Regulation (EU) 2017/745 on Medical Devices applicable
Regulation (EU) 2017/745 on Medical Devices applicable since May 26, 2021
While Regulation (EU) 2017/745 came into force already on 25 May 2017, originally approved medical devices had a transition time of three years to meet new requirements. Since May 26, 2021, the new regulation is now applicable.
TBMED and the future OITB will help medical device developers to address the new requirements and receive CE marking which is particularly challenging for medical devices of class IIb and higher. The new directive reinforces key elements of the previous directive: supervision of notified bodies, conformity of assessment procedures, clinical investigation and clinical evaluation, vigilance an d market surveillance.
If you want to find out more, the EC provides an overview of the improvements here.