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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. Submit one request — ECP matches you to qualified PRRC service providers.

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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 EC REP providers on ECP 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.

Find your PRRC Service Provider

Submit one request to ECP and receive proposals from qualified PRRC service providers experienced in MDR and IVDR Article 15 compliance. Free, no commitment.

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
EC REP Cost CalculatorEstimate combined EC REP + PRRC annual costs