CE marked medical devices to benefit from indefinite recognition in the UK
The MHRA has announced that patients across Great Britain will continue to have access to medical devices and in vitro diagnostic devices (IVDs) “on a long term basis”.
In practice this means that medical
Deadline of 28 November 2026 to register legacy devices in Eudamed
Where a legacy medical device was placed on the EU market before 28 May 2026 but units of the device continue to be supplied the device must be registered with Eudamed by 28 November 2026.
A new draft of IEC 62304 has been created
A draft of Edition 2 of IEC 62304 has been produced. IEC 62304 Medical device software — Software life cycle processes establishes life cycle requirements for development of medical device software.
Although it is not
Timetable for EMA advice to medical device manufacturers
The European Medicines Agency (EMA) has published its timetable concerning the Agency’s procedure for providing advice to medical device manufacturers. This advice procedure, which is based on Article 54 of the Medical Devices Regulation (MDR), is intended to