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.