Home page > News > Last News > 10 October 2018 - About Brexit and NB, EAR and distributors located in (...)

10 October 2018 - About Brexit and NB, EAR and distributors located in UK

From : EUROPEAN COMMISSION RELEASE - Brussels, 22 January 2018 - REV.1

NOTICE TO STAKEHOLDERS WITHDRAWAL OF THE UNITED KINGDOM AND EU RULES IN THE FIELD OF MEDICAL DEVICES

Dear Partners,

Attached is a revised document released by the European Commission that may help understanding some of the most important conséquences of Brexit if it happened that no agreement could be found between UK and EU.

The attached document is divided in two parts :
- Consequences for the identification of Economic Operators ;
- Consequences for conformity assessment procédures and Notified Bodies.

To sum things up today, at the best of our knowledge :
- Notified Bodies and European authorized representatives located in UK will not be recognized anymore ;
- Distributors in UK will become " Importers"
- And so, apparently, there is still today no Mutual Recognition Agreements with UK (such as it exists today with Switzerland).

We remain at your disposal for any other/further information and advice you may need from us ; and shall be glad to help the best we can.

Best regards,

MediMark Europe HQ Teams

| Site Map | Legal mentions

© 2018 - [MediMark® Europe]. All rights reserved