What is a PRRC – and How Can Glaze Medical Help?
A PRRC – Person Responsible for Regulatory Compliance – is a mandatory statutory role for all medical device manufacturers under Article 15 of the EU MDR and IVDR. The PRRC ensures that devices conform to your QMS prior to release, that the Technical File and Declaration of Conformity are kept up to date, and that post-market surveillance and vigilance obligations are met.
To qualify as a PRRC, EU law requires either a relevant university degree plus at least one year of regulatory/quality experience in medical devices, or four years of professional experience in regulatory affairs or QMS relating to medical devices. Micro and small enterprises may outsource the role permanently and continuously to a qualified external expert.
Glaze Medical provides experienced external PRRC specialists meeting all MDR/IVDR qualification requirements—backed by dedicated professional liability insurance covering the role. Contact us for a reliable, compliant PRRC arrangement.