Medical device manufacturers operating in the European region will face two major regulatory challenges in 2020, the new European medical device regulation MDR (EU) 2017/745 and the Brexit. With the withdrawal of the United Kingdom from the European Union on 1 February 2020, the Brexit deal, which was negotiated during October 2019, has finally come in force. This means that the transition period ending on 31 December 2020 will apply. Until this date, medical device manufacturers need to get prepared for the new situation, which for several circumstances can be quite time consuming, in particular for UK-based manufactures which plan to continue selling their products in the EU.
Manufacturers located within the UK
Manufacturers located in the UK, which do not have their own establishment in an EU-27 country, will have to designate a sole Authorised Representative in an EU-27 member state. In particular, manufacturers of class I medical devices should keep in mind that the EU Authorised Representative will need to verify and keep available a copy of the technical documentation in accordance with Article 11 of the new European MDR.
SCC can assist in preparing or updating the technical documentation for all risk class devices in line with the MDR (EU) 2017/745 to keep selling allowance within the EU.
Manufacturers working with Notified Bodies located within the UK
UK-based Notified Bodies will no longer be recognised by the EU. Thus, manufacturers are required to transfer their files to a Notified Body located within the EU-27 or obtain new certificates from an EU-27 Notified Body. The two big UK Notified Bodies BSI Assurance and SGS UK offer an internal transfer to their establishments in the Netherlands (BSI) respectively Belgium or Finland (SGS).
Manufacturers working with Authorised Representatives located within the UK
Similar to the Notified Bodies, UK-based Authorised Representatives will no longer be recognised by the EU. In order to place devices on the EU market, manufacturers with an Authorised Representative based in the UK will need to establish a new Authorised Representative in the EU-27.
Manufacturers exporting their medical devices to the UK
In case no other solution will be negotiated, manufacturers exporting their product to the UK will need to nominate a UK Responsible Person. The UK Responsible Person will have to be established in the UK and acts on behalf of a manufacturer established outside the UK, to carry out specified tasks in relation to the manufacturer’s obligations. This will include registering with the Medicines and Healthcare products Regulatory Agency (MHRA) before the device is placed on the UK market. The MHRA will continue to allow devices to be placed on the UK market that have been CE marked under and fully conform with the applicable EU legislation.