How does the Medical Devices Regulation (MDR) affect product compliance?

Dutch term: Verordening medische hulpmiddelen (MDR) | Legal basis: Regulation (EU) 2017/745

The Medical Devices Regulation (MDR, Regulation (EU) 2017/745) is the EU regulatory framework for medical devices, in force since 26 May 2021. It replaces the earlier Medical Devices Directive with a significantly more demanding regime covering classification, conformity assessment, clinical evaluation, post-market surveillance, unique device identification (UDI) and the EUDAMED database.

Manufacturers must classify their device according to the MDR risk classification rules (classes I, IIa, IIb, III), carry out the applicable conformity assessment procedure (with mandatory notified body involvement for all classes except low-risk class I), compile comprehensive technical documentation including clinical evaluation, implement a quality management system, and register in the EUDAMED database. The MDR has created significant capacity pressure on notified bodies, leading to extended certification timelines.

Why it matters for international businesses

For medical device manufacturers and importers placing devices on the EU market through the Netherlands, MDR compliance is a prerequisite for market access. MAAK Advocaten advises on the regulatory framework, the interaction with commercial supply contracts, and defence against enforcement actions by the Health and Youth Care Inspectorate (IGJ).