Impact of Brexit on medical devices and in vitro diagnostic devices

December 24, 2020, 4 pm: The information on this page will possibly be updated in accordance with the partnership between the EU and the UK.

The UK’s withdrawal from the EU on 31 January 2020 will have an impact on the trade in medical devices and in vitro diagnostics. Below, read how care providers and businesses can prepare for these effects.

What are medical devices?

A medical device is any instrument, apparatus, appliance, software, material or other article that falls under the Medical Devices Act and is used in healthcare. Medicines are not medical devices.

What are in vitro diagnostic devices?

In vitro diagnostic devices are used to test samples of human tissue, like blood or urine. Examples include blood glucose meters, pregnancy tests and tests for genetic disorders.

Trade in medical devices and in vitro diagnostics after Brexit

During the transition period medical devices and in vitro diagnostics with a CE mark from a UK notified body recognised by the EU can be traded freely with the EU. After this, the EU rules for importing such products from third countries will apply.

If a transaction is concluded before the end of the transition period, medical devices that were produced and brought onto the market before the end of that period may remain on the market. The manufacturer must prove when the transaction was concluded.

Registration of medical devices and in vitro diagnostic devices after Brexit

Before the transition period ends, manufacturers must transfer the conformity (CE) registration of medical devices and in vitro diagnostic devices from their UK notified body to a recognised notified body in one of the remaining 27 EU member states. After this period, products with a British CE mark may no longer be brought onto the market.

Under the withdrawal agreement the UK must, at the request of the manufacturer, ensure that all information held by UK notified bodies about specific CE certificates is transferred to a notified body in an EU27 country before the end of the transition period. The manufacturer is responsible for submitting such a transfer request in good time.

Labelling of medical devices after Brexit

During the transition period medical devices and in vitro diagnostic devices can be traded freely between the UK and the EU. As of 1 January 2021 the rules for importing such products from third countries will apply to the UK. One rule concerns conformity with European regulations. To demonstrate conformity manufacturers will have to obtain a CE certificate from a recognised notified body in one of the 27 remaining EU member states. After 1 January 2021 the product label must state the identification number of the new notified body.