Medical Devices Regulation / MDR (EU) 2017/745
Regulation (EU) 2017/745 – the Medical Device Regulation (MDR) – has been fully in force since 26 May 2021, replacing the previous EU Directive 93/42/EEC (Medical Device Directive, MDD).
Key areas of the MDR:
- Classification: four risk classes (I, IIa, IIb, III) under stricter rules in Annex VIII
- Conformity assessment: more stringent requirements, particularly from Class IIa upwards (Notified Body required)
- Clinical evaluation: continuous obligation, including for Class I products
- Post-market surveillance: active market monitoring and mandatory incident reporting
- UDI system: unique product identification and EUDAMED registration
- Technical documentation: more comprehensive requirements than under MDD
As an EU Regulation, the MDR is directly applicable law in all EU Member States – without national implementing acts.
In-vitro diagnostic devices are governed by the parallel Regulation (EU) 2017/746 (IVDR). The MDR does not cover PPE; that falls under PPE Regulation (EU) 2016/425.
Frequently asked questions
What are the key changes of MDR compared to MDD?
The MDR tightens clinical evaluation requirements, introduces UDI and EUDAMED, expands technical documentation requirements, raises standards for Notified Bodies, and introduces mandatory post-market surveillance. Transition periods ran to 2024–2027 depending on device class.
Does the MDR apply to all medical devices in the EU?
Yes. The MDR applies to all medical devices placed on the EU market – regardless of where the manufacturer is located. Non-EU manufacturers require an EU Authorised Representative.