1. Medtech Insight
  2. >>Geography
  3. >>Europe
  4. >>United Kingdom

UK Regulatory Update: MHRA Adds More Medtech UK Approved Body Capacity in August

Diagnostics industry offers food for thought on UK’s future international recognition routes

 
• By Ashley Yeo

The number of UK approved bodies designated to issue UKCA marking leapt from four to seven in August, adding much-needed file auditing capacity to Great Britain’s evolving medtech regulatory system. Next up: the MHRA’s consultation on accepting overseas-approved products onto the market.

Yu Ping Chen

Intertek became the latest medtech auditing organization to be designated as a UK approved body (UKAB), gaining permission to do conformity assessments and issue UKCA marking certificates under the UK MDR 2002 (SI 2002 No. 618, as amended) for the Great Britain market. The designation was made on 22 August, with Intertek Medical Notified Body UK Ltd (IMNB) now the seventh UKAB.

The designation by the Medicines and Healthcare products Regulatory Agency (MHRA) covers a range of active non-implantable and non-active medical...

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
Start Free Trial

Already a subscriber?

More from United Kingdom

More from Europe

Medtechs Wait For Dividend As UK Spending Review Prioritizes Healthcare And NHS

 
• By Ashley Yeo

Increased support for NHS services and delivery infrastructure announced in the 11 June government spending review by chancellor of the exchequer Rachel Reeves could boost inward investment and offer new market opportunities for medtechs.

UK Healthtech Center Of Excellence Given Key MHRA Digital Regulation Role

 
• By Ashley Yeo

Ahead of the 11 June UK spending review and its anticipated funding uplift for healthcare and life sciences, the MHRA announced an expansion of its digital expertise by creating a dedicated hub in Leeds, a renowned center of medtech excellence.

Aneira Health Launches New Precision Medicine Platform Exclusively For Women

 
• By Natasha Barrow

Cecilia Lindgren, Aneira Health’s co-founder and chief science officer, said that the company has “redesigned the diagnostic model.” The subscription-based platform offers clinical-grade and AI diagnostics alongside clinical consultation.