A Person Responsible for Regulatory Requirements (PRRC) is required by the Medical Device Regulation 2017/745 (MDR, Article 15.6) and In vitro Medical Device Regulations 2017/746 (IVDR, Article 15.6) for EU Authorised Representative (EUAR).
As per MDR (Article 15.6)and IVDR (Article 15.6), a PRRC shall possesses the necessary regulatory requirements demonstrated by either of the following qualification:
– A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical device or in vitro diagnostic medical devices;
– Four years of professional experience in regulatory affairs or in quality management systems relating to medical device or in vitro diagnostic medical devices.
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How Evnia-AR helps?
Evnia-AR has a dedicated internal team that fulfil the role of PRRC. A dedicated PRRC who possesses the requisite expertise regarding the regulatory requirements for medical devices and in vitro medical devices, will be assigned to each company.
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