provisions:
• Minor text change to clarify the fact that the changes made in order to comply with other Union legislation fall within the scope of the guidance only if the risk/benefit balance of the device is not adversely affected.
• Minor text change and introduction of a footnote regarding the validity of certificates during the transition period.
• Introduction of a footnote regarding statements listing insignificant changes for Class I devices.
Section 4.2 – Changes unrelated to design or intended purpose:
• Introduction of a footnote to rule out changing the legal manufacturer in the first example provided.
• Introduction of a final statement regarding the notification procedure agreed between the manufacturer and the notified body.
In section 4.3.2.3 – Design changes:
• Improved text in examples related to changes brought to device case and user interface layout, for more clarity.
• Inclusion of a note on the Benefit/Risk balance (in bold) in each subsection, for better reading and understanding.
The European Commission notification can be accessed at: https://health.ec.europa.eu/latest-updates/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en
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11.05.2023
To the attention of manufacturers, authorised representatives, economic operators and all stakeholders
Please be informed that on 10 May 2023, the European Commission posted the final draft of the Commission’s Implementing Regulation, amending the transitional provisions established in Regulation (EU) 2022/2346 laying down common specifications for the groups of products without an intended medical purpose, on the Commission’s website and is open for comments until 06.05.2023. Comments can be sent to the Commission.
This project is proposed for reasons of coherence and in order to provide legal certainty to economic operators by aligning the provisions relating to the transition periods in the Implementing Regulation R(EU) 2022/2346 for products covered by a certificate issued by a notified body according to Directive 93/42/EEC with those of Regulation R(EU) 2017/745, as amended by Regulation R(EU) 2023/607.
The notification of the European Commission is available online at: Amendment of common specifications for products without intended medical purpose listed in Ann. XVI – Reg. (EU) 2017/745 (europa.eu)
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31.03.2023
To the attention of economic operators who request the approval of the activity of installation and/or maintenance of medical gas distribution systems
As a result of Order no. 2412 of 15.09.2022 on approval of the technical “Regulation on hospital buildings – NP 015-2022″ issued by the Ministry for Development, Public Works and Administration and of the many requests for clarifications regarding the provisions of this Order, please read the following document.
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21.03.2023
To the attention of manufacturers of medical devices, in vitro diagnostic medical devices, authorised representatives, economic operators and all stakeholders
We hereby inform you that on 20 March 2023, the European Commission has published Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.
This Regulation is adopted following exceptional circumstances generated by an imminent risk of shortage of medical devices and the associated risk of a public health crisis.
Transitional provisions for medical devices
The certificates issued by notified bodies in accordance with the respective directives starting from 25 May 2017, which were still valid on 26 May 2021 and which expired before 20 March 2023, are considered valid until the dates specified in the table below only if one of the following conditions is met:
(a) prior to the date of expiry of the certificate, the manufacturer and a notified body have signed a written agreement for assessment of compliance related to the device covered by the expired certificate or related to a device intended to replace that device;
(b) a competent authority of a Member State has granted a derogation from the applicable compliance assessment procedure in accordance with Article 59(1) of Regulation 745/2017 or has requested the manufacturer, in accordance with Article 97(1) of Regulation 745 /2017, to carry out the applicable compliance assessment procedure.”;
Medical devices in the situation described above may be placed on the market or put into operation until the following dates:

Transitional provisions for in vitro diagnostic medical devices
Regulation (EU) 2017/746 is amended as follows:
1. Under Article 110, paragraph (4) is replaced by the following text:
„(4) Devices legally placed on the market in line with Directive 98/79/EC before 26 May 2022 and devices legally placed on the market after 26 May 2022 pursuant to paragraph (3) of this Article may still be placed on the market or put into service.”
2. Under Article 112, the second paragraph is replaced by the following text:
“As regards the devices referred to in Article 110 paragraphs (3) and (4) of this Regulation, Directive 98/79/EC shall continue to apply to the extent necessary for the application of the said paragraphs.”
The notification of the European Commission is available online here: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en#extension-of-the-transition-periods-provided-for-in-the-regulations
The European Commission has made available to interested parties a guideline on Questions and Answers on practical issues related to the implementation of Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices which can be downloaded from the European Commission’s website by accessing the following link:
https://health.ec.europa.eu/latest-updates/qa-practical-aspects-related-implementation-regulation-eu-2023607-extension-mdr-transitional-period-2023-03-28_en
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14.03.2023
To the attention of manufacturers of medical devices, in vitro diagnostic medical devices, authorised representatives, economic operators and all stakeholders
Please be informed that, on 08.03.2023, the European Commission has published the Commission Delegated Regulation (EU) 2023/502 of 1 December 2022 amending Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies and Commission Delegated Regulation (EU) 2023/503 of 1 December 2022 amending Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies, changing the deadlines for re-assessment of notified bodies from 3 to 5 years and setting the frequency of their subsequent complete re-assessment every 5 years.
These Regulations are available here:
Directives and regulations – Medical Devices

28.02.2023
To the attention of all economic operators
Please note that only manufacturers of medical devices outside the European Union are required to appoint a single authorised representative to introduce the device on the EU market.
In line with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, “authorised representative” means any physical or legal person established in the EU who has received and accepted a written mandate from a manufacturer outside the Union, to act on behalf of the manufacturer in relation to specified tasks regarding the latter’s obligations arising from this Regulation.
Only authorised representatives residing in Romania are required to register into the NAMMDR national database, when introducing the following types of medical devices on the market:
a) class I, IIa, IIb and III medical devices, including sterile and/or measuring devices;
b) systems and procedure sets covered by Article 22 of the Regulation;
c) active implantable medical devices.
Authorized representatives residing in other member states of the European Union shall NOT BE REGISTERED into the national database.
Moreover, free sale certificates are issued for export purposes only to authorised representatives residing in Romania.

15.02.2023
To the attention of manufacturers, authorised representatives, economic operators and all stakeholders
Please be informed that, starting from 13 February 2023, the Methodological rules for clinical evaluation and clinical investigations have entered into force by being published in the Official Gazette of Romania, Part I, No.120 bis/13.II.2023 of ORDER no. 330 of 13 February 2023 on clinical evaluation and clinical investigations with medical devices and for repeal of Order of the Minister of Health no. 792 of 29 June 2006 on conduct of the procedure for clinical investigation and the procedure for assessment of performance relating to medical devices.
This Order is available online under section Legislation/Medical devices/Orders of the Minister of health/2023.

14.02.2023
To the attention of manufacturers, notified bodies, healthcare institutions and all stakeholders in the field of in vitro diagnostic medical devices
We hereby inform you that, on 10 February 2023, the European Commission published the 2nd revision of the MDCG 2020-16 Guidance: Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR).
The changes brought with the 2nd revision of the guidance refer to minor changes to the examples, the addition of Annex 2 (diagram to help determine the classification of an IVD as CDx).
This guidance, regarding the application of Regulation (EU) 2017/746 for in vitro diagnostic medical devices addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarification on the classification rules set out in Annex VIII. This classification guidance also applies to companies providing informational or diagnostic services to EU patients or devices commissioned through distance selling.
The main purpose of this document is to provide guidance to manufacturers, notified bodies and healthcare institutions on how to classify an IVD before it is placed on the market, on how to make it available on the market or put it into service in the Union.
It is also intended to inform regulatory authorities and other interested parties when the assessment of the class assigned to an IVD is done by a manufacturer or a healthcare institution.
Therefore, and only upon request of a Member State, or on its own initiative, the Commission, after consulting the Medical Device Coordination Group (MDCG), decides, by means of implementing acts, on the application of Annex VIII to a particular device, or category or group of devices, in order to establish the classification of these devices (Article 47 (3-4) of the IVDR).
The European Commission announcement is available here: https://health.ec.europa.eu/latest-updates/update-mdcg-2020-16-rev2-guidance-classification-rules-vitro-diagnostic-medical-devices-under-2023-02-10_en
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13.01.2023
For the attention of healthcare professionals and researchers in healthcare institutions who intend to design, manufacture, modify and use in-house devices and all interested parties in the field of medical devices
Please be informed that, on 10 January 2023, the European Commission published the MDCG 2023-1 guidance: Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 intended for in vitro diagnostic medical devices (IVDR).
Medical devices can be manufactured and used within EU healthcare institutions (in-house devices), on a non-industrial scale, to meet the specific needs of target patient groups that cannot be met or cannot be met at the appropriate level of performance, by an equivalent CE marked device available on the market.
Medical devices manufactured and used only within healthcare institutions (in-house devices) are exempt from most of the provisions of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), provided that the healthcare institution complies with the conditions set out in Article 5 paragraph (5) of the Regulation.
In order to ensure the highest level of health protection, Article 5(5) lays down a number of rules concerning the manufacture and use of such in-house medical devices.
The provisions of Article 5(5) underlie the regulatory control and surveillance of in-house devices. This document provides guidance on the application of some of these rules.
Moreover, this guidance intends to encourage the harmonised application of Article 5(5) by national competent authorities.
Both Regulations also specify that any physical or legal person offering diagnostic or therapeutic services through distance sales to patients in the European Union must use devices which are compliant with the MDR or IVDR (Article 6 paragraph (2)). Please note that the provision for derogation from Article 5 paragraph (5) applies only to healthcare institutions in the EU.
While most of the recommendations in this document relate to both medical devices and in vitro diagnostic medical devices (IVDs), some are specific to IVDs; such cases are explicitly mentioned.
Regulation (EU) 2022/112 postponed the application of some, but not all, provisions for in-house IVDs. A schematic presentation of the moment of application of provisions of article 5 paragraph (5) of the IVDR can be found in Annex B to this guideline.
Please note that the corresponding Article 5(5) of the MDR is already fully applicable from 26 May 2021.
The European Commission announcement is available here: https://health.ec.europa.eu/system/files/2023-01/mdcg_2023-1_en.pdf
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23.12.2022
To the attention of manufacturers, authorised representatives, economic operators and all stakeholders
Please be informed that on 9 December 2022, the European Commission published the MDCG 2022-18 Guidance on application of Article 97 of the MDR related to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate.
„Legacy devices” are medical devices, active implantable medical devices and in vitro diagnostic medical devices covered by a valid EC certificate of compliance issued in accordance with Directive 93/42/EEC, Directive 90/385/EEC or Directive 98/79/EC and which continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).
In line with Article 94 of the MDR, if the assessment by the competent authorities of the member states of some medical devices, motivated either by the possibility of posing an unacceptable risk to the health or safety of patients, users or other persons, or which may affect public health or by non-compliance with another requirement of the MDR leads to finding the non-compliance of the medical device with certain requirements of the MDR (in this case, the lack of a valid EC certificate) but not to demonstrating unacceptable risks for the health or safety of patients, users or other persons, or which may affect public health, Article 97 of the MDR may apply.
The MDCG 2022-18 Guidance aims to achieve a common understanding of and a uniform approach to the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) in situations where a device is not in conformity with the MDR because its certificate issued under Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR.
The use of Article 97 MDR in those situations is meant to be a temporary solution. It will contribute to avoiding disruption of supply of devices on the EU market needed for health systems and patients.
It only applies to devices that are ‘in transition’ from the MDD or AIMDD to the MDR or, respectively, for which, despite reasonable efforts undertaken by the manufacturer to obtain certification under the MDR, the relevant conformity assessment procedure involving a notified body has not been concluded in time.
It does not apply to devices for which the certificate issued under the MDD or AIMDD has been suspended or withdrawn by the notified body; in other words, the Directive’s certificate must have been valid at the date of its expiry.
The announcement of the European Commission is available online at: https://health.ec.europa.eu/latest-updates/mdcg-position-paper-application-art97-mdr-legacy-devices-which-mddaimdd-certificate-expires-issuance-2022-12-09_en
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13.12.2022
To the attention of manufacturers, authorised representatives, economic operators and all stakeholders
Please be informed that Order no. 3539 of 24 November on approval of the Methodological rules for placement on the market of medical devices and registration of economic operators into the European database on medical devices (EUDAMED), as well as into the national database, and on waiver from compliance assessment procedures, was published in the Official Gazette of Romania No. 1180 of 9 December 2022.
This Order is available online under section Legislation/Medical devices/Orders of the Minister of health.
The request forms can be downloaded from Forms and tariffs – Medical Devices.

12.12.2022
To the attention of manufacturers of medical devices, in vitro diagnostic medical devices and all stakeholders
Please be informed that on 6 December 2022, the European Commission published the MDCG 2022-17 Guidance: MDCG (Medical Device Coordination Group) position paper on ‘hybrid audits’.
This paper outlines the Medical Device Coordination Group (MDCG) position on the possible use of hybrid audits by notified bodies under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
This paper aims to provide a definition for hybrid audits and clarifications with respect to how hybrid audits can be used under MDR and IVDR as advised following the publication of MDCG 2022-143. Certain conformity assessment procedures under the MDR and the IVDR require the notified body to carry out audits of the manufacturer’s quality management system (QMS).
The assessment procedure must include an audit on the manufacturer’s premises both for the initial assessment and for the periodic surveillance. The same requirement applies, as appropriate, for audits to occur on the premises of the manufacturer’s suppliers and/or subcontractors. In addition to the terms ‘premises’ or ‘on the premises’, also ‘on-site’ and ‘off-site’ are used in the MDR and the IVDR to describe where conformity assessment activities take place.
To clarify the meaning of the term ‘hybrid audit’, the MDCG agrees on the following definition.
A ‘hybrid audit’ should be understood as an audit on the premises of the manufacturer or its supplier(s) and/or subcontractor(s) with at least one auditor present on the premises and other members of the audit team participating from elsewhere using information and communication technologies (ICT).
The announcement of the European Commission is available online at: https://health.ec.europa.eu/latest-updates/mdcg-2022-17-mdcg-position-paper-hybrid-audits-december-2022-2022-12-06_en
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06.12.2022
To the attention of manufacturers, authorised representatives, economic operators and all stakeholders
We hereby inform you that on 1 December 2022, Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices was published in the Official Journal.
Regulation (EU) 2017/745 lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. Regulation (EU) 2017/745 further requires the Commission to adopt for groups of products without an intended medical purpose listed in its Annex XVI, common specifications addressing, at least, application of risk management as set out in the general safety and performance requirements laid down in Annex I to that Regulation and, where necessary, clinical evaluation regarding safety.
Classification rules 9 and 10 on active devices in sections 6.1. and 6.2. of Annex VIII to Regulation (EU) 2017/745 refers to an intended medical purpose, namely for therapy and diagnosis, and therefore cannot be applied to active products without an intended medical purpose, referred to in Article 1 paragraph (2) of this Regulation. Therefore, such products must be classified in class I in accordance with rule 13 of section 6.5. of Annex VIII to Regulation (EU) 2017/745.
The announcement of the European Commission is available online at: EUR-Lex – 32022R2346 – EN – EUR-Lex (europa.eu) și EUR-Lex – 32022R2347 – EN – EUR-Lex (europa.eu).
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06.12.2022
To the attention of in vitro diagnostics laboratories in Romania and all stakeholders
Please be advised that on 30 November 2022, the European Commission published a set of information containing information intended for candidates for the designation of EU reference laboratories.
This set of information aims to summarize key information in an accessible manner, subject to change. Please consult the relevant legislation and the text of the call for applications for full details and/or contact the NAMMDR for further information.
The announcement of the European Commission is available online at: https://health.ec.europa.eu/latest-updates/updated-information-pack-candidate-eu-reference-laboratories-published-2022-11-30_en
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23.11.2022
To the attention of economic operators and all stakeholders
Please be informed that, starting from 22 November 2022, the new tariffs applied for the services provided by the NAMMDR have entered into force by publication in the Official Gazette of Romania, Part I, No.1123/22.XI.2022 of ORDER No. 3467 of 17 November 2022 on approval of the tariffs for the activities carried out by the National Agency for Medicines and Medical Devices of Romania (NAMMDR) in the field of medical devices.
You can access this Order under section Medical devices/ Legislation – Medical devices/Orders of the Minister of Health/2022 – link:
https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
Payment forms can be downloaded from section Forms and tariffs – Medical devices:
https://www.anm.ro/en/dispozitive-medicale/formulare-si-tarife/

07.11.2022
To the attention of authorised representatives, manufacturers, economic operators and all stakeholders
Please be informed that on 31 October 2022, the European Commission published the MDCG 2022-16 Guidance: Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
This guidance document is written for authorised representatives, manufacturers and other economic operators, and intends to provide guidance on relevant requirements under the two Regulations.
Where clarification is already covered by other MDCG guidances, this guidance on authorised representatives includes a reference.
The requirement to have an authorised representative is not applicable to devices intended for clinical investigation (MDR) or performance study (IVDR).
To this end, Article 62(2) MDR and Article 58(4) IVDR state that ‘where the sponsor of a clinical investigation or performance study is not established in the Union, that sponsor shall ensure that a natural or legal person is established in the Union as its legal representative’
As the legal representative is not defined as the authorised representative, these requirements are not further included in this guidance.
The announcement of the European Commission is available online at: https://health.ec.europa.eu/latest-updates/mdcg-2022-16-guidance-authorised-representatives-regulation-eu-2017745-and-regulation-eu-2017746-2022-10-31_en
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31.10.2022
To the attention of manufacturers of in vitro diagnostic medical devices, economic operators, notified bodies and all stakeholders
Please be informed that on 04.07.2022, the European Commission published the Regulation (EU) 2022/1107 of 4 July 2022 laying down common specifications in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council.
In case of some class D in vitro diagnostic medical devices D falling under the scope of Regulation (EU) 2017/746, there are no harmonised standards as regards some requirements of Annex I to the respective Regulation and it was necessary to address public health concerns, since the risk associated with the use of the respective medical devices is vital for public health and patient safety. Thus, common specifications have been adopted for the concerned devices, as regards the respective requests.
This Regulation is available online:
https://eur-lex.europa.eu/legal-content/RO/TXT/PDF/?uri=CELEX:32022R1107&from=EN.

14.10.2022
To the attention of medical devices manufacturers and all stakeholders
On 13.10.2022, Emergency ordinance regarding the setup of an institutional framework, as well as the necessary measures, in order to ensure direct application of the provisions of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU, was published in the Official Gazette of Romania, Part I, no. 995
The ordinance is available online, under section Medical Devices Legislation – Laws, ordinances and government decisions – 2022

10.10.2022
To the attention of manufacturers of custom-made devices, based in Romania
Please be informed that Order No. 2845 of 29 September 2022 on approval of the Methodological norms for approval of provisions of Article 13 of Emergency Government Ordinance no. 46/2021 on the establishment of the institutional framework and the measures necessary to ensure the direct application of the provisions of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) no. 178/2002 and Regulation (EC) no. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, on registration of custom-made devices placed on the market under their own name by manufacturers based in Romania was published in the Official Gazette of Romania No. 977 of 7 October 2022.
This Order is available online under section Legislation/Medical devices/Orders of the Minister of health.
The request form can be downloaded from Forms and tariffs – Medical Devices.

19.09.2022
To the attention of manufacturers of in vitro diagnostic medical devices, economic operators, notified bodies and all stakeholders
Please be informed that on 14 September 2022, the European Commission published the MDCG 2022-15 Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD.
This document provides information related to Article 110 (2) and Article 110 (3) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) states that medical devices covered by valid certificates issued by a body notified in line with Directive 98/79/CE on in vitro diagnostic medical devices – IVDD can be marketed or commissioned after date of enforcement of the IVDR, no later than 26 May 2025, in some cases.
The abovementioned conditions require that the notified body which has issued the certificate in line with the IVDD continues to carry out appropriate supervision regarding the applicability of the requirements related to the devices it has certified. It is thus important for manufacturers, notified bodies and national authorities to be clear about the activities taking part in the appropriate surveillance referred to in Article 110(3) of the IVDR.
To properly address the application of transitional provisions to medical devices covered by certificates issued in line with the IVDD, this guideline, issued in accordance with MDCG 2022-4 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR (https://health.ec.europa.eu/latest-updates/mdcg-2022-4-guidance-appropriate-surveillance-regarding-transitional-provisions-under-article-120-2022-02-16_en) and MDCG 2022-8 Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 (https://health.ec.europa.eu/latest-updates/mdcg-2022-8-regulation-eu-2017746-application-ivdr-requirements-legacy-devices-and-devices-placed-2022-05-20_en), should be read in conjunction with MDCG 2022-6 – Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR (https://health.ec.europa.eu/latest-updates/mdcg-2022-6-guidance-significant-changes-regarding-transitional-provision-under-article-1103-ivdr-2022-05-04_en).
For the purpose of this document, „legacy devices” should be understood as devices which, in line with Article 110 (3) of the IVDR, are placed on the market following enforcement of the IVDR (26 May 2022) and until the end of the respective transition period mentioned in Article 110 (3) – the 2nd or 3rd paragraph, if certain conditions are met.
Only devices covered by a valid CE certificate, issued in accordance with the IVDD prior to 26 May 2022, are covered in this guide.
The notification of the European Commission is available online: https://health.ec.europa.eu/system/files/2022-09/mdcg_2022-15_en.pdf.

19.09.2022
To the attention of manufacturers of in vitro diagnostic medical devices, economic operators, notified bodies and all stakeholders
Please be informed that, on 14 September 2022, the European Commission published the MDCG 2021-22 Rev.1 – Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert group referred to in Article 48(6) of Regulation (EU) 2017/746.
This document provides information on Class D devices, Article 48(6) of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) – sets out the conditions to be applied by the notified body in order to determine whether the expert group must be consulted on the manufacturer’s performance assessment report.
These conditions are: (1) the absence of common specifications for the Class D device in question;
(2) where is the first certification for that specific type of device.
This guideline provides clarification on the meaning of these conditions and the corresponding procedures to be followed by the notified body.
The notification of the European Commission is available online: https://health.ec.europa.eu/system/files/2022-09/mdcg_2021-22_en.pdf.

14.09.2022
To the attention of interested persons
To the attention of economic operators (OE) requesting approval for importing medical devices, in line with Article 2 a) of the Methodological Norms for application of Title XX of Law no. 95/2006 on healthcare reform, regarding the approval of activities in the field of medical devices (MD), approved through Order of the Minister of Health no. 566/2020 (Norms).
download document…

13.09.2022
To the attention of all interested persons (users, distributors etc.)
The National Agency of Medicines and Medical Devices in Romania warns all users of benzocaine-containing local anaesthetic TOPIGEL, manufactured by LABORATORIOS CLARBEN, SA, Spain, wrongly classified as medical devices (class I), to immediately stop using it and return the products to the distributors from whom they purchased them and to report each their own situation to the National Agency for Medicines and Medical Devices of Romania – Marketing Surveillance Service.
The National Agency for Medicines and Medical Devices of Romania warns all distributors of benzocaine-based local anaesthetic, TOPIGEL, manufactured by LABORATORIOS CLARBEN, SA, Spain to immediately stop making this product available on the Romanian market, to notify the National Agency of Medicines and Medical Devices of Romania regarding the stock held and the suppliers from whom they obtained these products.

09.09.2022
To the attention of interested persons
The legal consequences of refusing or delaying an unexpected inspection
As a market surveillance authority, the NAMMDR acts in the interest of economic operators, end users and user specialist staff in order to ensure that the public interests falling under the relevant Union harmonisation legislation for medical devices are permanently maintained and protected by measures ensuring that the appropriate legislation is applied, and that compliance with this legislation is ensured throughout the supply chain through appropriate controls.
In this capacity, the NAMMDR has the right to carry out on-site inspections and physical checks of products without prior notification, the right to enter any premises, any area or any means of transportation that the economic operator in question uses for purposes related to its commercial, business or professional activity, to identify non-compliance and obtain evidence (Article 14 paragraph (4) of Regulation (EU) 2019/1020 on market surveillance and product compliance, amending Directive 2004/42/EC and Regulations (EC) No. 765/2008 and (EU) No. 305/2011).
Article 93 of Regulation 2017/745 on medical devices stipulates that the competent authority carries out both announced inspections and, if required, unannounced inspections at the premises of economic operators as well as at the premises of suppliers and/or subcontractors and, where necessary, at the units of professional users.
Moreover, it is established through Article 928 of Law 95/2006, republished, that medical devices commissioned and in use are subject to the following control methods: unannounced inspection and testing, in-use surveillance.
Article 8 of Decision no. 306 of 23 March 2011 on measures for the surveillance of the market for products under European Union regulation for harmonised marketing stipulates that surveillance of products placed on the market and/or commissioned is carried out also by unannounced controls and point checks.
Given the above, please be informed that unlawfully obstructing, in any form, the authorised persons to perform their duties mentioned in this title, represents an infringement and is fined from 5,000 to 10,000 lei, in line with Article 935 paragraph 1) point g) of Law 95/2006 republished.
Article 18 of Government Ordinance 2/2001 on the legal regime of contraventions stipulates that in case of refusal, in order to identify the perpetrator, the official examiner can contact the police, gendarmes or local police. (“Article 18. The perpetrator is obliged to present to the official examiner, upon request, the identity document or the documents on the basis of which the mentions provided for in Article 16 paragraphs (1) and (11) are made. In case of refusal, in order to identify the perpetrator, the official examiner can contact the police, gendarmes or local policemen.”)
Through checks carried out and removal of non-compliant medical devices, we aim to ensure a high level of protection of patient and user health and safety, these actions targeting the general public interest.

08.09.2022
To the attention of legal representatives and persons responsible for medical devices within hospitals
As a market surveillance authority, the NAMMDR acts in the interest of economic operators, end users and user specialist staff in order to ensure that the public interests falling under the relevant Union harmonization legislation for medical devices are permanently maintained and protected by measures ensuring that the appropriate legislation is applied, and that compliance with this legislation is ensured throughout the supply chain through appropriate controls. In this capacity, the NAMMDR has the right to carry out on-site inspections and physical checks of products without prior notification, the right to enter any premises, any area or any means of transportation that the economic operator in question uses for purposes related to its commercial, business or professional activity, to identify non-compliance and obtain evidence (Article 14 paragraph (4) of Regulation (EU) 2019/1020 on market surveillance and product compliance, amending Directive 2004/42/EC and Regulations (EC) No. 765/2008 and (EU) No. 305/2011).
Article 93 of Regulation 2017/745 on medical devices stipulates that the competent authority carries out both announced inspections and, if required, unannounced inspections at the premises of economic operators as well as at the premises of suppliers and/or subcontractors and, where necessary, at the units of professional users.
Please be informed that during the following period, as part of the market surveillance activity and the control topics established at NAMMDR/DGDM/DRSP level, controls will be carried out in hospital units, aiming to assess compliance with the legal provisions in force in the field of medical devices in use.
Within the respective controls, the following aspects will be checked first and foremost:
– whether a person responsible for maintaining records of medical devices in use and acting as a contact person in the relationship with the NAMMDR is appointed;
– whether a register of medical devices in use is established according to the methodological norms in force;
– whether the installation, maintenance and repair of medical devices is ensured with the help of units specialised in performing such services;
– whether the periodic verification of the used medical devices is ensured, according to legal provisions;
– whether the medical devices are used only during their shelf life, when applicable, and when they do not present deviations from the functional performances and from the applicable security requirements;
– whether optimal conditions for keeping and storing medical devices are ensured, according to the requirements specified by the manufacturer;
– whether the label and instructions for use of the medical devices/medical device accessories and consumables in use/storage comply with the requirements set out in Annex I chapter III point 23 of Regulation (EU) 2017/745, respectively the requirements set out in Annex I chapter III point 20 of Regulation (EU) 2017/746 in the case of medical devices for in vitro diagnosis.
The following link: https://www.anm.ro/dispozitive-medicale/supraveghere-in-utilizare/
highlights a part of the legal obligations of professional users of medical devices.
The legislation considered within the control topics is the following:
– Law No. 95 Republished*) of 14 April 2006 on healthcare reform – Title XX
*) It includes all the changes made to the official document published in the Official Gazette, including those provided in: Government Ordinance No. 37/31.08.2022 Published in the Official Gazette no. 857/31.08.2022
This Law is available online:
(https://www.anm.ro/_/DM/LEGISLATIE/legea%2095_titlul%20XX_05.09.2022.pdf)
– ORDER No. 2219 of 14 July 2022 regarding the control through periodic verification of the medical devices in use, the evaluation of the performances of the second-hand medical devices put into operation and the issuance of an approval for use of the medical devices as equipment of healthcare units and of means of intervention for pre-hospital emergency medical assistance;
The Order is available online:
(https://www.anm.ro/_/DM/LEGISLATIE/15.2.%20ORDIN%202219%20DIN%2014%20IULIE%202022.pdf )
– Order of the minister of health no. 2882/2021 on how to report suspected serious incidents related to medical devices;
The Order is available online:
(https://www.anm.ro/_/DM/Ordin%202882-2021.pdf )
– Order no. 566/2020 for approval of the Methodological Norms for application of Title XX of Law no. 95/2006 on healthcare reform, regarding the approval of activities in the field of medical devices;
The Order is available online:
(https://www.anm.ro/_/DM/Ordinul%20nr.%20566%20si%20Anexe.pdf )
– REGULATION (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. This Regulation is available online:
(https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20200424&qid=1651491231964 )
– EMERGENCY ORDINANCE no. 46 of 9 June 2021 on establishment of an institutional framework and measures for enforcement of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC;
This Ordinance is available online:
(https://legislatie.just.ro/Public/DetaliiDocument/243191)
– Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
This Regulation is available online:
(https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20220128&qid=1651491186034)
Through the checks carried out and removal of non-compliant medical devices, we aim to ensure a high level of protection of patients’ and users’ health and safety, these actions targeting the general public interest.

30.08.2022
To the attention of all persons interested in the issuance of a waiver from assessment of compliance procedures
On the basis of a justified request, the NAMMDR authorises the placement on the market or commissioning on the territory of Romania of a certain device for which the compliance assessment procedures have not been carried out, but whose use is in the interest of public health or patient health, in line with provisions of Article 59 of Regulation (EU) 2017/745 on medical devices.
This national waiver applies for a limited period (the period considered reasonable for completion of the compliance assessment procedure or the necessity in use of the medical devices subject to national waiver), only in exceptional, well-justified cases, when there is no similar product on the market, when the manufacturer demonstrates that he has started the compliance assessment procedures or, as the case may be, that he has been prevented from completing/initiating these procedures by exceptional and unforeseeable circumstances.
In order to obtain the waiver, the applicant submits to the NAMMDR an application accompanied by documents justifying the fact that the product is safe to use (declaration of compliance issued by the manufacturer, certificate of compliance issued by a notified body (as applicable), technical specification, label, instructions for use, evidence regarding the lack of complaints/incidents, evidence regarding the steps taken in view of certification, other certificates/approvals/authorisations obtained) as well as evidence regarding the need for the respective medical device on the market (lack of a substitute and the need to cover the respective segment).
To solve the request, the NAMMDR may additionally request documents provided for in the legislation applicable to the type of medical device.

30.08.2022
To the attention of interested persons
Guideline on the ability of notified bodies and the availability of medical devices
Please be informed that on 26 August 2022, the Medical Devices Coordination Group (MDCG) of the European Commission has issued an opinion document, MDCG 2022-14 ”Transition to the MDR and IVDR. Notified body capacity and availability of medical devices and IVDs”, available online: https://health.ec.europa.eu/latest-updates/mdcg-2022-14-transition-mdr-and-ivdr-notified-body-capacity-and-availability-medical-devices-and-2022-08-26_en.

16.08.2022
To the attention of all parties interested in devices without an intended medical purpose
Please be advised that the final draft of the Implementing Regulation on reclassification of the groups of active products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, was posted on the European Commission website, DG SANTE: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12972-Medical-devices-reclassification-of-products-without-an-intended-medical-purpose_en
All those interested may send comments until 8 September 2022.

25.07.2022
To the attention of in vitro diagnostics laboratories in Romania and all interested parties
The European Commission Directorate-General for Health and Food Safety (DG SANTE) officially launches a call for applications for the designation of EU reference laboratories in the field of in vitro diagnostic medical devices, in line with Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
In accordance with Article 100(1) of Regulation (EU) 2017/746, applications can only be submitted by Member States through the competent authority.
Laboratories intending to register in order to be designated as an EU Reference Laboratory must strictly comply with several requirements and application deadlines.
Member States are requested to submit registration applications for designation by 31 March 2023, 12:00 CET. The deadline cannot be extended and any application submitted after this deadline will not be considered.
In order to meet this deadline, it is recommended that candidate laboratories submit their applications to their Member States by 12:00 CET on 5 January 2023.
The tasks and criteria that must be fulfilled by reference laboratories of the European Union in the field of in vitro diagnostic medical devices for can be found in the Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices.
This Regulation, as well as more information, are available online:
https://health.ec.europa.eu/latest-updates/setting-scene-eu-reference-labs-high-risk-diagnostics-2022-06-21_en
Those interested are invited to contact the National Agency for Medicines and Medical Devices of Romania in order to obtain all the necessary information in order to register their candidacies at: dgdm@anm.ro.

04.07.2022
To the attention of laboratories in the field of in vitro diagnostics in Romania and all interested parties
Please be advised that two implementing acts related to the application of Regulation (EU) 2017/746 were published on 22.06.2022 in the Official Journal of the European Union, namely:
Commission Implementing Regulation (EU) 2022/944 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices
Commission Implementing Regulation (EU) 2022/945 of 17 June 2022 laying down rules for the application of Regulation (EU) 2017/746 of the European Parliament and the Council with regard to fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices
These refer to the requirements which must be met by laboratories in order to be recognized as EU reference laboratories, their duties and the tariffs which they will charge when carrying out specific activities.
The evaluation and designation of these laboratories will be done by the European Commission, with the collaboration of the Joint Research Center (JRC), based on the proposals of national authorities.
The NAMMDR, as the responsible national authority, receives requests from laboratories in Romania which intend to become reference laboratories, in view of a preliminary evaluation.
Requests for information can be sent via e-mail: dgdm@anm.ro. The regulations are posted under the “Medical devices – European regulations on medical devices” section.

31.05.2022
To the attention of manufacturers of medical devices and/or in vitro diagnostic medical devices in Romania and all interested parties
Please see the list of harmonised standards for medical devices and in vitro diagnostic medical devices under the Medical devices – European regulations on medical devices section.

11.05.2022
To the attention of interested persons
The NAMMDR would like to inform you about the 9th Romanian Pharmacovigilance Workshop which will be held in Bucharest, between 2-4 November 2022.
The topics: EudraVigilance news, Signal detection, PASS, PAES, Advanced therapy medicinal products, inspections and audits, SPOR and more… , presented in English by Dr. Calin A. Lungu.
Detalied information are available in the Agenda.
* Due to possible travel or meeting restrictions that might be in place, this workshop may be held online with the same agenda.

02.03.2022
To the attention of manufacturers of in vitro diagnostic medical devices in Romania and all interested parties
We inform you that a public consultation has been launched on the European Commission’s website regarding the Draft Implementing Regulation and its Annex on common specifications for certain Class D medical devices according to Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). The deadline for submitting comments is 9 March 2022.
This document is available online: In vitro diagnostic medical devices – common specifications (europa.eu)

21.02.2022
To the attention of manufacturers of in vitro diagnostic medical devices in Romania and all interested parties
REGULATION (EU) 2022/112 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices
Please be informed that on 28 January 2022, the Official Journal of the European Union published Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices.
Regulation (EU) 2022/112, leaving unchanged the IVDR application date of 26 May 2022:
– provides that devices legally placed on the market through a certificate issued by a notified body in accordance with the current Directive on in vitro diagnostic medical devices (Directive 98/79/EC; IVDD) before 26 May 2022 may continue to be placed on the market or commissioned by 26 May 2025.
– introduces adapted transition periods for devices which are to be subject to a compliance assessment involving bodies notified under the Regulation (IVDR) for the first time, but which have a Declaration of Compliance issued in line with Directive (IVDD) before 26 May 2022. The length of the transition period depends on the risk class of the device in question. Lower risk devices (class B and class A devices in sterile condition) may be placed on the market or commissioned until 26 May 2027, while higher risk devices (class D and class C devices) may only be placed on the market or commissioned until 26 May 2025 and 26 May 2026 respectively. During these extended transition periods, devices must continue to comply with Directive 98/79/EC and must not have significant changes in their design and intended purpose.
– provides an additional period to healthcare institutions manufacturing devices for use in their own premises (i.e. so-called in-house devices) in order to meet the conditions set out in Article 5 of Regulation (EU) 2017/746 (IVDR).
Regulation (EU) 2022/112 is available online: EUR-Lex – 32022R0112 – EN – EUR-Lex (europa.eu)

23.12.2021
To the attention of all users/distributors of PRP Blood Collection Tubes (Platelet Rich Plasma) / manufacturer ANHUI SINIC LABORATORY MEDICINE TECHNOLOGY CO. LTD., China
The National Agency for Medicines and Medical Devices of Romania warns all users and distributors of PRP Collection Tubes (Platelet Rich Plasma) products manufactured by ANHUI SINIC LABORATORY MEDICINE TECHNOLOGY CO. LTD., China to immediately stop their use or placing them on the market, since their introduction on the EU market was carried out on the basis of falsified compliance documents.
If you have acquired these products – PRP (Sodium Heparin), PRP (Sodium citrate + gel), PRP (Sodium citrate + gel + hyaluronic acid) or any other type of PRP Blood Collection Tubes of this manufacturer, accompanied by the attached documents, do not use them or make them available on the market and notify the Market Surveillance Service of the National Agency for Medicines and Medical Devices of Romania (see the contact details on the NAMMDR website).
In order to prevent the introduction of non-compliant medical devices which do not comply with the applicable regulatory requirements into the legal distribution chain, particularly in the context of the COVID-19 pandemic, please exercise maximum caution, constantly consult the website of the National Agency for Medicines and Medical Devices of Romania for such information and make sure that the products you purchase come from distributors approved by our institution, in accordance with the provisions of Article 926 of Law 95/2006 on healthcare reform, republished, with further amendments and supplementations.
descarca documentul…

14.12.2021
To the attention of Romanian hospitals and all interested parties
Invitation for hospitals to explore traceability solutions for non-sterile surgical sets – Solutions to capture full Unique Device Identifier (UDI-DI and UDI-PI)
The new EU regulations of MDR 2017/745 introduce a medical device identification system based on a unique device identifier (UDI), which allows easier traceability. These regulations require healthcare facilities to store and preserve, preferably in electronic format, UDIs of devices they have provided or which have been provided to them, if those devices are class III implantable devices. For implantable devices other than Class III, Member States shall encourage and may require healthcare institutions to store and retain, preferably in electronic format, the UDIs of the devices provided to them.
In order to find the best solutions for implementing these requirements within hospitals, following the request of the European Commission, it was decided to form a group of stakeholders from hospitals and medical device manufacturers, which will be led by MedTech Europe.
Please find attached the invitation to participate in this group.
descarca documentul…

06.12.2020
To the attention of interested persons
Submission and receipt of messages by e-mail (e-mail@anm.ro)
In line with the NAMMDR IT&C security procedures and the European Commission’s recommendations to counter phishing attacks, message authentication, reporting and compliance will only be domain-based (Domain-based Message Authentication, Reporting and Conformance – DMARC).
Security issues required for e-mail delivery to the anm.ro domain:
✓ DMARC (Domain-based Message Authentication, Reporting and Conformance)
✓ SPF (Sender Policy Framework)
✓ Reverse DNS
✓ No Open Relay

15.11.2021
To the attention of Romanian manufacturers of medical devices
UDI/Device registration – in EUDAMED
The new EU regulations of MDR 2017/745 and IVDR 2017/746 introduce a medical device identification system based on a unique device identifier (UDI), which allows easier traceability. These regulations require medical device manufacturers to submit UDI/Device information for all medical devices they place on the market. The UDI-DI/Device module of EUDAMED is used for this purpose.
From October 2021, EUDAMED’s UDI-DI/Device module is available and manufacturers can already enter the UDI/Device information into the system voluntarily.
For more information, we recommend that you access the European Commission website: https://ec.europa.eu/health/md_eudamed/udi_devices_registration_ro
The guideline providing all the information required in order to register UDI/Devices into the Eudamed can be accessed here: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/md_eudamed_udi-devices-user-guide_en.pdf

20.07.2021
To the attention of Romanian manufacturers of medical devices/authorised representatives
Registration of “Legacy devices” into the EUDAMED
“Legacy devices” are defined as medical devices, active implantable medical devices and in vitro diagnostic medical devices covered by a valid EC certificate of compliance issued in accordance with Directive 93/42/EEC, Directive 90/385/EEC or Directive 98/79/EC and which continue to be placed on the market after the date of application of Regulation (EU) 2017/745 (MDR) or Regulation 2017/746 (IVDR).
“Legacy devices” are subject to MDR or IVDR registration requirements, with some exceptions, such as the assignment of a base UDI-DI and a UDI-DI.
Manufacturers will have the possibility to register any of the “legacy devices” in EUDAMED. Indications regarding the registration of “Legacy devices” in EUDAMED are provided in the document “MDCG 2019-5 Registration of legacy devices in EUDAMED April 2019” (https://ec.europa.eu/docsroom/documents/34922).
Although the assignment of a basic UDI-DI and UDI-DI is not necessary for a “legacy device”, in order to keep the same standard structure and identifiers for all devices registered into the EUDAMED, an EUDAMED DI identifier (the equivalent of the UDI- Basic DI) will be required and a EUDAMED ID (if no UDI-DI has been assigned) will be generated from the EUDAMED DI.
The basic UDI-DI will never be applicable and assigned to a “legacy device”, only the EUDAMED DI will.
The UDI-DI can be used to identify a legacy device into the EUDAMED, however, only one device identifier will be assigned to a “legacy device”, as follows:
• either a UDI-DI (where EUDAMED DI is automatically generated),
• either a EUDAMED DI (where the EUDAMED ID is automatically generated).
For more information, please read the document “Management of Legacy Devices – MDR EUDAMED”: https://ec.europa.eu/health/sites/default/files/md_eudamed/docs/legacy_dvc_management_en.pdf

07.06.2021
To the attention of Romanian manufacturers of medical devices/authorised representatives
European Medical Device Nomenclature (EMDN)
We inform you that starting from 04.05.2021, the European Medical Device Nomenclature (EMDN), as defined by Article 26 of the Medical Device Regulation (EU) 2017/745 (MDR) and Article 23 of the Medical Device Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), its platform and the English translation validation consultation are officially posted online: https://webgate.ec.europa.eu/dyna2/emdn/.
The Italian version of the nomenclature is deemed final and official. The English version is subject to validation through this online consultation for one month.
The EMDN is used by manufacturers to register medical devices into the EUDAMED, where each device will be associated with each unique device identifier – device identifier (UDI-DI). The EMDN is intended to support all actors in their activities under MDR / IVDR and provides key descriptions of medical devices.
EMDN is characterised by its alphanumeric structure which is established in a multi-level hierarchical tree. It groups medical devices into three main tiers. The first hierarchical level is the “Category” level, the second is the “Group” level, and the third is the “Type” level.
Each medical device is classified by an alphanumeric code containing a letter referring to “Category”, 2 numbers referring to “Group” and between 1 and 5 two-digit numbers referring to “Type”, up to a maximum of 7 levels of detail.
There are 22 categories for the first hierarchical level “Category”. Each is identified by a letter of the alphabet. Each category includes devices regulated in the MDR or IVDR. The categories are divided into 8 anatomical categories.
The second hierarchical level “Group” contains 146 groups of anatomical / functional medical devices. These are the differentiations to distinguish between devices in these categories and are identified by two-digit numbers from 01 to 99 for each category. Number 90 identifies groups of devices which possess various characteristics not related to the existing groups, while number 99 (“other”) is reserved for medical devices which are not included in the already existing groups and which shall be classified in future updates.
“Type” represents the third hierarchical level. It can be expanded to 7 levels of detail, each defined in the code by a two-digit number. Each type level includes medical devices characterised by a high affinity for use, intended use, or a similar clinical method.
As regards accessories, each accessory will inherit the EMDN classification code of the medical device with which it is associated. If the accessory can be used with several devices belonging to different groups, it will be assigned the predominant type code.
Although the EUDAMED is not yet fully operational, implementation of the first module on actor registration started in December 2020, while the second module for UDI registration was announced for September 2021. Manufacturers are therefore advised to already start preparing for these EUDAMED registration requirements in order to be ready to submit the requested information as soon as the various database modules become operational.

18.05.2021
To the attention of stakeholders
The unique identification system of medical devices (UDI), in accordance with Regulations (EU) 2017/745 and 2017/746 on medical devices.
descarca documentul…

12.01.2021
To the attention of Romanian manufacturers of medical devices/authorised representatives/importers
Using the EUDAMED “actors” registration module and the single registration number (SRN)
The setup of a European database on medical devices (EUDAMED) is one of the key aspects of the new regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746).
The EUDAMED will provide a real picture of the lifecycle of medical devices made available in the European Union (EU). It will integrate various electronic systems to collect and process information about medical devices and related companies (e.g. manufacturers). In this respect, the EUDAMED aims to increase overall transparency, including through better access to information for the public and healthcare professionals, and to strengthen coordination between the various EU Member States.
EUDAMED contains 6 modules, as follows:
1. Registration of the actors
2.unique device identification (UDI) and registration of medical devices,
3. notified bodies and issued certificates,
4. clinical investigations and performance studies,
5. vigilance
6. Market surveillance.
The actor registration module is active as of 1 December 2020. In accordance with Article 30 (1) of the MDR, the actor registration module must allow the creation of a single registration number (“SRN”) and the collection and processing of information necessary to identify the manufacturer (including producers of system/procedure packs) and , if applicable, of the authorised representative and importer. As such, the actor registration module is a prerequisite for the use of the other EUDAMED modules and facilitates a secure way of accessing the EUDAMED.
Actors involved in the EUDAMED are:
• Supervisory bodies
– The European Commission
– Competent Authorities (CAs), including designation authorities
– Notified Bodies (NB)
• Economic operators
– Manufacturers
– Manufacturers of systems and procedures packages
– Authorised representatives
– Importers
• Sponsors (clinical investigation financers)
Following the evaluation and approval of the request by the competent national authority in question (the NAMMDR), the EUDAMED generates the SRN of the economic operator to the competent national authority and transfers it to the requesting economic operator.
More information here: https://ec.europa.eu/health/md_eudamed/actors_registration_ro.
You can access the guide containing all the information needed to register actors in the Eudamed at:
https://ec.europa.eu/health/sites/health/files/md_eudamed/docs/md_user_guide_actor_module_en.pdf.

04.09.2020
To the attention of Romanian manufacturers/authorised representatives/importers
The use of the EUDAMED “actors” registration module and of the single registration number (SRN) in member states
Article 33 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereinafter referred to as the „MDR”) establishes that, following consultation with the Medical Devices Coordination Group (MDCG), the Commission will create, maintain and manage the European database on medical devices (EUDAMED). EUDAMED contains several electronic systems (so-called “modules”), including an electronic system for registering economic operators, called the Actor registration module.
In line with Article 30 (1) of the MDR, the actor registration module should allow the setup of a single registration number („SRN”), gathering and processing the information required in order to identify the manufacturer (as well as the producers of system/procedure packs) and, if appropriate, the authorised representative and importer. Therefore, the actor registration module is a prerequisite for using the other EUDAMED modules and facilitates a secure way of accessing EUDAMED.
The responsibility for assigning a SRN to economic operators belongs to the NAMMDR, as the competent authority. For this purpose, Article 31 paragraph (2) stipulates that, after the verification and validation of the data entered into the EUDAMED by an economic operator, the competent authority of a member state must obtain a SRN from the actor registration module and approve its release to the manufacturer, the authorised representative or the importer who requested this.
On 30 October 2019, the Commission published an information by which it reached the conclusion that the full functionality of the EUDAMED requires the availability and full operation of all six modules and confirmation through an audit. The information foresees the launch of a fully functional EUDAMED for May 2022.
However, in its meeting of 12 March 2020, the MDCG agreed that each EUDAMED module can be made available, gradually, as soon as it is operational. The commission has confirmed the availability to launch the actor registration module starting with 1 December 2020. MDCG members strongly encourage the use of the actor registration module by all relevant actors in their territories, including the use of the SRN by actors, as stipulated in the MDR (e.g. specifying the SRN on certificates).
MDCG members agree that double registration requirements for actors should be avoided as much as possible. Therefore, consideration should be given to actors obtaining an SRN in accordance with actor registration requirements (for manufacturers, authorised representatives, importers, producers of system/procedure packs) to the extent that national legislation allows this. In such cases, actors should comply with MDR obligations and requirements related to both the registration of the relevant actors (via the “actors” registration module) and the use of their SRN, as required.
The NAMMDR announced its intention to participate in the voluntary registration into the EUDAMED, as soon as the actor registration module is functional.
Taken from: https://health.ec.europa.eu/system/files/2020-08/2020-15-position-paper-actor-registration-module_en_0.pdf

16.06.2020
To the attention of interested persons
The NAMMD would like to inform you about the 7th Romanian Pharmacovigilance Workshop which will be held in Bucharest, between 21- 23 September 2020 „EudraVigilance news, Signal detection, Covid-19 pharmacovigilance, MedDRA 23.1, inspections and audits, risk management plans and more…” presented in English by Dr. Calin A. Lungu, CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg. Detalied information are available at Agenda.
The event will take place at Crown Plaza Hotel, Bvd. Poligrafiei 1, sector 1, Bucharest.
For registration, please download the registration form (Registration Form) or contact the event organizer in Romania at the following contact data:
Mr. Alexandru Popescu, Business Travel Turism S.R.L.
Fax: +4021 3126708, Tel: +4021 2315615
Email: alexandru.popescu@businesstravel.ro
*Due to possible travel or meeting restrictions that might be in place, this workshop may be held online with the same agenda.

12.03.2020
To the attention of interested persons
Considering the current epidemiological context, in order to best possibly avoid trips for document exchange, the NAMMDR has decided on restriction, from 13 March to April 15 2020 (with possible extension should the situation so require), of the activity of the Registry service involving contact with the public. Therefore, documents may be submitted as follows:
Medicines for human use
– by regular mail, to Str. Av. Sănătescu nr. 48, sector 1, 011478 Bucharest, Romania
– by fax, to: + 4021-316.34.97
– by electronic mail, to:
– registratura@anm.ro
– CESP,
– the single electronic contact point (PCU-e).
Medical devices
– by regular mail, to: Bd. Nicolae Titulescu 58, Sector 1, 011144, Bucharest, Romania
– by fax, to: + 4021-222.86.83
– by electronic mail, to:
– dgdm@anm.ro,
– the single electronic contact point (PCU-e).
To receive documents issued by the NAMMDR during the same period, we recommended using courier services.
At the same time, all parties interested are advised that meetings requested shall be suspended during the specified period.
Thank you for your understanding and cooperation.

08.11.2011
Customer satisfaction evaluation questionnaire
Contributing to permanent improvement of Technical Laboratories Department work, we hereby kindly invite our customers to fill in the attached questionnaire, to be returned to fax nr. +40 212228683:
download document …

08.11.2011
News on medical devices
In result of the monitoring of technical-medical units work, certified by the Minister of Health or under approval, that also have certified and implemented Quality Management System SR EN ISO 9001:2008 or SR EN ISO 13485:2004 with certifying bodies accredited by a national accreditation body (the RENAR- Romanian Accreditation Association or similar), as well as of consultations and dialogue conducted with part of these certifying bodies, the NAMMD Department for Evaluation of technical-medical units specifies a follows:
-The field of medical devices is regulated by European directives (93/42, 98/79, 90/365) and, based on Article 6 of Law No.176/2000 on medical devices, as republished and amended, as well as of Order of the Minister of Health No.1636/2007, as amended, the NAMMD performs evaluation of organizations providing services in the field of medical devices (medical optics, orthopaedic/hearing/other type prosthetics or repair, verification and setting into operation of medical devices);
-The NAMMD “sets up specific technical procedures in medical devices”, “on Ministry of Health request, it evaluates and/or audits legal and natural entities applying for approval of operation” (Article 7 of the law mentioned above) and prepares the assessment report based on which the Ministry of Health grants such approval (Article 2 (2) of Order of the Minister of Health No.1636/2007);
-The assessment report prepared by the NAMMD confirms that the natural or legal person seeking approval of operation meets all the working conditions, technical-material endowment, qualification, capability, procedures and instructions to perform that activity.
Long term monitoring of the quality of services rendered by medical devices service providers has shown the NAMMD that not all can prove capacity to provide services consistently meeting both customers’ expectations and regulatory requirements applicable to this field. In that respect, certification of the quality management system has proved imperative, as proof of meeting such requirements.
Given that activities assessed are conducted in the field of medical devices and have serious implications on public health, based on legislation in the field and taking into account the limited number of accredited bodies in Romania for certification of the quality management system according to SR EN ISO 13485 (specific to medical devices), and that most bodies accredited for SR EN ISO 9001:2008 certification do not employ technical experts and auditors qualified and experienced in medical devices, in order to ensure compliance of work by medical devices service with requests of such standards, the NAMMD has prepared its own assessment technical procedure.
The institution has not sought control of such activities, but only to ensure their conduct by suitably qualified personnel.
Whereas CAEN Codes 3313, 3314 and 332 codes do not make explicit reference to repair, verification and start-up of medical devices, and NAMMD experience has not found that auditors/experts of audit teams are at all times acquainted with laws specific to the field, a procedure for approval of certifying bodies has been found necessary; therefore, the response of certifying bodies has been difficult to understand, inasmuch that the NAMMD only target had been a more thorough analysis of compliance with specific requirements in the field.
As an approach that has been misunderstood, the procedure for approval of certifying bodies for assessment of technical-medical units has been discontinued; in that respect, only the requirement concerning the quality management system certification by an accredited certifying body has been maintained.
As before, evaluation of technical-medical units applying for grant of approval for operation, as well as surveillance assessment of these units are currently conducted by the NAMMD-EUTM Department, based on a procedure of its own.