EU MDR – Medical Device Regulation Certification for Market Access

The EU Medical Device Regulation (MDR – Regulation (EU) 2017/745) entered into force on 26 May 2017 and became fully applicable on 26 May 2021, replacing the former Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD 90/385/EEC).

Transition deadlines have been extended for various reasons to support continued access to medical care in the EU.

• European Commission / Nando (TÜV NORD CERT Notified Body) und Designation scope
• MDCG (Guidance - MDCG endorsed documents and other guidance)
• EUDAMED (European Database on Medical Devices)

MDR was introduced to strengthen patient safety and improve the transparency of medical device regulation across the EU. It addresses weaknesses in the previous system by introducing stricter clinical evaluation, post-market surveillance, and traceability through UDI (Unique Device Identification). MDR also expands the scope to include more types of products and ensures a higher standard of quality for devices marketed in Europe.

All devices previously covered under MDD and AIMDD remain regulated under MDR. However, new classifications and product groups have been added, including:

- Reusable surgical instruments – now classified under Class I (reusable surgical) and require Notified Body involvement for aspects like cleaning, sterilization, and reprocessing.

- Non-medical products listed in Annex XVI of the MDR

If your device does not have a valid MDR certificate (or extended MDD certificate under the transitional rules), it cannot be legally placed or made available on the EU market.