Impact of Brexit on the healthcare and medical sector
A hard Brexit will affect the medical sector in the European Union. A ‘hard Brexit’ means the United Kingdom leaving the EU without agreeing the conditions of its withdrawal. If that happens, medicines and medical equipment produced in the UK may not be available.
Brexit will also lead to changes affecting:
- the automatic recognition of British professional qualifications in healthcare;
- British residents’ automatic access to healthcare when visiting the Netherlands;
- product and food safety arrangements.
The government is currently assessing how a hard Brexit without transitional provisions will affect the supply of medicines and medical equipment. And how it can limit those risks. It is working on these questions with the European medicines regulatory network and the European Commission.
Exemption procedure on medical devices after a no deal Brexit
For public health reasons, the government wants to guarantee the availability of these medical devices. Therefore, an exceptional and standardised exemption procedure for medical devices has been drawn up specifically for the Brexit, with specific conditions and enforcement rules. This procedure only applies to the Netherlands and only for medical devices and in-vitro diagnostics, for reasons of the continuity of care.
Manufacturers of medical devices can apply for an exemption for the Netherlands at the website farmatec.nl on the basis of Article 8 of the Medical Devices Act.
In case of a no deal Brexit, medical devices will lose the recognition of their CE certificate, issued by a Notified Body located in the UK. As a result, newly produced devices can no longer be placed on the market in the EU after Brexit.
Exemption medical devices: Applicant and product information
Requirements for the exemption on medical devices
Edited on 30 April 2019.
White paper on medical devices in relation to a no deal Brexit
Updated 12 april 2019 - This document contains information about medical devices and in-vitro diagnostics in relation to a no ...