The EU’s Medical Device Regulation

Staying up-to-date with the new requirements

Staying up-to-date with the new requirements

THE EU'S MEDICAL DEVICE REGULATION (MDR)


Medical device manufacturers seeking market access to the European Union (EU) face major changes in the EU’s decades-old regulatory framework. The EU’s Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. The MDR replaces the EU’s previous Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC)

TÜV SÜD is closely following developments related to the MDR, and will regularly provide updated information to our clients through various resources such as webinars, training, information factsheets etc. These and other resources are designed to help medical device manufacturers stay fully informed about the changes. 

Download the EU MDR guide 

 

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