What does Brexit mean for medical device regulation?
With just over a month to go until Brexit day and the ongoing implementation of the new EU Medical Device Regulations (MDR), it’s certainly an interesting period for medical device companies. As the 29th March looms ever closer, it is increasingly important that these companies are prepared so that their products can continue to go to market.
What will happen when Britain leaves the EU?
- The MDR and the IVDR will still be implemented into the UK, parallel to their implementation in the EU
- The UK will become a ‘third country’ and will be considered an importer, rather than a distributor, and will need to follow non-EU import regulations
- The Medicines and Healthcare products Regulatory Agency (MHRA) will become responsible for the UK market
- After a period, UK-based Notified Bodies will no longer be in compliance with European regulations
How should medical device companies prepare?
The key for medical device companies in this complex period is preparation. Companies in the UK who are wanting to continue selling their devices into the EU market will need to:
- Appoint a European Authorised Representative (EAR) in an EU member state. It is advised to do this as soon as possible before 29th March to avoid anticipated ‘congestion’ nearer the time
- Move their UK-based Notified Bodies into an EU member state or ensure that Notified Bodies are duplicated into one
There’s more information on how companies can prepare in our UK Medical Device Regulation Report 2019 – you can download it here.
How does Brexit impact talent?
Brexit and the new EU MDR has caused the demand for regulatory affairs talent to increase by 42%.
It’s hugely important to have the right talent in place during this uncertain period, as experienced regulatory affairs specialists will enable companies to have as smooth a transition as possible and to ensure products still go to market.
Download our UK Medical Device Regulation Report 2019 here for more information on what the MDR and Brexit mean for medical device companies in the UK.