Medical devices and Brexit
The UK had decided to leave the EU including the single market and the customs union. Consequently, the trading conditions between the UK and Denmark will change.
The exact deal between the EU and the UK is still being negotiated, and a number of areas remain unclear. However, it is possible that the UK and the EU will not come to an agreement or that the withdrawal agreement will not be adopted by the British parliament.
If the UK leaves the EU without any collaboration or trade agreements with the EU, the UK will basically be considered a third country.
Unlike medicinal products, for example, medical devices are not approved by the authorities. As a general rule, a medical device may be placed and used on the EU/EEA only when it:
1) fulfils essential labelling, safety and performance requirements
2) has been subjected to an assessment of conformity
3) has been affixed with CE-marking (special rules apply to devices which are custom-made or intended for clinical investigations)
To manufacturers of medical devices
Notified bodies from the UK cannot perform assessments of conformity after Brexit
Manufacturers of medical devices in medium- and high-risk classes must perform an assessment of conformity with the involvement of a notified body in the EU/EEA. The notified body issues a certificate to the manufacturer if the manufacturer and the device fulfil the requirements of the medical devices legislation. Hereafter, the manufacturer can affix the CE marking to its device, and it can be marketed across the EU/EEA. The manufacturer must use a notified body that fulfils all the requirements for notified bodies appearing from the medical devices legislation to maintain certification. The two British notified bodies still certifying medical devices can no longer perform assessments of conformity if the UK leaves the EU without a deal.
Therefore, manufacturers using a UK notified must prepare for the following:
- UK-issued certificates that are used to demonstrate compliance with the legislation are no longer valid in the EU after Brexit.
- A new certificate issued by a notified body in the EU/EEA is required so the device can still be marketed and used in the EU/EEA if a no-deal Brexit is the outcome.
To Importers and distributors
The present EU27 distributors will become EU27 distributors of the medical devices they place on the EU27 market if the devices are purchased from a UK manufacturer.
The same applies to medical devices imported from third countries and placed on the UK market first.
In case of a no-deal Brexit, authorised representatives in the UK will no longer be acknowledged in the EU27.
We therefore advise you to make the necessary preparations to ensure:
- designated authorised representatives have been established in the EU after Brexit
- Re-labelling of devices to indicate a new authorised representative
The European Commission has published a number of guidelines and interpretation documents in connection with Brexit: Brexit – guidance to stakeholders on impact in the field of industrial products