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MDR / IVDR Art. 15

Find a PRRC Service Provider

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. PRRC services are provided by AFINA s.r.o., the company behind ECP, through getEAR.eu.

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Who needs outsourced PRRC services?

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:

  • Non-EU manufacturers without EU-based regulatory affairs staff
  • Start-ups and SMEs that cannot justify a full-time in-house PRRC
  • Manufacturers transitioning from MDD/AIMDD to MDR who lack the required MDR-specific expertise
  • EU Authorised Representatives who need to fulfil their own PRRC obligations

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.

What does a PRRC service provider do?

  • Acts as outsourced PRRC under MDR/IVDR Article 15, named in manufacturer documentation
  • Ensures conformity of devices before they are placed on the EU market
  • Oversees technical documentation completeness and accuracy
  • Manages post-market surveillance reporting (PSUR, trend reports, PMCF plans)
  • Handles vigilance obligations and serious incident reporting to EUDAMED
  • Coordinates with EUDAMED registration and the EU Authorised Representative
  • Provides sign-off on regulatory submissions and audit readiness reviews

Documents and information typically required

  • Device description and intended purpose
  • MDR/IVDR risk class of your device(s)
  • Current state of technical documentation (Technical File / Design Dossier)
  • CE marking status (MDD legacy, MDR transition, or new MDR application)
  • Number of distinct device models requiring PRRC coverage
  • Any existing Notified Body certificate numbers
  • Current post-market surveillance and vigilance procedures

PRRC qualifications under MDR Article 15

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 EU Authorised Representatives include PRRC services in their standard mandate. If you need both EC REP and PRRC, ask for combined coverage — it reduces costs and administrative overhead compared to contracting separately.

Find your PRRC Service Provider

PRRC services are provided by AFINA s.r.o., the company behind ECP, through getEAR.eu.

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Related services

ServiceDescription
EU Authorized Representative (EC REP)Mandatory EU-based representative for non-EU medical device manufacturers under MDR/IVDR Art. 11
UK RepresentativeUK Responsible Person for UKCA-marked medical devices on the GB market
GPSR Responsible PersonFor consumer products not covered by MDR/IVDR under GPSR 2023/988
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