Regulatory compliance under the EU Medical Device Regulation (MDR) is non-negotiable. For manufacturers placing devices on the EU market, the appointment of a Person Responsible for Regulatory Compliance (PRRC) is a legal requirement — and one that brings operational pressure. Whether you're a non-EU manufacturer needing an authorised representative or an EU-based firm without internal PRRC capacity, the risks of non-compliance are high. You need a partner who not only understands the complexities but can step in with qualified assurance.

Eurofins Medical Device Consulting is that partner. We provide PRRC services, giving you immediate access to highly qualified regulatory professionals with experience. From day one, we help ensure your devices are released in accordance with a compliant quality management system. Our experts oversee and verify that device conformity is appropriately checked before market release; technical documentation and EU declarations of conformity are up-to-date; post-market surveillance systems are functioning as required; all reporting obligations — including serious incident reports and trend reporting — are fulfilled; and statements for investigational devices are issued when necessary.

Alongside PRRC support, our QA/RA management solutions help you build or reinforce your internal systems. Our teams support you through the entire lifecycle of your medical device by offering vigilance, re-certification, General Safety and Performance Requirements (GSPR), Post-Marketing Surveillance (PMS), and Post Market Clinical Follow-up (PMCF).