MHRA ‘Aware Of UK Cliff Edge’ In Post-Brexit Devices Regulation Plan

The UK government’s response to the MHRA consultation on future device regulation will be published very soon. So says the agency’s new health care access officer. But will there be enough time for companies to comply with it?

Shutterstock

The sense that the UK Medicines and Healthcare products Regulatory Agency (MHRA) may have a contingency plan to ensure device manufacturers have enough time to comply with the new UKCA marking regulation grows with every week that the MHRA/government response to the UKCA marking consultation is delayed.

This promised document ̶ the next stage in the process to establish UK-specific device regulation ̶ is already many weeks...

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

UK’s Dementia Trials Accelerator Works To Fast-Track Trial Recruitment

 

A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.

UK MHRA Ready To Evolve Approach To In-House Manufactured Medtech

 
• By 

The UK device regulator wants to align health institution device exemptions with its evolving policy of agile regulation of medtech in the British market. It asks stakeholders to complete a survey by Sept. 15.

Daye Breaks Into Hormone Self-Testing, Adds New Data To Extensive Gynecology Database

 

Daye is launching an at-home reproductive hormone testing service in the UK, utilizing a painless upper arm blood collection method. The product’s UKAS lab accreditation helps build credibility with healthcare providers.

HistoSonics Sells Majority Stake To Investor Syndicate In Deal Valued At $2.25Bn

 
• By 

HistoSonics’ CEO Michael Blue describes the deal as a win-win for all stakeholders and plans to use the money to expand clinical indications, as well as the global reach, for its Edison system.

More from Europe

Cardiology And PTA Procedures In Germany’s Expanded Hybrid DRGs List 2026

 
• By 

2026 reimbursement calculations for the list of hybrid DRGs – a mechanism to incentivize day cases over inpatient surgery – will be issued in few weeks’ time. The medtech industry has made its demands known.

Daye Breaks Into Hormone Self-Testing, Adds New Data To Extensive Gynecology Database

 

Daye is launching an at-home reproductive hormone testing service in the UK, utilizing a painless upper arm blood collection method. The product’s UKAS lab accreditation helps build credibility with healthcare providers.

EU4Health Boost For Orphan Devices And SMEs

 
• By 

EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.