You may have seen that the UK Department for Business and Trade announced an “indefinite CE mark recognition beyond 2024 deadline”. This allows businesses to choose either UKCA or CE Marking to sell products in Great Britain.

Please note that this does not apply to medical devices and IVDs.

The UK MHRA issued a clarifying statement that medical devices and IVDs are subject to separate legislation and CE Marking has a restricted allowance period in Great Britain. i.e., the UK Department of Business and Trade’s announcement only applies to non-medical products. For example, those CE Marked under the Machinery or Low-Voltage Directives.

As Casus had previously reported, the timelines for CE Marked devices in Great Britain are:

• MDD/AIMDD CE Marked legacy devices – until 30 June 2028 or the device no longer qualifies as a legacy device under MDR Article 120
• IVDD CE Marked legacy devices – until 30 June 2030 or the device no longer qualifies as a legacy device under IVDR Article 110
• MDR/IVDR CE Marked devices – until 30 June 2030 or the CE Certificate expires

For the full overview of CE Marking acceptance in Great Britain, please read: UK MHRA Announcement: New Dates for UK Regulation & CE Marking