The European Commission has issued a Notice drawing attention to the legal ramifications of Brexit for industrial products placed on the EU-27 market in the event of no alternative arrangements being agreed for a transition period.

Conformity Assessments

EU legislation requires certain product conformity assessments to be carried out by Notified Bodies. After Brexit, unless agreed otherwise in transitional arrangements, UK Notified Bodies will not be able to perform EU conformity assessments. Businesses are advised to ensure that, if they intend to place such products on the EU-27 market after the withdrawal date, they are in possession of conformity assessment certificates issued by an EU-27 Notified Body. Alternatively, they should consider arranging for a transfer – on the basis of a contractual arrangement between the manufacturer, the UK Notified Body and the EU-27 Notified Body - of the file and the corresponding certificate to an EU-27 Notified Body.

Economic Operators

In the absence of agreement on transitional arrangements, after Brexit a manufacturer or importer established in the UK will no longer be considered to be an economic operator established in the EU. As a consequence, a company in the EU-27 that is currently considered to be an EU distributor of UK products will become an “importer” and will have to comply with the specific obligations relevant to importers, which differ from those of distributors.

In addition, if manufacturers are currently required (for certain products e.g. medical devices) or choose to designate an “authorised representative” or a “responsible person”, such persons must be established in the EU. After Brexit, such persons that are established in the UK will no longer be recognised as such for the purposes of the applicable EU product legislation. Manufacturers are advised to ensure that, in the event of no agreement on transitional arrangements, their designated “authorised representatives” and “responsible persons” are established in the EU-27 from the withdrawal date.

While the EU and the UK have made clear their intention to negotiate transitional arrangements that would largely maintain the status quo for about two years after Brexit, the outcome of those negotiations remains uncertain. It is therefore prudent for businesses to prepare for the possibility of ‘no deal’.