2023-08-08 19:01:28
In our earlier news item today, we said that the UK Government had extended indefinitely its recognition of CE marking on medical devices placed on the market in Great Britain. It has been pointed out to us that this was incorrect and the indefinite extension does not apply to medical devices. We apologise for the error.
Recognition of CE marking on medical devices has been extended, but not indefiinitely. The timing when recogniton will lapse depends on the type of medical device. The timelines enablnig medical devices with a valid CE mark to be placed on the market are currently as follows:
- general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
- in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030, and
- general medical devices including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.