The MHRA revised its guidelines to make clear its stance and reflect its intention to extend the acceptance of CE-marked medical devices on the British market beyond June 30th, 2023. A statutory document that will give medical devices with CE Certification marking more time to be accepted on the British market has been put before Parliament.
This is intended to make the transition to a future, stronger regulatory regime for medical devices easier and will facilitate the continued, secure supply of medical equipment to Great Britain. The government will make sure that the new regulatory framework is implemented proportionately and gradually to promote system preparedness and reduce the risk of supply interruption for UK patients.
The updated framework will ideally start applying in July 2025. We have taken criticism from external stakeholders, including worries regarding the capacity of conformity assessment organizations, into consideration while establishing this schedule.
The EU extended the validity of some CE certifications in March 2023 as part of its efforts to allow manufacturers additional time to get certification for specific medical devices under the EU Medical Devices Regulation (EU MDR). The MHRA has provided guidelines about the acceptance of such certificates on the British market in order to give the sector more clarity.
The acceptability of CE-marked medical devices in the United Kingdom has been modified in accordance with MHRA Guidance. In order to assist in the successful implementation of the new regime, we will continue to collaborate with businesses, trade groups, and the larger medical device community. To assist the MedTech industry in interpreting the new regulatory standards, more information will be provided in conjunction with future regulatory revisions.
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Source: MHRA
