News on implementation of the MDR/IVDR

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.

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…

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