BHTA and BIVDA respond to consultation on UK MDR

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 like dermal fillers.

The government says the new measures will involve:

• Strengthening the MHRA’s powers to act to keep patients safe – giving the public and patients greater assurance on both the performance and safety of the highest-risk medical devices, such as those which need to be implanted.
• Increasing the scope and extent of regulation to respond to public need – enhancing systems that are already in place to better protect users of medical devices and certain cosmetic products and providing greater assurance of their performance and safety.
• Addressing health disparities and mitigating identified inequities throughout medical devices development and use – mitigating against inequities in medical devices, ensuring they function as intended for diverse populations. The government has launched a review into the potential equity issues in the design and use of medical devices to tackle health inequalities and will update in due course.
• Making the UK a focus for innovation, and the best place to develop and introduce innovative medical devices – ensuring the new regulatory framework encourages responsible innovation so that patients in the UK are better able to access the most advanced medical devices to meet their needs.
• Setting world-leading standards and building the new UKCA mark – transforming a new stamp of certification, replacing the CE mark, into a trusted brand that signifies global safety, health and environment protection standards have been met for medical device products. This will in turn boost the MHRA’s global reputation and growing partnerships with other regulators

Health and social care secretary Sajid Javid said: “Now we have left the EU, these new changes will allow innovation to thrive and ensure UK patients are among the first to benefit from technological breakthroughs.

“We are now able to introduce some of the most robust safety measures in the world for medical devices to ensure patients are protected.”

Dr June Raine, chief executive of the MHRA, added: “As a regulator, our priority is to protect patients and the public and make it easier and quicker 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 day-to-day lives and your input has been invaluable in helping us to shape the future regulations and ensuring continued patient safety and access.”

The regulations will keep pace with new and emerging technologies, for example software and artificial intelligence (AI) which are increasingly being used in areas such as screening and diagnosis, as well as the management of chronic conditions and developing new treatments. The new measures will ensure innovations such as these are subjected to the same standards as medical devices.

The MHRA will gradually phase in the new requirements with transitional arrangements, to give industry enough time to adapt to the change, with the regulatory changes due to come into force in July 2023. The transitional arrangements outlined 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 (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

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 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.”

The British In Vitro Diagnostics Association (BIVDA) welcomed the publication of the consultation, saying it appears that the UK will be largely aligning to the EU regulatory route, with several UK-specific requirements.

BIVDA chief executive officer, Doris-Ann Williams, said: “It is a relief for industry to have clarity on what can be expected on the IVD regulations in the UK. BIVDA look forward to continuing to work with MHRA going forward and provide support to our membership where needed in navigating this new chapter.”

BIVDA regulatory affairs manager, Ashleigh Batchen, added: “This is a much-needed step in allowing industry and other stakeholders involved to understand what is required of them within the new Regulation. 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.” Med-Tech Innovation