21.08.2023
To the attention of interested persons
List of training providers on medical device legislation, approved by the NAMMDR
In line with the Rules, in order to obtain an operation permit, the economic operator must have sufficient and qualified/trained staff for the activity it carries out/the field in which it operates.
The person responsible for compliance with the (PRCR) regulations specific to the medical device field and the warehouse manager must provide proof of participation in training courses on medical device legislation.
Art. 9 paragraph (3) of the Rules provides the following:
(3) The training courses shall be carried out by authorised individuals and legal entities whose object of activity is the provision of training provided for in paragraph (2) point b) and who provide proof of professional experience in regulatory activities or conformity assessment of medical devices, as follows:
a) in regulatory activities with at least of a 4-year professional experience in the field of medical devices or participation in working groups specific to the field of medical devices at the level of the European Commission/Council of the European Union;
b) in medical device conformity assessment activities within a notified conformity assessment body on the specific medical device directives, at least two years.
Since the appearance of Order of the Minister of Health 566/2020, the NAMMDR has contacted companies that have issued diplomas/certificates as a result of supporting training courses on the subject of medical device legislation and which we have found in the files submitted by economic operators, in order to approve the activity carried out. Based on the internal working procedure, as specified in Art. 7 of the Rules, evidence of compliance with the requirements of Art. 9 (3) was requested by the lecturers teaching these courses.
To date, the companies having proven compliance with these requirements are the following:

When the list undergoes changes, we shall publish its revised version immediately. In this regard, please check the NAMMDR website permanently for updated information.
NOTE: The NAMMDR permanently monitors the activity of training providers. In this regard, if you are dissatisfied with the performance of training providers regarding the way the training is conducted or the quality of the services, you can report the negative aspects to da@anm.ro or dgdm@anm.ro