Medical Device Regulation (MDR)

The new EU Medical Device Regulation (MDR)

In order to implement a consistent and transparent system that guarantees an effective product overview and traceability, important innovations in medical device law within Europe are about to be introduced. The new Medical Device Regulation (MDR) 2017/745/EU came into force in May 2017. After a 3-year transitional period up to May 2020, the MDR replaces Medical Devices Directive (MDD) 93/42/EEC and the Directive on active implantable medical devices 90/385/EEC. The MDR will be mandatory for all new products from May 26, 2020. The new requirements according to Annexes II and III of the MDR will result in increasing and exacting documentation and verification obligations. Despite the period available during the transitional period, we advise our clients to start preparing as soon as possible. Further details can be found in the download area under customer information about the MDR. 

TUV Poland