Find a PRRC Service Provider

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. An external PRRC is an option for:

• Micro and small non-EU manufacturers without regulatory affairs staff of their own
• Start-ups and other micro or small enterprises that cannot justify a full-time in-house PRRC (medium-sized companies must have one in-house)
• Micro and small manufacturers transitioning from MDD/AIMDD to MDR who lack MDR-specific expertise
• EU Authorised Representatives, which must have a PRRC permanently and continuously at their disposal (Article 15(6))

What does a PRRC service provider do?

• Acts as outsourced PRRC under MDR/IVDR Article 15, named in manufacturer documentation
• Ensures the conformity of devices is appropriately checked, in accordance with the QMS, before a device is released
• Ensures the technical documentation and the EU declaration of conformity are drawn up and kept up to date
• Ensures post-market surveillance obligations are complied with (Article 10(10))
• Ensures the vigilance reporting obligations of Articles 87 to 91 are fulfilled
• Coordinates with EUDAMED registration and the EU Authorised Representative
• For investigational devices, ensures the statement required by Annex XV, Chapter II, Section 4.1 is issued

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 a course of study recognised as equivalent) in law, medicine, pharmacy, engineering or another relevant scientific discipline, plus at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices. Alternatively, four years of professional experience in regulatory affairs or in quality management systems relating to medical devices qualifies without a degree. Manufacturers of custom-made devices may rely on two years of experience in a relevant field of manufacturing. IVDR requirements are analogous.

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