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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 devices. Writing on Intertek’s website, IMNB head Sharmila Gardner said...

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23andMe Purchase Will Let Regeneron Scale Drug Development

 
• By Alaric DeArment

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.

Disparities — Including Financial Shortcomings — Remain In Women’s Health, Execs Say

 
• By Brian Bossetta

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.

Thousands Of Cardiac Digital Twins Reveal Novel Connections With Mental Health

 
• By Natasha Barrow

King’s College London, Imperial College London and The Alan Turing Institute constructed cardiac digital twins at scale, creating over 3,400, in a new study using UK Biobank data published in Nature Cardiovascular Research on 16 May.