PRRC - Person Responsible For Regulatory Compliance-MDR/IVDR Article 15
With the Medical Device Regulation – MDR (EU 2017/745) and In Vitro Diagnostic Regulation –
IVDR (EU 2017/746), European regulators aim to ensure companies have a regulatory expert – a Person
Responsible for Regulatory Compliance (PRRC) – at their disposal, to ensure that the company is meeting
certain specific EU requirements
Requirements for PRRC in the Regulations
and in the MDCG 2019-7
Both the manufacturers and the Authorized Representative are required to have within their organisation,
or at their disposal, at least one PRRC who possesses the proper expertise and qualification in the field
of medical devices or in vitro medical devices, as applicable
To be a qualified person you have to have the following skills either:
Option 1:
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.
Any qualification acquired outside the EU, including any university diplomas or certificates, should have been recognised by an EU Member State as equivalent to the EU corresponding qualification.
And
At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices and in vitro diagnostic (the professional experience in regulatory affairs or in Quality Management Systems should be related to the EU requirements in the field.
Option 2:
Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices/ in vitro diagnostics.
If you wish to sell your product in the EU, we can provide a team of knowledgeable regulatory specialists to help with PRRC services and make sure you comply with MDR 2017/745 and IVDR 2017/746
For further details, please Contact Us