Regulatory Open Forum

Hello all,

Here is yet another question about the UKCA marking deadline. I have seen from some sources (notably, BSI: UKCA Marking Approval and Market Access in the UK) that medical devices may continue to be placed on the UK market until July 1 2024.

However, sources from the UK government still indicate that the UKCA marking deadline is July 1, 2023 (Regulating medical devices in the UK). Elsewhere, there is language that the UK government intends to extend acceptance of CE marked devices (Implementation of the Future Regulations). However, I am curious where it is actually stated by the UK government that this date has actually been extended to July 2024 so as to validate what BSI has posted in the link above.

Thanks!

Hello all,

Here is yet another question about the UKCA marking deadline. I have seen from some sources (notably, BSI: UKCA Marking Approval and Market Access in the UK) that medical devices may continue to be placed on the UK market until July 1 2024.

However, sources from the UK government still indicate that the UKCA marking deadline is July 1, 2023 (Regulating medical devices in the UK). Elsewhere, there is language that the UK government intends to extend acceptance of CE marked devices (Implementation of the Future Regulations). However, I am curious where it is actually stated by the UK government that this date has actually been extended to July 2024 so as to validate what BSI has posted in the link above.

Thanks!

Hello all,

Here is yet another question about the UKCA marking deadline. I have seen from some sources (notably, BSI: UKCA Marking Approval and Market Access in the UK) that medical devices may continue to be placed on the UK market until July 1 2024.

However, sources from the UK government still indicate that the UKCA marking deadline is July 1, 2023 (Regulating medical devices in the UK). Elsewhere, there is language that the UK government intends to extend acceptance of CE marked devices (Implementation of the Future Regulations). However, I am curious where it is actually stated by the UK government that this date has actually been extended to July 2024 so as to validate what BSI has posted in the link above.

Thanks!

Hi Anon

You are probably not alone in being slightly confused about this, because it has changed on a monthly basis and lots of elements have been presented as definitive facts, even by trusted organisations, without the caveat of the uncertainty associated with all of the announcements and drafts.

Current UK legislation says that all medical devices must be UKCA marked from 1 July 2023 onwards.

A draft amendment to that legislation introduces either a 5 or 7 year transition period for devices that are already CE marked with a valid CE certificate. This amendment does not alter the 30 June 2023 deadline. The 2024 date was announced by the MHRA (and then repeated by many) to accommodate the lack of progress with UKCA marking and all of the necessary moving parts, but it was announced/planned prior to the amendment of the EU MDR with Regulation (EU) 2023/607, and therefore it would not make sense to ignore the new EU transition periods for legacy CE marked devices. the 5 or 7 year period depends on the validity of the certificate, and will not allow for renewed certificates after July 2025.

The 'new' UK medical device regulations are tentatively scheduled to be released in draft form later this year, with a likely date of application in June 2025. I would assume that this new legislation will also include transition periods for those devices that have been UKCA marked under the current UK regulations, giving them time to transition to the new requirements.

I hope this helps.

Regards

Ed

Hello all,

Here is yet another question about the UKCA marking deadline. I have seen from some sources (notably, BSI: UKCA Marking Approval and Market Access in the UK) that medical devices may continue to be placed on the UK market until July 1 2024.

However, sources from the UK government still indicate that the UKCA marking deadline is July 1, 2023 (Regulating medical devices in the UK). Elsewhere, there is language that the UK government intends to extend acceptance of CE marked devices (Implementation of the Future Regulations). However, I am curious where it is actually stated by the UK government that this date has actually been extended to July 2024 so as to validate what BSI has posted in the link above.

Thanks!

Hello all,

Here is yet another question about the UKCA marking deadline. I have seen from some sources (notably, BSI: UKCA Marking Approval and Market Access in the UK) that medical devices may continue to be placed on the UK market until July 1 2024.

However, sources from the UK government still indicate that the UKCA marking deadline is July 1, 2023 (Regulating medical devices in the UK). Elsewhere, there is language that the UK government intends to extend acceptance of CE marked devices (Implementation of the Future Regulations). However, I am curious where it is actually stated by the UK government that this date has actually been extended to July 2024 so as to validate what BSI has posted in the link above.

Thanks!

Hello all,

Here is yet another question about the UKCA marking deadline. I have seen from some sources (notably, BSI: UKCA Marking Approval and Market Access in the UK) that medical devices may continue to be placed on the UK market until July 1 2024.

However, sources from the UK government still indicate that the UKCA marking deadline is July 1, 2023 (Regulating medical devices in the UK). Elsewhere, there is language that the UK government intends to extend acceptance of CE marked devices (Implementation of the Future Regulations). However, I am curious where it is actually stated by the UK government that this date has actually been extended to July 2024 so as to validate what BSI has posted in the link above.

Thanks!