by Oliver Duke
Have you been swept up by the furore around the changes to the Medical Devices Directive (MDD) in the event of a no-deal Brexit?
Since the UK Brexit referendum, it has been confirmed by the European Commission that safety certificates subsequently issued by UK Notified Bodies will lose their validity immediately upon the UK’s withdrawal from the EU, unless transitional arrangements are put in place. Effectively this has meant a mass migration to Belgium/Netherlands based operations of notified bodies like the BSI or SGS to ensure continuity of approval. This exercise has added cost to British medtech businesses and it is likely that these costs will continue into 2020 given the ongoing uncertainty, not to mention the issues around setting up additional supply chain resources in these countries.
An important question to ask is; "Is this just posturing or could there be a real situation where new applications are rejected on this basis?" Time will tell.
Interestingly, we have seen an increase in the number of recruitment briefings in the regulatory specialism in the last 18 months, probably in recognition of the changing regulatory landscape and the uncertainty around the impact a no-deal Brexit will have has led medtech clients to invest extra resource in this area. There is now a real shortage of regulatory affairs specialist talent, with average salaries increasing steadily in recognition of their importance to the business.
If you need to recruit at a mid-senior level in the regulatory function and have struggled to source appropriate candidates through your own network, consider utilising a headhunting service. RMG is celebrating 25 years of headhunting in the medtech sector, we are ideally placed to help you navigate the market and acquire the best possible talent for your regulatory function.