New legislation designed to usher in clearer requirements for improving medical device safety has begun its journey through parliament – but overall clarity is still lacking, says a regulatory expert

Back in January, the Medicines and Healthcare products Regulatory Agency (MHRA) published its roadmap towards delivering Medical Device Regulatory Reform and strengthening patient safety across Great Britain.

The MHRA – responsible for regulating all medicines and medical devices in the UK – has since confirmed that the new Reform framework will be introduced through a series of Statutory Instruments (SI), replacing the UK Medical Devices Regulations 2002 and providing greater certainty for manufacturers.

The first SI focused on Post-Market Surveillance (PMS) was laid in Parliament on Monday and sets out initial steps.

The MHRA said that, through the introduction of “clear, risk-proportionate requirements”, this new legislation “will build on measures already introduced to improve patient safety, facilitating greater traceability of incidents and reporting trends”.

The agency insisted: “We are committed to delivering a framework of regulatory reform that encourages innovation and growth in life sciences and which, in turn, brings huge benefits to patients.”

However, with the SI proposing a six-month implementation period once Parliamentary processes have been concluded, the advance Post-Market Surveillance requirements may eventually become law in summer 2025 at the earliest.

While welcoming the parliamentary progress made, Head of Regulatory Affairs at InnoScot Health, Elaine Gemmell insists that the timing of the most important changes – or ‘core regulations’ as they have become known – must be more transparent.

She said: “PMS covers the actions which manufacturers need to take to monitor and report on devices once they are on the market, so the commencement of this SI through parliament is undoubtedly positive news with safety placed firmly to the fore.

“But with the MHRA originally planning to put it to MPs and Peers back in May, it is clearly now behind schedule, meaning a likely knock-on effect for the core regulations.

“We therefore now require greater clarity on the renewed timeline for the bulk of the updates which will eventually underpin the wider future regulatory regime.”

Speaking on the PMS SI, MedTech Regulatory Reform Lead and Chief Officer at MHRA, Laura Squire stated: “These new measures are expected to further reduce adverse incidents by ensuring manufacturers identify and address issues earlier and reduce the time for corrective actions to be taken.

“It also benefits innovation and growth of the sector, with the collection of real-world data helping manufacturers to further improve existing products.”

The MHRA added that “the explosion of innovation in health technology in recent years has the potential to bring transformative approaches to healthcare” and the new regulations will “provide the necessary oversight to ensure that this progress is made as safely as possible”.

Comprehensive guidance to support manufacturers with implementation and compliance will be published once the Parliamentary process has been concluded, the agency said.

Elaine continued: "Put simply, the MHRA now has an ambitious, challenging timetable ahead."