A regulatory expert has urged medical device manufacturers to immediately utilise fresh guidance on post-market surveillance to remain ahead of enhanced requirements expected this summer

Head of Regulatory Affairs at NHS Scotland partner InnoScot Health, Elaine Gemmell believes familiarisation is key — particularly amid an explosion of innovation in health tech in recent years — making for what she calls “an essential preparatory step” for manufacturers.

Last week, the Medicines and Healthcare products Regulatory Agency (MHRA) published a suite of guidance to help ensure that the amended Post-market surveillance (PMS) regulation for medical devices in Great Britain is able to come into force on 16 June as smoothly as possible.

The changes to the regulation are intended to improve the safety of medical devices — including in vitro diagnostics (IVD) and active implantable devices — while providing certainty for manufacturers.

Part of wider regulatory reform, the amended regulation will, MHRA says, “introduce clearer and more risk-proportionate PMS requirements”.

Elaine said: “Never more have we needed transformative approaches to healthcare for better patient outcomes, and new medical device breakthroughs are a key driver in realising that goal.

“But consultation responses have been consistent around such innovation — the introduction of clearer, more robust post-market surveillance requirements are necessary to improve safety for both patients and public alike, and in greater alignment with international standards.

“In response, we now have an important amendment arriving in June and manufacturers are in a great position to prepare in advance thanks to the publication of fresh guidance.

“I would urge them to take advantage of that opportunity right away to better understand their obligations, particularly when you consider that the requirements vary based on risk levels posed by devices to patients.”

Key elements of the changes to PMS legislation for manufacturers of medical devices include:

• Shorter timescales for investigation and reporting of serious incidents
• Summary reporting to enable identification of safety issues earlier
• Retention of relevant documents and for them to be provided on request to the regulator
• Enhanced data collection
• Clearer risk mitigation obligations when monitoring performance in real-world conditions

Elaine added: “This is complex legislation to navigate in many respects, and it is vital that manufacturers prepare as early as possible to help ensure their devices continue to meet required standards of safety and performance. Feedback on the guidance is also welcomed by MHRA, offering an opportunity for additional enhancements prior to 16 June.”

Laura Squire, MedTech Regulatory Reform Lead and Chief Officer at the MHRA, said the new PMS regulations will allow the regulator “to act swiftly when needed to reduce potential harm” and would “enable not only the MHRA, but the whole health system, to better protect patients”.

MHRA insists it will mean “a strong foundation for patient safety” is in place before future measures “allow patients to benefit more quickly from some types of medical devices that have already been approved for use in other countries”.