On June 16, 2023, the United Kingdom (UK) issued updated guidance extending the acceptance of Conformité Européenne (CE) marked devices in Great Britain beyond June 30, 2023.
The new timelines are 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 EU medical devices regulation (EU MRD) 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.”
Link to the UK Guidance “Regulating medical devices in the UK” can be found here Regulating medical devices in the UK - GOV.UK (www.gov.uk)
Link to the “Implementation of the Future Regulations” can be found here Implementation of the Future Regulations - GOV.UK (www.gov.uk)
