Medical equipment bearing a European CE mark will now be accepted on the British market indefinitely, meaning patients will retain access to medical devices and in vitro diagnostic (IVDs) already approved in Europe, the UK government has confirmed.
The decision, which follows a public consultation this year that ran from 16 February to 10 April, means the UK will not require an additional approval route for devices already approved for the EU market. An additional approval route via domestic pathways had previously been considered post-Brexit.
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More than 90% of medical devices registered for use in Britain currently carry a CE mark, according to the government, meaning their assessment and approval in Europe has been recognised across Britain.
Continuing to recognise devices in this way will help maintain safe, uninterrupted access to the treatments and technologies that patients and the NHS rely on, the government stated. Meanwhile, indefinite recognition of the CE mark fits alongside the UKCA marking route, which continues to operate as the domestic approval pathway for devices placed on the market in Britain, it added.
Lawrence Tallon, CEO of the Medicines and Healthcare products Regulatory Agency (MHRA), said: “This decision gives patients, the NHS and industry the long-term certainty they need on access to medical devices. By continuing to recognise CE marked devices, we’re ensuring that patients across Great Britain maintain uninterrupted access to the medical technologies they depend on.
Tallon added that the MHRA will continue to oversee the safety of every device on the UK market, and remains committed to working closely with international partners to “identify and act on safety concerns quickly.”
Following the UK’s departure from the European Union in 2016, as a means of moving away from European legislation, makers of devices or IVDs already bearing a CE-mark were given a timeline to transition to the UK’s own UKCA regime to continue marketing their products in the UK.
Under the original plans, makers of medical devices CE-marked under the old European medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) could be placed on the British market until 30 June 2028, with the same cutoff for IVDs tagged under the previous EU regulatory regime. Meanwhile, for devices compliant with the EU’s two newer regulatory regimes, the EU medical device regulation and in vitro diagnostics regulation (MDR/IVDR), the cutoff period was set at 30 June 2030. The decision to accept CE marked medical devices on a long-term basis puts an end to those stipulations.
Steve Lee, executive director, regulation at the Association of British HealthTech Industries (ABHI), commented: “Regulatory predictability and avoiding unnecessary duplication are fundamental to industry investment decisions, which ultimately determine how quickly patients can access new technologies. Long-term recognition of CE marking is therefore a significant and welcome decision, providing much-needed certainty for manufacturers, safeguarding patient access and strengthening the UK’s position as an attractive and competitive market for healthtech.”
