Medtech body looks to UK regulator to streamline regulatory burdens

The Medicines and Healthcare products Regulatory Agency (MHRA) was called on to facilitate “internationally aligned reliance pathways” in an open letter signed by Edmund Proffitt, chair of the UK MedTech Forum. The forum comprises different UK medtech trade associations – such as the Association of British HealthTech Industries (ABHI) and consumer healthcare body PAGB – that each represent manufacturers of medical devices and in vitro medical devices (IVDs).

In his open letter to the MHRA (3-page / 253KB PDF), Proffitt said: “We call for the establishment of a proportionate, streamlined, reliance-based pathway for premarket approvals from trusted international regulators, such as the US FDA, Health Canada and TGA, Australia. Such pathways should reflect international best practices, reduce unnecessary duplication, and ensure proportionate oversight – particularly for SMEs and novel technologies, including software and AI-driven medical devices and IVDs.”

Proffitt said the MHRA is well placed to “take a leadership role in international harmonisation” and in turn to “support patient safety, data exchange and market access for both new and proven healthtech products globally”, owing to its membership of the International Medical Device Regulators Forum. He said UK industry would be willing to help the regulator develop and test “new regulatory mechanisms”.

Catherine Drew of Pinsent Masons, who specialises in regulatory matters in life sciences, said: “We have seen the MHRA implement international reliance-based approval pathways in the pharmaceutical space and it seems that the proposals of the Forum in the medical devices space would be similarly welcomed as improving efficiency for both the MHRA and manufacturers and reducing barriers to entry, thereby increasing access for patients.” 

The letter further called on the MHRA to introduce “an indefinite and near-automatic recognition mechanism” for CE-marked devices certified under EU medical devices legislation, to enable those products to be more easily put on the market in Britain.

This recognition mechanism would remove duplicative premarket assessments and reduce regulatory burdens and costs for medical device manufacturers, as well as “safeguard patient access to a wide range of safe, effective, and high-quality medical devices and diagnostics”, Proffitt said. He cited industry concerns captured in surveys last year which he said convey “growing concerns around regulatory costs and delays” and added that those factors are “affecting market viability and innovation pipelines across the UK and the EU”.