Medilink North of England’s CEO Kevin Kiely explores the three biggest implications facing our members and the healthcare and Life Sciences industry - the new Medical Device and IVD Regulations, Brexit and the lack of capacity in Notified Bodies at a national level.
The transition period is now well under way, with medical device companies having to comply with the new regulations no later than 26 May 2020 (less than a year away!) and 2022 for IVD companies. What has largely gone under the radar is that the time it takes to get a CE Mark audit has increased dramatically due to capacity issues and the reduced number of notified bodies.
As you will be aware, the UK has agreed with the EU an extension to Article 50 until 31 October 2019 and the new government leadership is committed to come out of the EU by this date. In the event of a No Deal exit, for a limited period only, companies will continue to be allowed to place products on the UK market that are in conformity with the applicable EU Directive and that carry a CE mark – certificates issued before exit day will continue to be recognised and there won’t be any changes of labelling required.
A new UK regulatory system will be introduced, given that the UK’s participation in the European regulatory network will end, which will almost certainly mirror all the key elements of the EU regulations. In the event of a ‘Deal Brexit’, with an agreed withdrawal agreement, there would be a time limited implementation period providing a bridge to a future relationship between the UK and the EU, and companies would trade on the same terms as now until the end of 2020. And of course, there is a third scenario that may be becoming increasingly remote, that we do not leave the EU at all.
What is clear, is that whatever the position going forward, you will need to undertake risk analysis on an ongoing basis to identify risks, impact and mitigation. If you have not already undertaken a gap analysis to understand the difference between the current MDD and new MDR e.g., the additional clinical evidence required, costs, time lines, etc., then this is something that you should prioritise. Similarly, there is a real need to make initial preparations for a Deal / No Deal Brexit.