Medtech Companies Must Prepare for Brexit Now

By Emmanuel Garnier
March 1, 2018


• Categories: 03-Manufacturing Execution, 05-Quality/Regulatory, Market Access, RC - Medtech Regulatory Resource Center

Preparing for Brexit is not just a matter for EU and national authorities, but also for private parties, notably life sciences and medtech companies throughout the world. All companies must promptly prepare for March 30, 2019, when (subject to a “transition period” that is currently subject to negotiations between the UK and the EU-27) the UK becomes a third country.

Currently, the withdrawal will have the following main consequences on all economic operators having a device placed on the EU and/or UK market.

1. Regarding the identification of economic operators

The Commission reminds that an economic operator established in the EU-27 who, prior to the withdrawal date, was considered as an EU Distributor will become an importer for the purposes of Union product legislation in relation to products from a third country that this economic operator places on the EU-27 market as from the withdrawal date. Indeed, the Importer is defined as an entity placing a device from a third country on the EU-27 market, therefore, UK-based companies can no longer be used by other third countries as importers for the EU. It also means that from withdrawal date, EU-based distributors placing a medical device on the EU-27 market from a manufacturer or importer based in the UK will themselves be considered importers.

The authorized representative (AR) designated by the manufacturer of a medical device shall also be established in the Union. AR established in the UK will not, as from the withdrawal date, be recognized as AR for the purposes of the applicable Union product legislation. Therefore, manufacturers are advised to take the necessary steps to ensure that, as from the withdrawal date, their designated AR are established in the EU-27.

Similarly, UK manufacturers will have to appoint an AR in the EU.

2. Regarding the conformity assessment and notified bodies (NB)

UK NBs will lose their status as EU NBs and will be removed from the Commission’s information system on notified organizations. As such, UK bodies will not be in a position to perform conformity assessment tasks pursuant to Union product legislation as from the withdrawal date.

Economic operators (especially manufacturers) from the rest of the world thus need to take the necessary steps to ensure that, where the applicable conformity assessment procedures require the intervention of a NB, they will hold certificates issued by an EU-27 NB to demonstrate compliance for their products placed on the market as from the withdrawal date.

Unless specifically contrary agreement is reached, where economic operators hold certificates issued by a UK NB prior to the withdrawal date and plan to continue placing the product concerned on the EU-27 market as from the withdrawal date, should consider either applying for a new certificate issued by an EU-27 NB or arranging for a transfer—on the basis of a contractual arrangement to be put in place between the manufacturer, the UK Notified Body, and the EU-27 NB—of the file and the corresponding certificate from the UK NB to an EU-27 NB, which would then take over the responsibility for that certificate.

In this respect, the EU Commission has recently issued a must-read notice to stakeholders regarding the consequences of UK withdrawal notably in the field of medical devices.