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BHTA responds to MHRA’s plans for future medical devices regulation, transitional arrangements

BHTA responds to MHRA’s plans for future medical devices regulation, transitional arrangements

The British Healthcare Trades Association, BHTA has issued its response to the Medicines and Healthcare Products Regulatory Agency, MHRA’s plans for the future of medical device regulations in the United Kingdom, UK.

On 26 June 2022, the MHRA published its response to its consultation on the future regulation of medical devices in the United Kingdom, as well as its plans to reform the regulation of medical devices following the UK’s exit from the European Union (EU).

The new regulatory regime is still scheduled to come into force on 01-Jul-23, however, the medical devices regulator has also introduced transitional arrangements, stating the measures are “to give industry enough time to adapt to the change.”

William Lee, Head of Policy and Compliance at the British Healthcare Trades Association, commented:

“The government has outlined transitional arrangements that should allow the supply of vital medical products to continue as the new regulatory regime takes effect.

“We are pleased that the government has acknowledged serious concerns raised by BHTA, other trade associations and industry, with regard to continuity of supply, shortage of conformity assessment bodies, hard-pressed MHRA resource, and the need for industry input into guidance on how the regime will operate.

“Many practicalities of the new regime remain to be clarified in implementation guidance – e.g. the roles and responsibilities of importers and distributors (see the consultation response, section 13.2, p. 35 ff) – and BHTA is reviewing the consultation in order to provide more detailed guidance in the coming days.”

The government has outlined transitional arrangements that should allow the supply of vital medical products to continue as the new regulatory regime takes effect.

  • General medical devices and in-vitro medical diagnostic devices (IVDs) that are CE marked under EU MDR or EU IVDR may continue to be placed on the GB market until either the certificate expires or for five years after the new regulations take effect (i.e. 01-Jul-28), whichever is sooner, with a view to reviewing this provision at the end of the five-year period. This will apply even if the certification/declaration of conformity is dated after the new regulations take effect
  • General medical devices and IVDs that are CE marked under EU MDD, EU AIMDD, or EU IVDD may continue to be placed on the GB market until either the certificate expires, or for three years (general medical devices) or five years (for IVDs) after the new regulations take effect (i.e. 01-Jul-28), whichever is sooner, with a view to reviewing this provision at the end of the five-year period

In both the cases above, the requirement that the product will need to have been lawfully placed on the Great Britain market by registering with the MHRA, with the certificate/declaration of conformity issued and the product registration completed before the new regulatory framework takes full effect will not be taken forward, in light of feedback received during the consultation.

As well, in both the cases above, two caveats that will apply to both categories of CE-marked devices covered by these arrangements:

  • 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

Finally, for general medical devices and IVDs that hold a valid certification/declaration of conformity to the UKCA standard before the new regime takes full effect, these products may be placed on the GB market until either the certificate expires or for three years after the new regulations take effect (general medical devices) or five years (IVDs).