13 Jan AEMPS publishes information on Brexit and medical devices

The Brexit transition period ended on 31 December 2020. This concluded the UK’s representation in EU institutions, agencies, bodies, organs and bodies. The new trade and cooperation agreement with the UK is effective from 1 January 2021. We summarise the most important points for distributors and manufacturers of medical devices.

How does Brexit affect medical devices?

The AEMPS offers on its website a series of guides and documents on the new procedures. Two main issues stand out:

How to distribute your products manufactured in the UK?

Medical devices that are manufactured in the UK and placed on the European market are considered to be imported into the EU from a third country. They will therefore be subject to the relevant import of goods and foreign trade control legislation that applies to all companies purchasing goods in the UK.

How to obtain a CE marking in the EU if you are based in the UK?

From 1 January, UK Notified Bodies (NBs) will no longer be able to assess conformity under Union law. In this context, if you are in the UK and want to sell in Europe, you must certify your product with an NB located in the EU. Spain has in the AEMPS the only Spanish body that could do so.

If you already have a certificate issued by a UK NRO, you must apply for a new certificate issued by an EU NRO. You can also transfer the UK ON file and certificate to an EU ON. This change will require a change of CE marking.

If you have an authorised representative in the UK it will no longer be recognised as a European authorised representative, so the necessary changes will have to be made for it to be established in the EU.

The AEMPS is currently working in several expert groups of the European Commission and the Competent Authorities for Medical Devices (CAMD). These groups focus on finding solutions and agreements to avoid possible shortages of certain medical devices on the European market.

For its part, the European Medicines Agency (EMA) has published several guidelines with relevant information for companies. Among these, we highlight the guide explaining the protocol to be followed in Ireland and Northern Ireland. Finally, the Medicines and Healthcare Products Regulatory Agency (MHRA) has launched a checklist to find out how Brexit affects your company and what rules apply, as well as guidance on importing and exporting products.

EpisKey Medical Consulting can help you to obtain the CE marking of your medical device both inside and outside the European Union.