Confirmation that CE-marked medical devices will be indefinitely permitted on the UK market is not only a major boost to both patients and MedTech growth aims, but also finally places the UK on a much more competitive international footing

That’s the view of regulatory specialist Elaine Gemmell of InnoScot Health — a key partner in realising healthcare innovation ambitions — following the announcement that Scotland, England, and Wales can access medical devices bearing EU CE-marking on the Great Britain market in the long-term.

At a stroke, the move has removed significant administrative complexity from what Elaine calls “an incredibly imbalanced situation” for around 90% of medical devices and in vitro diagnostic devices (IVDs) with dual approval through both the UKCA marking route and EU CE-marking route not required beyond 2030.

With the UK government and Medicines and Healthcare products Regulatory Agency (MHRA) confirming indefinite recognition of the EU CE mark yesterday (21 October), InnoScot Health’s Head of Regulatory Affairs believes longer-term uncertainty has ended, in turn boosting the competitive ambitions of leading innovators.

Elaine says the “hugely significant” move will avoid MedTech manufacturers’ requirement for frustrating additional approvals while helping to maintain consistent supply and patient access to medical devices and IVDs — all of which she considers to be both “positive and progressive”.

The long-awaited decision is a response to the MHRA’s eight-week, single-issue consultation which closed in April 2026 — receiving more than 1,000 responses from patients, healthcare organisations, industry and others — with indefinite recognition of EU MDR and EU IVDR-compliant devices widely considered to be the key proposal.

Elaine said: “I believe this is a hugely significant, and very necessary step which creates a closer regulatory relationship with the EU. Indefinite recognition of the overwhelming percentage of CE-marked medical devices in Great Britain reduces the complexities and fragmentation which had combined to create deep uncertainty over the last few years.

“Now, it is no longer the case that general medical devices compliant with EU Medical Devices Directive (EU MDD) or Active Implantable Medical Devices Directive (EU AIMDD) guidelines can be placed on the market only until then end of June 2028.

“It means that, for the foreseeable future, devices and IVDs have been assessed and approved for the European market and the same approval is also recognised to provide access to the Great British market.

“The duplication caused by trying to achieve approval through two separate regulatory regimes was unsustainable, so now we have a markedly more stable environment which fosters innovation and investment and creates a steady flow of medical devices and IVDs.

“That is both positive and progressive for strategically igniting market fortunes through the ability to attract greater international investment and consistently accelerate the delivery of safe, innovative treatments and diagnostics to patients.”

She added: “With the MHRA only just confirming that it has uniformly accepted 44 recommendations made by the independent National Commission into the Regulation of AI in Healthcare, it is clear that many opportunities for innovation are being accounted for going forward.”

Chief Executive of the MHRA, Lawrence Tallon, said: “This decision gives patients, the NHS and industry the long-term certainty they need on access to medical devices.”