Medtech SMEs Set Out Regulatory Needs As UK Advances Post-EU System

UK regulatory update: February 2023, part II

While the UK continues to develop the future medtech regulatory system for Great Britain, a new market access report recommends how the MHRA should simplify regulatory processes for SMEs.

Shutterstock

The possible recognition of devices approved in trusted global markets is a major item on the medtech agenda of the UK as it develops its standalone system.

The Medicines and Healthcare products Regulatory Agency (MHRA) is an official observer of the Medical Device Single Audit Program (MDSAP)....

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

Investors Urged To Prioritize Patient Engagement To Ensure Clients’ Products Succeed

 

To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.

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.”