New timelines for CE marked medical devices to continue to be placed on the Great Britain market!

The UK government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023!

Subject to Parliamentary approval, the UK plan is to to introduce legislation before 30 June 2023, which will establish new significant timelines for CE marked medical devices to continue to be placed on the Great Britain market:

• general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU 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 (EU 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 the sooner of expiry of certificate or 30 June 2030.

Here is the link to the updated Implementation of the Future Regulations.

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