Seminare und Veranstaltungen
Introduction to the EU Medical Device MDR regulation
The new Medical Device Regulation MDR encompasses medical devices covered by the General Medical Device MDD Directive as well as all products covered by the AIMDD, the purpose of which is to ensure better protection of public health and patient safety.
On May 5, 2017, the Official Journal of the European Union published the REGULATION (EU) 2017/745 (MDR) for Medical devices. The purpose of this regulation is to ensure better protection of public health and patient safety. The MDR will replace the Directives 90/385/EEC and93/42/EEC (Active Implantable Medical Devices Directive). In accordance with the requirements of MDR Article 123, the MDR came into effect on May 26, 2017 and replaced MDD (93/42/EEC) and AIMDD (90/385/EEC) on May 26, 2020. From the date of application, all new medical devices placed on the market in the EU must comply with the requirements of the MDR.
After the implementation of MDR, it is still possible to apply for CE certificates in accordance with MDD and AIMDD and maintain the validity of the certificates during the three-year transition period. CE certificates issued by NB during the transition period continue to be valid in accordance with Article 120 clause2, but are valid for no more than 5 years from their delivery date and expire on 27 May 2024.