MHRA Responds to Trade Association Concerns with Transitional Guidance

By MedTech Intelligence Staff
June 29, 2022


• Categories: 05-Quality/Regulatory, MDR/IVDR, RC - EU MDR and IVDR, Regulatory

Both the British Healthcare Trades Association (BHTA) and the British In Vitro Diagnostic Association (BIVDA) have published statements welcoming the U.K. Medicines and Healthcare products Regulatory Agency (MRHA) response, published on June 26, to industry concerns and input regarding implementation of future regulation of medical devices in the UK. The new regulations are scheduled to go into effect on July 1, 2023.

The BHTA noted 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 resources and the need for industry input into guidance on how the regulations will operate. The government has outlined transitional arrangements that should allow the supply of vital medical products to continue as the new regulatory regime takes effect.

The transitional arrangements include:

• 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 (July 1, 2028), 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, 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.

In addition, in both the cases above two caveats 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

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).

“This is a much-needed step in allowing industry and other stakeholders involved to understand what is required of them within the new Regulation” said Ashleigh Batchen, regulatory affairs manager, BIVDA. “MHRA have done a fantastic job at providing this level of clarity, and we will work with members to ensure they have a strong understanding of these requirements.”