The Spanish Agency of Medicines and Medical Devices (AEMPS) has published a Checklist to verify the Brexit readiness of companies based in Spain in the sector of:
- Devices with a Notified Body (NB) established in the UK: manufacturer must ask for a new Certificate from a EU27 NB or for the transferal of their Certificate to one of the EU 27 NBs before 31st January 2020. All documentation, labels and IFUs must be updated to reflect the change of NB.
- Devices manufactured in the UK or devices for which the EAR is based in the UK: manufacturers must ensure they have an EAR in one of EU 27 Member State. All documentation, labels and IFUs must be updated to reflect the change of EAR.
- Spanish companies designated as EAR for Class I devices or custom-made devices manufacturer from a non-European country or the UK: must communicate the information to the AEMPS.
- Companies that want to import devices from the UK: ask for an importers license to AEMPS.
- To actualize all communications of putting into service on the corresponding portal (CCPS).
- Responsible Person established in Spain of a UK manufacturer: to actualize the information on the CPNP (Cosmetic Product Notification Portal) and apply the necessary changes to the labelling.
- Spanish distributors which will now become importers of products from the UK: to send AEMPS a declaration responsible of the importing activity.
- UK manufacturers: to verify that the packaging/labelling includes an RP from EU 27 and the Country of Origin.
Finally, the AEMPS recommends stablishing the necessary measures to make sure that there are enough devices in stock to guarantee the continuity of sales as of 31st January 2020.
As a professional Responsible Person Center and European Authorized Representative, Obelis specializes in the European Regulatory framework and will continue monitoring the latest developments to provide our clients with the most accurate and up-to-date information.
Junior Consultant RA/QA
November 25th, 2019
Furthermore, Obelis has, officially established Obelis UK Ltd., the purpose of which is to serve as a UK Responsible Person for our clients, who will need a representative in the United Kingdom. If you wish to know more about our future projects, please do not hesitate to contact us.