UK MedTech Regulatory Status: ABHI’s Regulatory Conference and Membership Survey raise red flags

Evnia news

Last week, for the first time in 3 years, the ABHI Regulatory Conference was held in person!

Speakers from Medtech industry, notified bodies, legal stakeholders, and ex-Medicines and Healthcare products Regulatory Agency executives joined to discuss the UK regulatory status quo and the whereabouts of the UKCA conformity assessment.

As expected, there have been lots of questions and discussions on potential pragmatic solutions as the industry is fastly approaching the UKCA marking deadline. Although the expectation is that MHRA will be announcing a generous transition period, stakeholders can’t help but bring up the damage to growth opportunities for the UK HealthTech sector due to the ongoing regulatory uncertainty.

The post-Brexit regulatory field is struggling to leverage the best of MDR, MDSAP, and FDA systems in an effort to integrate abridged conformity assessments to catch up on the lost time. But similar to the EU, the limited capacity of designated bodies and delays in the publication of the final regulation are not only posing significant challenges for patients seeking access to life-enabling technologies but also jeopardizing the security of the supply chain and withholds development of #innovation.

The recent ABHI membership survey clearly reflects the above. For this reason, Evnia has summarized the key findings and key recommendations!

Read more here

Read the summary ABHI Survey