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Firms Using Three UK Notified Bodies Could Be Forced To Suspend Certificates Post-Brexit

 
• By Amanda Maxwell

There are a total of four UK notified bodies. It doesn't appear that three of them will be ready in time for a no-deal Brexit, likely forcing device manufacturers who use the services to suspend products from the market while the companies change notified bodies, one attorney says.

Brexit concept

Manufacturers who rely on one of three notified bodies based in the UK and who have not yet taken steps to obtain certificates from an alternative notified body are unlikely to obtain a new certificate in time for the March 29 Brexit deadline, when a no-deal outcome is looking increasingly likely .

That is the warning from Alison Dennis, life sciences partner at Fieldfisher law firm, who has closely studied the...

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More from Europe

June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 
• By Amanda Maxwell

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.

NICE’s Rules-Based Pathway And Innovator Passports Get Go-Ahead In UK NHS 10-Year Plan

 
• By Ashley Yeo

The NHS 10-Year Plan officially released on July 3 will crystalize NICE’s Rules-Based Pathway – a new concept for medtech evaluation that will come with a guarantee of funding – but only for a select number of products. Government to also introduce “innovator passport” to speed innovation into NHS.

Medtronic’s ‘Strategic Expansion’ Into Remote Monitoring

 
• By Natasha Barrow

“The Corsano wearable strengthens Medtronic’s acute care and monitoring portfolio,” Marc De Martini, vice president at Medtronic, told Medtech Insight.

European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

More from Geography

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By Elizabeth Orr

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.

Medtronic’s ‘Strategic Expansion’ Into Remote Monitoring

 
• By Natasha Barrow

“The Corsano wearable strengthens Medtronic’s acute care and monitoring portfolio,” Marc De Martini, vice president at Medtronic, told Medtech Insight.

European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.