BHTA and BIVDA respond to consultation on UK medical device regulation

The Medicines and Healthcare Products Regulatory Agency has published its response to your query on the future of medical device regulation in the UK.

The government says the reforms will apply to medical devices such as hearing aids, X-ray machines and insulin pumps; new technologies such as smartphone apps and Artificial Intelligence (AI); as well as certain cosmetic products such as dermal fillers.

The government says the new measures will involve:

  • Strengthen the powers of the MHRA to act to keep patients safe, giving the public and patients greater assurance of both the performance and safety of higher risk medical devices, such as those to be implanted.
  • Increase the reach and scope of regulation to respond to the needs of the public: improve systems that already exist to better protect users of medical devices and certain cosmetic products and provide greater assurance of their performance and safety.
  • Address health disparities and mitigate inequities identified throughout the development and use of medical devices: Mitigate inequities in medical devices, ensuring they work as intended for diverse populations. The government has launched a review on potential equity issues in the design and use of medical devices to address health inequalities and will update it in due course.
  • Make the UK a hotbed for innovation and the best place to develop and introduce innovative medical devices, ensuring that the new regulatory framework encourages responsible innovation so that patients in the UK can better access the most advanced medical devices to satisfy your needs.
  • Setting world-leading standards and building the new UKCA brand: transforming a new certification seal, replacing the CE mark, into a trusted mark signifying global safety, health and environmental protection standards for medical device products have been met . This, in turn, will boost the MHRA’s global reputation and growing partnerships with other regulators.

Health and Social Care Secretary Sajid Javid said: “Now that we have left the EU, these new changes will allow innovation to flourish and ensure that UK patients are among the first to benefit from technological advances.

“We can now introduce some of the world’s strongest security measures for medical devices to ensure patients are protected.”

Dr. June Raine, Executive Director of the MHRA, added: “As a regulator, our priority is to protect patients and the public and to make it easier and faster for patients to access the medical devices and treatments they need.

“We would like to thank everyone who has shared their views as part of this consultation, including patients, industry and the healthcare sector.

“We all know the importance of medical devices in our daily lives and their input has been invaluable in helping us shape future regulations and ensure continued safety and access for patients.”

Regulations will keep pace with new and emerging technologies, for example software and artificial intelligence (AI) that are increasingly being used in areas such as screening and diagnosis, as well as chronic condition management and drug development. new treatments. The new measures will ensure that innovations like these are held to the same standards as medical devices.

The MHRA will phase in the new requirements with transitional arrangements, to give the industry enough time to adjust to the change, with the regulatory changes coming into effect in July 2023. The transitional arrangements outlined include:

  • General medical devices and in vitro medical diagnostic (IVD) devices that are CE marking under EU MDR or EU IVDR may continue to be placed on the GB market until the certificate expires or for five years after the entry into force of the new regulations (ie, 01-Jul-28), whichever comes first, 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 entry into force of the new regulation.
  • General medical devices and IVDs that are CE marking under EU MDD, EU AIMDD or EU IVDD may continue to be placed on the GB market until the certificate expires, or by Three years (general medical devices) or five years (for IVD) after the entry into force of the new regulations (i.e. 01-Jul-28), whichever is earlier, with a view to reviewing this provision at the end of the five-year period

In both of the above cases, the requirement that the product must have been legally placed on the market in Great Britain by registration with the MHRA, with the certificate/declaration of conformity issued and product registration completed before the new framework regulation enters into force will not be carried out, in light of the comments received during the consultation.

Additionally, in the two cases above, two caveats will apply to both categories of CE marked devices covered by these agreements:

  • 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 met for all products benefiting from the transitional provisions.

William Lee, head of policy and compliance at the British Healthcare Trades Association, said: “The government has outlined transitional arrangements that should allow the supply of vital medical products to continue as the new regulatory regime comes into effect.

“We are pleased that the government has recognized the serious concerns raised by the BHTA, other trade associations and industry, regarding continuity of supply, the shortage of conformity assessment bodies, the struggling MHRA resource and the need for input. from the industry on guidance on how the regime will operate.

“Many practical aspects of the new regime remain to be clarified in the implementation guidance, for example the roles and responsibilities of importers and distributors (see response to query, section 13.2, p. 35 and following), and BHTA is reviewing consultation to provide more detailed guidance.”

The British In Vitro Diagnostics Association (BIVDA) welcomed the publication of the consultation, saying it appears the UK will largely align with the EU regulatory path, with a number of UK-specific requirements.

BIVDA chief executive Doris-Ann Williams said: “It is a relief for the industry to have clarity on what to expect from IVD regulations in the UK. BIVDA looks forward to continuing to work with MHRA in the future and providing support to our members where necessary to navigate this new chapter.”

BIVDA Regulatory Affairs Manager Ashleigh Batchen added: “This is a much-needed step to enable industry and other stakeholders to understand what is required of them under the new Regulations. MHRA has done a fantastic job of providing this level of clarity, and we will work with members to ensure they have a good understanding of these requirements.”

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