January 22nd DG Grow, the European Commission’s Directorate General for Internal Market, Industry, Entrepreneurship and SMEs, issued a notice to stakeholders on the withdrawal of the UK. The document speaks clear language on how the UK will be separating itself from the rest of the EU and states how stakeholders, including medtech stakeholders must respond. This new statement is what will apply unless the UK can reverse it by reaching a transitional arrangement. The aim of the statement is to remind all interested parties, and especially economic operators, of the legal repercussions, which need to be considered when the United Kingdom becomes a third country.
The importer is the economic operator established in the Union who places a product from a third country on the Union market. As from the withdrawal date, both manufacturers and importers established in the United Kingdom will no longer be considered as being established in the European Union. Consequently, the economic operator downstream of the UK based manufacturer or importer, having a registered place of business within the EU territory, will become the EU importer as from the withdrawal date. This operator will have to comply with the specific obligations relevant to an importer.
As the UK will be considered a third country an authorised representative established in the Union will need to be designated by the UK manufacturers.
In addition, the authorised representatives established in the UK will not, as from the withdrawal date, be recognised as authorised representatives any longer. Therefore, manufacturers are advised to take the necessary steps to ensure that, as from the withdrawal date, their designated authorised representatives are established in the EU.
As from the withdrawal date, UK Notified Bodies will lose their status as EU Notified Bodies and will be removed from the Commission’s information system on notified organisations (NANDO database).
Conformity Assessment Certificates
Only certificates delivered by a body recognised as an EU Notified Body at the time of the placing of that product on the market is required for products placed on the EU market. That implies that, as of the withdrawal date, economic operators holding certificates issued by a UK Notified Body are no longer recognised. Manufacturers need to consider either applying for a new certificate issued by an EU Notified Body or arranging for a transfer of the file and the corresponding certificate from the UK Notified Body to an EU Notified Body if they wish to continue placing products on the EU market after the withdrawal date.
What does this mean to you?
Unless any transitional arrangements can be made in a withdrawal agreement the reality of Brexit will hit us in a little over 14 months’ time.
- Are you a UK based manufacturer or importer? Have you identified who could function as EU importer as of the withdrawal date and is this economic operator ready to comply with their new obligations?
- Have you considered who could function as authorised representative?
- Is your current authorised representative based in the UK? Do you have an alternative based in an EU country?
- How many of your certificates are issued by UK Notified Bodies? Have you discussed with them a contingency plan?
- Are you going to wait to take action in the hopes of a transitional agreement taking form or are you going to avoid all risks and make an action plan now?
Don’t hesitate to contact us for more information.