The Association of British HealthTech Industries (ABHI) has reassured its members that a UK product safety mark to replace the CE mark in the event of a no-deal Brexit will not apply to medical devices.
In the UK, all medical devices are subject to EU legislation, which requires manufacturers to place CE marks on their products to show compliance to applicable standards.
Earlier this week, the government published the design for the UKCA marking, which would replace the CE marking for certain products if the UK leaves the EU without a deal.
However, according to the Department for Business, Energy and Industrial Strategy (BEIS), the UKCA marking will not be used for medical devices.
“We have been informed by the Office for Life Sciences that nothing for medical devices is changing regarding the use of the CE mark in a no deal,” ABHI wrote in an announcement to its members.
If there is no deal, the UK’s participation in the European regulatory network for medical devices will end, and the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK market that are currently undertaken through the EU system.
Last month, the MHRA published updated guidance on the regulation of medicines, medical devices and clinical trials in a no-deal Brexit scenario.
It states that for a limited time period, devices that have a CE mark from a notified body (NB) based in the UK or an EU country will continue to be recognised by UK law and be allowed to be placed on the UK market.
After 29 March, all devices will have to be registered with MHRA before being placed on the UK market.
The future process for bringing a medical device onto the UK market will be subject to consultation, the MHRA guidance says.
"Work remains to ensure the continued supply of medical technologies to patients"
ABHI technical and regulatory director, Phil Brown, told MobiHealthNews the trade association welcomed the MHRA guidance and the “government's ambition to maintain regulatory alignment on day one”.
But he added: “Whilst this is a positive step, work remains to ensure the continued supply of medical technologies to patients.
“For this reason, we will continue to engage with the government, MHRA and stakeholders within Europe, to make sure disruption to supply is limited.”
ABHI is in dialogue with its European partners to ensure “that negotiators on both sides are aware and understand potential issues", Brown said.
A spokesperson for the British Standards Institution, the UK’s national standards body said:
“Regardless of the outcome of Brexit, our membership of international and European standards organisations will ensure British industry, consumers and other stakeholders continue to be represented.”