| Specific legislation Law no. 95/2006, republished, as subsequently amended – Title XX – Medical Devices / Chapter 4, Sanctions – Article 934 ÷ 936 |
| Economic operators fined by the NAMMDR-DGDM-DRSP download document …  |
| News / Alerts |
| 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 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. 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 regarding some market surveillance measures for products regulated by European Union legislation, which harmonize their marketing conditions, stipulates that surveillance of products placed to the market and/or commissioned is carried out also by organisation of unannounced controls and point checks. In view of the above, we inform you that unlawfully obstructing, in any form, the authorised persons to exercise 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 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. |
| To the attention of interested persons DECISION NO.44377E / 05.05.2015 download document … |
| To the attention of legal representatives and persons responsible for medical devices in hospitals As the 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 through measures taken to ensure that the appropriate legislation is applied, and that compliance with this legislation is ensured throughout the supply chain, via appropriate controls. In this capacity, the NAMMDR has the right to carry out on-site inspections and physical checks of products, without prior notification, to enter any premises, any area or means of transportation that the concerned economic operator uses them for purposes related to his 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 and amendment of Directive 2004/42/EC and Regulations (EC) No. 765/2008 and (EU) No. 305/2011). Article 93 of Regulation 2017/745 on medical devices provides that the competent authority carries out both announced inspections and, if necessary, unannounced, 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: – wether 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 medical devices are used only during their validity period, when applicable, and that they do not deviate 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. Some of the legal obligations of professional users of medical devices are available online at: https://www.anm.ro/dispozitivo-medicale/supraveghere-in-utilizare/ The legislation related to the control is the following: – Law No. 95 Republished*) of 14 April 2006 on healthcare reform – Title XX *) Includes all amendments to the official document published in the Official Gazette of Romania, including those provided in: Government Ordinance No. 37/31.08.2022, published in the Official Gazette of Romania No. 857/31.08.2022 This Law is available online at: (https://www.anm.ro/_/DM/LEGISLATIE/legea%2095_titlul%20XX_05.09.2022.pdf ) – ORDER No. 2.219 of 14 July 2022 on control by periodic assessment of the medical devices in use, the assessment of the performance of second-hand medical devices put into operation and the issuance of the approval for use of medical devices belonging to the means of intervention for pre-hospital emergency medical care; This Order is available online at: The respective order can be accessed at the link below: (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 the manner of reporting suspected serious incidents related to medical devices; This Order is available online at: (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; This Order is available online at: (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. 882/2004 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC; This Regulation is available online at: (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 Emergency Ordinance is available online at: (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 at: (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20220128&qid=1651491186034 ) Through the checks carried out and the elimination of non-compliant medical devices, we want to ensure a high level of protection of patients and users health and safety , these actions targeting the general public interest. |
| To the attention of interested persons To the attention of interested persons The National Agency for Medicines and Medical Devices (NAMMD) expresses its concern that the population has access, at any time, to medical devices designed and manufactured in such a way that, if they are used in the conditions and in accordance with their intended purpose, they do not compromise the clinical condition or safety of patients or the safety and health of users or, as the case may be, of other persons. It is intended that any risks which could be associated with their use are considered acceptable, compared to the patient’s benefits, and that they are compatible with a high level of health and safety protection. Lately, although mostly verbally, there have been signals from patients/users, stating that some medical devices failed to deliver their promised therapeutic effect. The NAMMD kindly asks all interested stakeholders: healthcare professionals, patients, the general public and the media to inform the NAMMD about the appearance on the market of non-compliant medical devices, without CE marking or whose operation may endanger the life and health of patients. The NAMMD will improve market surveillance and controls both at the sites of manufacturers and particularly importers, distributors and traders of medical devices so that, through joint effort and cooperation with other institutions with competences conferred by the law in this field, we can create an environment conducive to protecting the lives and health of citizens. For any complaint regarding a medical device, please e-mail sesizaridm@anm.ro |
| To the attention of stakeholders The NAMMDR informs all stakeholders that starting from the date of this announcement, data related to controls carried out by the General Directorate for Medical Devices – Market Surveillance Service as well as the measures provided in such cases will be solely posted in the Medical Devices – Market Surveillance section. download document …
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| To the attention of stakeholders The NAMMDR warns stakeholders about the existence on the Romanian market of NIFTY prenatal testing kits, procedures offered to pregnant women by medical analysis laboratories in order to identify the risk of trisomy 21, 18, 13 in the foetus, which contain containers/ medical devices (IVD) non-compliant in terms of labelling. In the context of the market surveillance activity, the NAMMDR prohibited the use of such tests in 2 analysis laboratories in the Municipality of Bucharest. We hereby request all medical analysis laboratories in Romania, which carry out this type of NIFTY testing, to inform the NAMMDR, regarding the conduct of this activity, at the e-mail address: mdevice@anm.ro, in order to assess the compliance of the (IVD) medical devices used. |
National Agency for Medicines and Medical Devices of Romania
