A public consultation on the UKCA marking for medtech products is anticipated later in the year. Medtech industry representatives are part of the UK regulator’s advisory team.
UK health care stakeholders are on a mission to integrate best practice and good governance into the system of medtech regulation that is replacing long-standing EU regulatory oversight in the post-Brexit era.
The first stage was the passage in February of the Medicines and Medical Devices (MMD) Act 2021. Developing the all-important secondary legislation and shaping the United Kingdom Conformity Assessment (UKCA) certification system for devices and diagnostics are the next stages
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.
Flo Health was the first femtech unicorn to be valued at over $1bn. But the company faced 49 investment rejections before reaching that status, Anna Klepchukova, the company’s chief medical officer, told the LSX World Congress Europe. THENA Capital’s Esther Reynal de St Michel Richardot talked through the firm’s gender-smart investment strategy.
With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.
One year after the UK mooted the Rules-Based Pathway to give medtechs clarity on what can be expected from an evaluation, the devices industry says UK healthtech assessment and adoption processes are still failing to meet the needs of innovators and patients.
