The UK Government have published an amendment to the UK Medical Device Regulations 2002. Notably, this is the first statutory instrument shaping the new UKCA requirements in Great Britain.
BIVDA have provided our initial understanding of this text below. Please consult your own legal teams before acting on any of this advice, as it is our own interpretation. We are hoping to receive additional guidance shortly from MHRA to give further context to this information.
Previous understanding
Date of application: 1 July 2023, however, MHRA issued a statement in October 2022 indicating this would be amended to take effect from 1 July 2024.
Transition for UKCA UK MDR products: 5-year transition period, as long as UKCA certificate or declaration of conformity was dated prior to new date of application [communicated as 1 July 2024], or until expiry of the certificate.
Transition for CE IVDD products: 5-year transition period, as long as CE certificate or declaration of conformity was dated prior to new date of application [communicated as 1 July 2024], or until expiry of the certificate.
Transition for CE IVDR products: 5-year transition period; date of CE certificate or declaration of conformity does not have any impact on eligibility of transition window, as long as the certificate or declaration of conformity is valid in the EU [communicated as 1 July 2024].
New understanding
Date of application: Unknown – the new statutory instrument removes the current date of application (1 July 2023) but does not indicate a replacement date. Associated guidance indicates a possible date of 1 July 2025.
Transition for CE IVDD products*: Can continue to utilise CE certificate or declaration to place on the GB market until 2030, as long as CE certificate or declaration of conformity was dated prior to new date of application [unknown date], or until expiry of the certificate.
Transition for CE IVDR products: Date of CE certificate or declaration of conformity does not have any impact on eligibility of transition window, as long as the certificate or declaration of conformity is valid in the EU – can be placed on the GB market until 2030, or until expiry of the certificate.
*For CE IVDD products which do not currently need conformity assessment from a Notified Body and will not require assessment from a Notified Body under the IVDR, these transition timelines do not apply, and the product will need to comply with the new UKCA regulations from the date of application.
NOTE: The transitional arrangements for CE IVDD and CE IVDR are dependent on the EU documentation being valid. If you have a product which is being up-classified under the EU IVDR and you are taking advantage of the transitional arrangements, the ‘expiry date’ of your CE IVDD certificate or declaration of conformity will be the IVDR transitional date of the new classification at the latest.
Example: General IVD under IVDD, considered to be Class C under IVDR – the declaration of conformity for this product will expire on 26 May 2026. From 27 May 2026, an IVDR certificate or a new UKCA certificate will be needed to place on the GB market.
Next steps
This new legislation should take effect from 30 June 2023, in time to replace the existing UKCA requirements. It has been laid before the House of Commons and the House of Lords, and will now go through debates in each chamber. If it is approved, it will pass into law.
Such a process would normally be expected to take 2-4 weeks to complete, but this may be affected by the upcoming bank holidays.
MHRA have also updated guidance documents to be reflective of this change, including Implementation of the Future Regulations and Regulating medical devices in the UK. Interestingly, both guidance documents suggest that the date of application will be 1 July 2025, despite this not being within the legislation itself.
BIVDA will be hosting a webinar in the coming weeks to discuss this content in more detail. Notice of this will go out to the UKCA sub-group; if you are not a member of the UKCA sub-group and wish to be, please contact Ashleigh to be added.
Please note: BIVDA is not in a position to give definitive advice on matters concerning the law and you should always contact your legal advisers on such matters. BIVDA does not accept any liability for any errors, omissions or misleading or other statements in this communication whether negligent or otherwise.
