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Focus on Regulation

Brexit – what’s next for medical devices?

On 22 January 2018, the European Commission released a notice to stakeholders concerning the United Kingdom’s (“UK”) possible withdrawal from the European Union (“EU”) and the EU rules in the field of industrial products, including medical devices and in vitro medical diagnostic medical devices. The notice presents the steps that manufacturers of medical devices and IVDs should take to avoid negative after-effects following Brexit. Should the position expressed in the notice prove accurate, medical device and IVD stakeholders will face stringent consequences following the UK’s withdrawal from the EU.

UK Manufacturers and Importers and EU-based Distributors

EU product legislation[1] as well as the new Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation provide that importers, manufacturers, distributors of products and authorised 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 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.

Authorised Representatives

According to the Medical Devices Directive and In Vitro Diagnostic Medical Devices Directive, as well as the new Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation, manufacturers of medical devices imported into the EU from a third country are required to appoint an authorised representative established in the EU (“European Authorised Representative”).

It is currently estimated that approximately 50% of the European Authorised Representatives in the medical devices industry are based in the UK. After 29 March 2019 (the date set for Brexit), authorised representatives established in the UK will not be considered as European Authorised Representatives and will, therefore, be unable to fulfil this role on behalf of non-EU legal manufacturers.

The Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation also introduce a new requirement for manufacturers and European Authorised Representatives to have at their disposal at least one qualified person responsible for regulatory compliance who should be based in the EU. The limited recommendation for manufacturers provided by the European Commission in this respect in the notice is to “take the necessary steps to ensure that, as from the withdrawal date, their designated authorised representatives or responsible persons are established in the EU-27“.

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. According to the first solution, they will need to seek a CE Certificate of Conformity issued by a notified body licensed in one of the remaining EU Member States. The second option would be 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.

 

[1] See for example: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices; Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices; Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys; Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC; Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC; Directive 2014/90/EU of the European Parliament and of the Council of 23 July 2014 on marine equipment and repealing Council Directive 96/98/EC.