Chapter 2 in the Tale of Brexit, Medical Devices and MDR / IVDR: Suggestions for coping with the regulatory uncertainty
The UK is facing a perfect regulatory storm with the timing for Brexit and the staggered application of the various provisions of MDR and IVDR, with most of the provisions of the latter not being brought onto the UK statute book by the current draft of the EU (Withdrawal) Bill. Without clear guidance from the UK government on this point, it is difficult for medical device companies to know what to do to ensure that they might be able to continue to sell their devices on the market in the UK and the EU27 after Brexit. This post provides some ideas for how to cope with the uncertainty, ensuring you might prepare for the most favourable position in readiness for Brexit (scroll to section 4. at the bottom if you want the advice without the theory).
In this blog article we look at the recent commitment from the Health Secretary, Jeremy Hunt, and Business Secretary, Greg Clark, to continue close co-operation with the EU and European Medicines Agency after Brexit.
It's all a question of timing: Medical Devices, In Vitro Diagnostic Devices, EU Regulations, and Brexit
Understand how the timetable for Brexit and the timetable for MDR and IVDR overlap and the consequences for the UK that these two regulations will never be part of UK law...
The UK Life Sciences industry is waiting to see the Government's plans for product and other regulation: -will we go for a "soft" Brexit, largely following and harmonising with EU laws, or a "hard" Brexit, looking at a completely sovereign system: a British solution?