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Topic : Regulation Type : Briefing

The response to the consultation on the future regulation of medical devices, including in vitro diagnostic medical devices, has now been published. 

This document sets out what the MHRA has heard, the government’s response to the consultation, and the MHRA’s next steps for the implementation of a transformed regulatory framework for medical devices in the UK.

Of primary importance to members, and the wider HealthTech industry, is the question of transition to new arrangements by 1st July 2023. Questions around Conformity Assessment Body capacity and process readiness have been prominent in our discussions with the MHRA, with both topics making the deadline practically impossible to meet without the risk of product shortages. We are pleased, therefore, to see that these concerns have been addressed. 

Products that are CE marked under the MDR or IVDR can continue to be placed on the market until either the certificate expires or for five years after the new regulations take effect, whichever is the sooner. This will apply even if the certification/declaration of conformity is dated after the new regulations take effect. Products certified to this standard will be permitted to be placed on the Great Britain market for up to five years from the date on which the new regulatory framework takes effect, with a view to reviewing this provision at the end of the five-year period.

For medical devices that hold a CE mark issued under the MDD, AIMDD and IVDD before the new regulations take effect, these can now be placed on the market until the certificate expires or for an additional three years for general medical devices, and five years for IVDs, whichever is sooner. 

For products that hold a valid certification/declaration of conformity to the UKCA standard, before the new regime takes full effect, transition arrangements will allow products to be placed on the market until either the certificate expires or for three years after the new regulations take effect in the case of general medical devices or five years in the case of IVDs, whichever is sooner.

The two caveats that apply to the transitional arrangements are: 

• Devices that are subject to significant changes in design or intended purpose will be excluded from these provisions.
• All post-market requirements applicable to the new regulatory framework must be complied with for all products which benefit from the transitionary arrangements.

We are currently studying the consultation response in detail and will issue further analysis in due course.

We have spoken to the MHRA over the weekend (25th/26th June 2022) and are looking forward to engaging further via planned focus groups over the coming months, which are intended to help draw up guidance to accompany the UKCA regulations. 

Ends

If you have any questions related to the consultation response, please write to:

• Phil Brown, Director, Regulatory & Compliance: phil.brown@abhi.org.uk
• Steve Lee, Director, Diagnostics Regulation: steve.lee@abhi.org.uk 

Or for communications queries:

• Jonathan Evans, Associate Director, Communications: jonathan.evans@abhi.org.uk