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Government Publishes Consultation Response on the Future Regulation of Medical Devices in the UK. 

 

This response document can be found on this Link

 

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.

 

The Key Take Aways Include :

 

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.

 

While this consultation answers some of the top queries, it also opens pandora's box for new requirements and deadlines. Our Appeal states that the Manufacturers should start focusing on an early compliance strategy. Waiting till the last minute for the enforcement to the transition will only result in product recalls, affecting the care process of the end users and patients. 

 

Our Regulatory Team is here to assist you with all the Regulatory Affairs requirements in the EU, UK, USA and the Rest of the World!

 

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