Medical Devices, Brexit and the UKCA

As you are aware, the UK will leave the European Union, often referred to as Brexit, on the 31 December 2020.

The outcome of Brexit negotiations has not yet been determined which means there are currently no agreed post-Brexit transitional arrangements.

Please be reminded that unless the outcome of Brexit negotiations makes specific provision for EU Representatives, it will become a legal requirement from the 01 January 2021 that manufacturers who are based in Great Britain (GB) and hold CE certification from an EU Notified Body such as BSI NL (2797) to have an Authorised Representative based in EU. 

Approval of the Authorised Representative is required under the scope of your CE certification with BSI NL (2797). Changes to your approved CE certification will be required following a review of representative labels, Information for Users, the draft Declaration of Conformity, and the contract between the manufacturer and the EU Authorised Representative. 

With only limited time remaining until Brexit, you are strongly encouraged to consider making provision for an Authorised Representative for continued access to the European market if you have not already done so.

Should you wish to request approval of an Authorised Representative, please complete the change request form (MDF4900) and return it to your BSI Scheme Manager.

As you are aware, the UK will leave the European Union, often referred to as Brexit, on the 31 December 2020.

The outcome of Brexit negotiations has not yet been determined, which means there are currently no agreed post-Brexit transitional arrangements.

Manufacturers located outside of the European Union are required to appoint an authorised representative, who must be established in the European Community and is explicitly designated to act and be addressed by authorities and bodies in the European Community with regard to the manufacturer’s obligations under the directive.

Please be reminded that unless the outcome of Brexit negotiations makes specific provision, Authorised Representatives located in Great Britain (GB) will cease to fulfil the definition of Authorised Representative following the UK’s exit from the European Union on the 31 December 2020.

With only limited time remaining until Brexit, you are strongly encouraged to review your provisions for an Authorised Representative in the European Community for continued access to the European market if you have not already done so.

Approval of the Authorised Representative is required under the scope of your CE certification with BSI NL (2797). Changes to your approved CE certification will be required following a review of representative labels, Information for Users, thedraft Declaration of Conformity, and the contract between the manufacturer and the EU Authorised Representative. 

Should you wish to request approval of an Authorised Representative, please complete the MDF4900 change request form (MDF4900) and return it to your BSI Scheme Manager.