Brexit day is almost upon us and whilst the final outcome is still unknown, one thing is (almost) certain, the UK is leaving the EU. This leaves many medical device manufacturers with somewhat of a dilemma.

If you’re in the UK and want to export to the EU (or any other territory which recognises the CE mark), you will need to obtain certification with an EU27 Notified Body and get yourself an EU Authorised Representative. The EU Rep’s name and address will also need to appear on your labelling and IFU.

If you’re outside the UK and want to export to the UK, you will need a UK Representative. Currently, the UK Rep’s details do not need to be printed on your labelling, you just need an agreement in place to confirm the relationship.

Inevitably, this is going to result in more regulatory time and additional cost, so be prepared.

Either way, we’ve got you covered.

Annette Callaghan Limited can act as your UK Representative.

Annette Callaghan (Ireland) Limited can act as your EU Representative.

Email us at info@annettecallaghan.co.uk, or send us a message via the contact page for more information or to request a proposal.