Are you a quality manager for a small medical device start-up looking to expand into global markets? Or maybe you are a seasoned device manufacturer preparing to once again traverse quality regulations to deliver a new product to the European market?
The Brexit predictions that came true, those that didn’t—and what we didn’t see coming - BMJ
03/08/2022
Six years after the referendum we can disentangle the evidence and judge the effects on health and care, says Richard Vize.
For new medical devices entering the UK market, they will only need to comply with the old, and for some, less stringent, device standard (MDR, 2002). / ... Coupled with the additional authorisation process required to reach the UK market, this may lead to delays or deter companies from selling their products in the UK altogether.
Medical devices illustrate the limited scope for post-Brexit UK divergence from EU rules, and the trade-offs the UK must face. / 'Many manufacturers have suggested they will not bother with the additional cost and complexity of putting their devices through the UKCA processes on top of the updated European process.'