MHRA Offers Medtechs Extra Transition Time For UK Regulatory System Compliance

UK regulator to allow three- and five-year transitions for CE-marked devices and diagnostics

26 June saw the release finally of the UK government’s official response to the MHRA’s 2021 consultation on its post-Brexit medical devices regulatory framework. The considered response, held up by political and internal timing issues, represents an implementation plan for reform of the system. Crucially it allows industry extra compliance time.

Closeup of mobile phone screen with logo lettering of UK MHRA agency, serum vials and syringe background.
• Source: Alamy

Section 15 – Transitional Arrangements – was the part of the UK government’s plan for future medtech regulation that most readers rushed to when this long-awaited response to the Medicines and Healthcare products Regulatory Agency’s (MHRA) consultation was published on 26 June.

The MHRA will have a lot on its mind this week, including the release of its it “One Agency” brand...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United Kingdom

Thena Capital’s New Fund Up And Running With £1M Investment In Plexāā’s Breast Cancer Device

 

Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.

Milner Pitch Day: Multiomic Pathology, Microcancer Avatars And Cell Morphology Intelligence

 

The Milner Institute, the on-campus hub for start-up acceleration at Cambridge University, hosted its annual Pitch Day on July 1. Start-ups Panakeia, PathwayBio and Sentinal4D presented diagnostic technologies.

Questions Over UK Prevention Agenda Within NHS 10-Year Plan

 
• By 

The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.

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

 
• By 

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.

More from Europe

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By 

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 

MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”

Questions Over UK Prevention Agenda Within NHS 10-Year Plan

 
• By 

The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.