The transitional period of the new EU Medical Device Regulation ends on May 26, 2021. The EU MDR thus replaces the current Medical Device Directive (93/42/EC) and the Directive on Active Implantable Medical Devices (90/285/EEC).
For medical device manufacturers who supply the market in the EU or plan to do so in future, means this, that products must meet the new EU MDR requirements. The transition to EU MDR is running and is preoccupying many medical device manufacturers with various issues and uncertainties.
A recurring question is, for example, how long medical devices, which are certified according to MDD, may still be placed on the market or how long they will be made available and put into service. This depends on the medical device class and the validity of the certificate.
For example, a class III medical device product, for which the validity of the certificate expires on February 15, 2024, may be placed on the market until that date. Making the device available and putting it into service would still be permitted until May 27, 2025. However, it should be noted that from May 26, 2021 onwards, nevertheless certain MDR requirements must have been implemented in order to continue to place this product on the market after May 26, 2021. These include the designation of a "responsible person", the implementation of the Postmarket Surveillance requirements and the implementation of further MDR requirements.
The expert team Medical Devices of gempex is the right contact person in all matters and brings along, not only many years of international experience, but also always the latest knowledge. No matter which class of medical device and no matter which topic. Learn more about the range of services Medical Device Q&R Compliance.