The EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR). The new arrangements recognise the challenges in capacity across notified bodies.
This is an update to our previous announcement in February 2023.
Key changes include:
- Extension of the transitional period for higher-risk devices (class III and certain class IIb implantables), such as pacemakers, to comply with EU MDR requirements until 31 December 2027, subject to certain conditions (including requirements for post-market surveillance, quality management systems, and engagement with notified bodies).
- Extension of the transitional period for medium and lower-risk devices (other class IIb devices, class IIa, class Im, Is and Ir devices), such as syringes, to comply with EU MDR requirements until 31 December 2028, subject to certain conditions (including requirements for post-market surveillance, quality management systems, and engagement with notified bodies)…
