This page contains information about medical devices and in-vitro diagnostics in relation to a no deal Brexit scenario. In case of a no deal Brexit, all existing agreements concerning medical devices and in-vitro diagnostics in all classifications as included in applicable EU legislation lapses. To guarantee the import of the above mentioned products, an exemption on the grounds of Article 8 of the Medical Devices Act has been made.

You can submit an application for an exemption if:

  • You are a manufacturer/ autorized representative¬†of medical devices and/or in vitro diagnostics.
  • You wish to trade your medical devices on the Dutch market after the Brexit date.
  • You possess a CE certificate issued by one of the British Notified Bodies that has not been transferred on time to a Notified Body in an EU27 member state.

You also need to submit the following documents:

  • A certificate issued by a British Notified Body.
  • A proof of application confirmed by a Notified Body from one of the 27 EU countries.
  • If available, a confirmed action plan with time lines for acquiring the new CE certificate.

Only fully completed applications will be processed.

In order to be eligible for this procedure you can submit an application.

We will let you know whether your application has been granted, only whenever a Brexit has taken place.

You can find the specific conditions and enforcement rules of this procedure as well as more information (also in English available) about Brexit at Rijksoverheid.nl and brexitloket.nl

If any questions remain, please send us an e-mail: medische_hulpmiddelen@minvws.nl