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.