On 10 January 2018, the European Commission issued a Notice to Stakeholders highlighting the legal and practical implications of a “No Deal” scenario for industrial products placed on the EU-27 market, to include medical devices, active implantable medical devices and in vitro medical devices.
The Notice comes at a time when leading figures in the life sciences and healthcare industries have expressed the urgent need for clarity on transition arrangements, given that there is just under 12 months until the UK’s departure from the EU, scheduled for 30 March 2019.
With the prospect of a “No Deal” Brexit still a distinct possibility, the Notice acts as a formal warning to the UK that economic operators (including manufacturers, importers, distributors, and authorised representatives) are likely to face repercussions in the absence of a mutual recognition agreement with Europe.
UK manufacturers, importers and distributors
The Notice advises that post-Brexit, UK based manufacturers or importers will no longer be considered economic operators established in the EU. As EU product legislation defines importers as entities which place products from independent third countries on the EU market, established EU distributors will, by virtue of the UK’s departure from the EU, become importers in respect of products they are placing on the market from UK based manufacturers or importers of UK products.
As highlighted by the Notice, an importer’s obligations differ from those of a distributor. For example, importers are responsible for checking that products fulfil all EU safety, health and environmental protection requirements to include verifying that the manufacturer outside the EU has taken the necessary steps to allow the product to be placed on the EU market and obtaining the necessary EU Declarations of Conformity. EU based distributors will need to ensure they are prepared to deal with any new obligations they may be placed under as potential importers.
Manufacturers of medical devices located outside the EU might be required to appoint an authorised representative to represent them in the EU and to ensure their compliance with the relevant European product legislation to include compliance with European conformity assessment procedures in relation to products released on the EU-27 market.
Unless transitional arrangements are in place by March 2019, authorised representatives established in the UK will not be recognised as authorised representatives or responsible persons for the purposes of the applicable EU product legislation. Accordingly, the Notice advises that in preparation for Brexit, all UK manufacturers must take steps to ensure that they have an authorised representative established in the EU before 30 March 2019, to enable the continued marketing of their products within Europe.
Notified Bodies and assessments
Current EU product legislation requires manufacturers of medical devices and in vitro diagnostic medical devices to appoint qualified third parties, known as Notified Bodies, to conduct conformity assessment procedures to certify that the product complies with EU standards and requirements. Compliance is evidenced by a CE certificate as well as affixing CE marking to the products themselves.
As it stands, UK Notified Bodies are recognised as EU Notified Bodies and have the powers to perform conformity assessment procedures and issue related CE certificates in accordance with EU product legislation. As of the withdrawal date, UK Notified bodies will no longer be recognised as EU Notified Bodies and will be removed from the European Commission’s information system on notified organisations (NANDO database). As such, UK Notified Bodies will no longer be able to perform conformity assessments pursuant to EU product legislation.
Consequently, CE certificates issued by UK Notified Bodies prior to the withdrawal date may be rendered void post-Brexit.
Manufacturers of medical devices and in vitro medical devices who wish to continue marketing their devices in Europe will need to either consider applying for a new CE certificate issued by an EU-27 Notified Body, or arranging a transfer of the technical file and corresponding CE certificate from the UK Notified Body to an EU-27 Notified Body, the latter taking responsibility for that certificate. The transfer would be a contractual arrangement between the manufacturer and the UK and EU-27 Notified Bodies. Either solution is likely to be costly for manufacturers which will undoubtedly impact upon product prices.
If they have not done so already, it is imperative that manufacturers of medical devices start making the necessary arrangements to avoid the early expiry of existing CE certificates issued by UK Notified Bodies. Failure to do so will result in those medical devices losing their CE marking, affecting their ability to be sold on the European market.
Manufacturers and Notified Bodies are advised to take heed of this early warning by the EU Commission to ensure they are prepared for every possible Brexit scenario.