MDR / IVDR Art. 15
Under MDR 2017/745 and IVDR 2017/746 Article 15, every manufacturer placing medical devices on the EU market must have at least one qualified Person Responsible for Regulatory Compliance. Non-EU manufacturers without an in-house PRRC can outsource this function. Submit one request — the scope can be matched with qualified PRRC service providers.
Any manufacturer placing medical devices or IVDs on the EU market under MDR 2017/745 or IVDR 2017/746 must have at least one Person Responsible for Regulatory Compliance. This applies to:
PRRC is a legal requirement, not an optional role. Failure to have a qualified PRRC can result in non-compliance findings, suspension of EUDAMED registration, and inability to place devices on the EU market.
The MDR specifies that the PRRC must hold a university degree (or equivalent) in law, medicine, pharmacy, engineering or a natural science, plus at least one year of experience in regulatory affairs or QMS. Alternatively, four years of professional experience in those fields qualifies without a degree. IVDR requirements are analogous.
Many EC REP providers on AFINA include PRRC services in their standard mandate. If you need both EC REP and PRRC, request combined coverage — it reduces costs and administrative overhead compared to contracting separately.
Submit one request to AFINA and receive proposals from qualified PRRC service providers experienced in MDR and IVDR Article 15 compliance. Free, no commitment.
| Service | Description |
|---|---|
| EU Authorized Representative (EC REP) | Mandatory EU-based representative for non-EU medical device manufacturers under MDR/IVDR Art. 11 |
| GPSR Responsible Person | For consumer products not covered by MDR/IVDR under GPSR 2023/988 |
| EC REP Cost Calculator | Estimate combined EC REP + PRRC annual costs |
Send the product details and we will suggest the next practical compliance step.