HEALTHCARE AND MEDICAL DEVICES E-SSENTIALS

How Brexit will impact manufacturers and importers of medical devices and In Vitro Diagnostics

february 2018, industry: healthcare and medical devices

With the United Kingdom poised to withdraw from the EU, conversations are underway about what future trade and regulatory relations between the EU and the UK will look like. While many anticipate that at a mutually beneficial withdrawal deal will emerge, private and public parties alike must prepare for the eventuality that no such deal is struck.

This article will help you understand the impact of Brexit on economic operators—including manufacturers, distributors, and importers of medical devices—in the event that no withdrawal deal is achieved.

It’s worth noting that the current timeline is uncertain. While the proposed date for withdrawal is 30 March 2019, it has been suggested that the transition period could extend through the end of 2020. Regardless, businesses affected should begin preparing immediately.

Distributors & Importers

Currently, countries located outside of the EU are considered “third countries.” Economic operators who place products from a third country on the European market are considered importers and must comply with specific Union legislation requirements that differ from those applying to products sourced from within the EU-27.

As of its formal withdrawal from the EU, the UK will be considered a third country and all of the same regulations will apply. At that time, operators who were previously considered distributors will now be considered importers and will have to adhere to all importer obligations.

Note that this may have wide-reaching consequences on distributors losing their EU-based status because the Product Liability Directive 85/374/EEC places product liability with the importer.

Action points:

• Investigate the potential impacts of the Product Liability Directive 85/374/EEC.
• Gain an understanding of the key differences between regulations affecting distributors and importers and how they relate to your products.

Manufacturers & Authorised Representatives

Medical device manufacturers based in the UK will need to designate an authorised representative established in the Union—a requirement for all operators located outside of the EU.

As of 30 March 2019, this will include UK-based operators who wish to continue placing specific devices on the European market, including medical devices and IVDs. Manufacturers are advised to pre-establish their representatives in the EU-27 before the withdrawal date.

Whether or not the UK will establish special requirements for non-UK based manufacturers and distributors exporting goods to the UK remains to be seen.

Action points:

• Manufacturers based in the UK must establish an authorised representative within the EU-27.
• Manufacturers outside of the EU with an authorised representative in the UK must designate a representative within the EU-27.

EC Certification

As of the withdrawal date, UK Notified Bodies will no longer be considered EU Notified Bodies. In other words, they’ll be removed from the European Commission’s NANDO database and will no longer be eligible for conformity assessment tasks pertaining to Union product legislation.

Additionally, all EC certificates issued by UK-based notified bodies could be void as of 30 March 2019. This will potentially affect manufacturers worldwide who currently rely on UK-based Notified Bodies.

Economic operators based outside of the EU (including the UK) must ensure that they have valid certificates issued by an EU-27 Notified Body before the withdrawal date or else risk being unable to continue offering their products on the European market.

Operators holding certificates issued by a UK Notified Body should apply for a new certificate or arrange for a transfer in order to ensure that they continue meeting all EU-sanctioned conformity procedures.

Action point:

• Manufacturers holding EC certificates issued by UK-based notified bodies must obtain new certificates issued within the EU-27, or arrange a transfer of existing certificates, before the UK’s withdrawal.

Possible consequences

While the true impact of the UK’s withdrawal from the EU remains to be seen, the most likely outcomes are additional costs—both for UK-based manufacturers who want to place their devices on the European market and EU-based manufacturers who want to export devices to the UK. However, with sufficient and timely preparation in the areas listed above, these effects can be minimised.

References: http://ec.europa.eu/newsroom/just/item-detail.cfm?item_id=612136