To the attention of interested persons
List of training providers with the topic of legislation in the field of medical devices, approved by the NAMMDR. In line with the Rules, in order to obtain an operating permit, the economic operator must have sufficient and qualified/trained staff for the activity carried out/the field in which he/she operates.
The Medical Device Regulatory Compliance Officer (PRCR) and Warehouse Manager must demonstrate attendance at medical device legislation training courses.
Articles 9 (3) of the Rules provides:
(3) The training courses will be carried out by authorised physical and legal persons whose object of activity is to provide the training provided for in paragraph (2) b) and who provide proof of professional experience in regulatory or conformity assessment activities related to medical devices, as follows:
a) in regulatory activities with professional experience of at least four years in the field of medical devices or participation in working groups specific to medical devices at European Commission/EU council level;
b) in medical device compliance assessment activities within a notified compliance assessment body on the specific medical device directives, for at least two years.
Since issuance of Order of the Minister of Health no. 566/2020, the NAMMDR has been so far in contact with the companies that issued diplomas/certificates as a result of organising training courses about the medical devices legislation and which we have found in the dossiers submitted by economic operators in order to approve the activity carried out. According to the internal work procedure, as specified in Art. 7 of the Rules, evidence of meeting the requirements of Art. 9 (3) by the employed lecturers have been required in order to teach these training courses.
Up to this date, the companies that have proven that they comply with these requirements are as follows:
|No.||Legal entity name||Name and surname of the lecturer|
|1.||MEDTECH CONSULTING SRL||MARGARETA MIHALACHE|
|2.||MEDICAL DEVICE LEX SRL||LAZĂR IORDACHE
|3.||MEDIA KOMPASS SRL||NICOLAE FOTIN|
|4.||CERTINSPECT REGISTER SRL||GHEORGHE NEAGU|
|5.||ASOCIAȚIA DE STANDARDIZARE DIN ROMÂNIA – ASRO||MARGARETA MIHALACHE|
|6.||EUROASIA SRL||CHRISTIAN HEINRICH|
|7.||OTD GLOBAL PRO SRL||CHRISTIAN HEINRICH|
|8.||POPI INVEST CORP SRL||GHEORGHE NEAGU|
When the list undergoes changes, we shall immediately post the revision. In this regard, please check the NAMMDR website regularly for updated information.
NOTE: The NAMMDR constantly monitors the activity of training providers. In this respect, if you are dissatisfied with the performance of the training providers regarding the manner in which the training is carried out or the quality of the provided services, you can report the negative aspects online at email@example.com or firstname.lastname@example.org.