After Brexit accreditation of medical devices are UK based notified bodies is no longer valid within the European Union. A seller of a medical device the EU will require an EU 27 based certificate of conformity to support product declarations for CE marking purposes. The notified body demonstrate compliance for products place on the market after the withdrawal date.

The EU commission ‘NANDO’ website provides a listing of all European wide Notified Bodies. If a business is currently ‘CE’ marked under existing EU rules, it will be required to continue to do so post Brexit.

In the absence of establishment in an EU states such as Ireland the manufacturer of medical devices which are imported into the EU may be required under the directive to have an authorised representative in the EU. The role of Authorised Representatives The duties of an “Authorised Representative” are set out in the directives and in the new regulations. It is the manufacturer of the specific medical device that is required to establish an “Authorised Representative” within a Member State, if they themselves are not located in a Member State.

It is unclear whether UK manufacturers or manufacturers whose current “Authorised Representative” currently resides in the UK, will be required to register in another member state. The labelling requirements of an “Authorised Representative” may have significant adverse effects for supply chains. It is also a requirement that medical device label changes are notified to the respective Notified Body.