MHRA plans wave of MedTech regulation after consultation shows support for reform

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to introduce a wave of regulations to reclassify medical devices, strengthen postmarket surveillance and otherwise revise its approach to medtech after seeing support for reform in the 891 responses to its 2021 consultation.

MHRA proposed a slate of medtech reforms considering the Cumberlege Review and the opportunity presented by Brexit. The proposals were intended to improve patient safety, increase transparency, more closely align the UK with international practices and make MHRA’s regulations more flexible, responsible and proportionate (RELATED: MHRA floats overhaul of medical device regulation in public consultation, Regulatory Focus 20 September 2021).

After feedback, the UK government has published its response.

“MHRA received strong support for proposals that will improve patient safety and safeguard public health, for example, through modernizing the scope and classification rules of medical devices to deliver improvements in the safety of all medical devices. It also raised points around identified inequities within clinical investigations,” said Sajid Javid, secretary of state for health and social care. “MHRA will look to address these points within the regulations and supplementary guidance to support this review.”

Seventy percent of the respondents backed MHRA’s proposed changes to the rules for classifying medical devices. Specific details received pushback, for example over the burden and costs of changes to active implantable devices.

MHRA will also work to strengthen postmarket surveillance after finding broad support. The consultation found 93% of respondents agree manufacturers should implement a postmarket surveillance system based on a post-market surveillance plan, “which collates and utilizes information from a range of sources.” There was also widespread support for the regulations providing a detailed outline of what the plan should address and what postmarket clinical and performance follow-up should include.

The government response also establishes transitional arrangements for the changes. One key question going into the consultation was how to ensure a smooth transition to the new regulatory framework. After reviewing the feedback, the government plans to introduce transitional arrangements for both UK Conformity Assessed (UKCA) and CE marked medical devices.

For UKCA marked devices, the government plans to allow products to be placed on the market until the certificate expires or for three years after the regulations take effect, for medical devices, or for five years, for in vitro diagnostics (IVDs). If the certificate expires before the three or five-year window is up, the transitional arrangements will end. The government has proposed similar arrangements for devices and IVDs with CE marks. Sponsors of clinical trials that straddle the old and new regulations will not need to reapply to MHRA but will need to comply with the new reporting requirements. RAPS.org