On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the EU.
The notice presents the steps that manufacturers of medical devices and IVDs should take to avoid negative after-effects following Brexit.
UK Manufacturers and Importers and EU-based Distributors
The Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR) provide that manufacturers, importers, distributors and authorized representatives fall within the definition of an “economic operator”.
After Brexit, the UK would become a third country. The notice provides that any UK manufacturer or importer or authorized representative (AR) will no longer be perceived as an economic operator established within the EU after Brexit. Moreover, EU distributors of UK medical devices or IVDs based in the remaining Member States will become importers of third-country products thereafter. Consequently, they will have to comply with specific obligations, which are different from those of a distributor.
Authorized Representatives
According to the MDD/MDR and the IVDD/IVDR, manufacturers of medical devices imported into the EU from a third country are required to appoint an authorized representative established in the EU (“European Authorised Representative” – EU AR).
It is currently estimated that approximately 50% of the European Authorized Representatives in the medical devices industry are based in the UK. After 29 March 2019 (the date set for Brexit), authorized representatives established in the UK will not be considered as European Authorised Representatives and will, therefore, be unable to fulfill this role on behalf of non-EU legal manufacturers.
The MDR and the IVDR also introduce a new requirement for manufacturers and EU AR’s to have at their disposal at least one qualified person responsible for regulatory compliance (‘PRRC’/QP) who should be based in the EU. [Article 15].
Non-recognition of UK-Notified Bodies
According to the document, following the anticipated withdrawal of the UK from the EU, UK Notified Bodies will not be considered EU Notified Bodies. They will be erased from the European Commission’s Nando database, which includes the details of all Notified Bodies in the EU. As a result, UK Notified Bodies will no longer be permitted to provide conformity assessment services in accordance with EU product legislative framework and issue related CE Certificates of Conformity.
Medical devices which are CE marked by UK legal manufacturers and are placed on the EU market will, after Brexit, need to have related CE Certificates of Conformity issued by a Notified Body licensed by the competent authorities of one of the 27 EU Member States.
Legal manufacturers of medical devices that currently hold a CE Certificate of Conformity issued by a UK notified body yet intending to continue marketing their devices in the EU will be required to choose one of two solutions.
- They will need to seek a CE Certificate of Conformity issued by a notified body licensed in one of the remaining EU Member States.
or
- They will need to transfer the technical file and related to the medical device and the existing CE Certificate of Conformity issued by a UK notified body to a notified body licensed in one of the remaining EU Member States on the basis of a contractual arrangement between the manufacturer, the UK Notified Body and the Notified Body of one of the remaining Member States.
Please contact our office for more information.