On June 23, 2016, the United Kingdom (UK) voted for the UK to leave the EU, which is commonly referred to as Brexit. Since then, there has been no clear direction with regards to the outcome and the situation appears to be highly volatile.
In the case of a No-Deal scenario meaning that there will be a non-regulated leave of the UK, the UK will become a third country – this has several implications that should be considered:
- CE certificates issued by UK Notified Bodies will lose validity immediately with Brexit date
- Authorized Representatives based in the UK will no longer be able to act as an Authorized Representative under the EU legislation – only Authorized Representatives located in one of the remaining EU countries will be recognized
- Distributors located in one of the remaining EU countries who distribute products from the UK will become importers with all legal consequences
- CE marked devices will continue to be recognized for a limited period of time in the UK
- Manufacturers must register their medical devices and in vitro diagnostic medical devices with the MHRA after Brexit day – if the manufacturer is not located in the UK, a UK Responsible Person must be assigned