European regulators have published new guidance documents addressing persons responsible for managing compliance with the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR).

PRRC under the MDR and IVDR

The new European Commission’s guidance on persons responsible for regulatory compliance (PRRC) explains that manufacturers, Authorized Representatives and micro and small manufacturers must designate at least one staff member responsible for ensuring compliance to the MDR and/or IVDR as appropriate according to Article 15 of the Regulation. PRRC qualifications are specific for each of these three operators.

A manufacturer’s PRRC must have either a formal qualification (university degree) in addition to a minimum of one year’s professional experience in medical device regulatory affairs or quality management; or four years of experience in regulatory affairs or quality management pertaining to medical devices.

• PRRC qualifications obtained outside the European Union should be recognized by an EU Member State as equivalent to an EU qualification;
• Organizations that have more than one legal manufacturer must designate a PRRC for each of its manufacturing entities;
• European regulators will generally assume that manufacturers based outside the EU will have PRRCs located outside the EU, as well.

Micro and small manufacturers will have the option to subcontract their PRRC functions to third parties that meet qualifications laid out for manufacturer PRRCs in Article 15 of the MDR.

European Authorized Representatives may also outsource their PRRC responsibilities to third parties, provided their subcontractors meet stated qualifications.

Finally, the guidance explicitly forbids a single individual from serving as PRRC for both an Authorized Representative and a manufacturer based outside the EU.

“There is a clear desire within the Regulations for the authorised representative to be adding an additional level of scrutiny and ensure that the supervision and control of the manufacture of devices, and the relevant post-market surveillance and vigilance activities are adequately effected,” states the guidance.

Additional European MDR and IVDR resources from Emergo by UL:

• European CE Mark strategy for medical device companies
• European CE Marking consulting for IVD devices
• European Authorized Representative in-country representation
• On-site MDR training for manufacturers
• Whitepaper: Understanding Europe’s Medical Devices Regulation (MDR)
• Whitepaper: The European In-vitro Diagnostic Medical Devices Regulation (IVDR)