[Jun, 2022. London, UK] The Medicines and Healthcare Products Regulatory Agency (MHRA) has published its response to its consultation on the future of medical device regulation in the UK (26-Jun-22 press release and the full MHRA response Consultation on the Future Regulation of Medical Devices in the United Kingdom).
The new regulatory regime is still scheduled to come into force on 01-Jul-23, but – BHTA is pleased to note – 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. The government has outlined transitional arrangements that should allow the supply of vital medical products to continue as the new regulatory regime takes effect (see the consultation response, section 74.2, p. 153 ff):
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:
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).
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.
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William Lee, Head of Policy and Compliance at the British Healthcare Trades Association
With over 25 years of policy and advocacy experience, William Lee has spent much of his working life championing the needs of vulnerable communities at US & UK NGOs and governments. He is responsible for the research, development and dissemination of policy, strategy, parliamentary and technical information to BHTA members, and supports with the association’s important stakeholder engagement.
About the BHTA: Representing almost 400 companies in the healthcare and assistive technology industry, the British Healthcare Trades Association (BHTA) brings the industry together to help shape and improve the health and care of all. All BHTA members are committed to adhering to the Association’s Code of Practice – the only code in the industry approved by The Chartered Trading Standards Institute.
About the CTSI: The BHTA Code of Practice – the first for consumers in the healthcare industry – is approved under the Chartered Trading Standards Institute (CTSI)’s Consumer Codes Approval Scheme, ensuring all BHTA member companies trade ethically and professionally.
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