Brexit & EU product legislation: What to expect?

Undoubtedly, the departure of the UK from the European Union (EU) will cause a major shift in the industry sector and the related EU product legislation.

On 19th January 2018, the European Commission published an official Notice to Stakeholders [Withdrawal of the United Kingdom and EU rules on company law] presenting the new rules on company law in reference to the withdrawal of the UK from the European Union.

After the withdrawal date – 30 March 2019 – as referred in the Notice and if no congruent agreement will be drawn between the parties – the UK will be considered as a ‘’a third country’’ bringing significant changes for:

Economic operators

  • Manufacturers or importers established in the UK will no longer be considered as economic operators established in the EU;
  • UK manufacturers of medical devices or cosmetics will need to designate an authorised representative or responsible person based in the EU;
  • An authorised representative / responsible person established in the UK will no longer be qualified as an EU authorised representative / responsible person;
  • EU Distributors will become “importers’’ and will need to comply with legal obligations specific to importers.

Notified Bodies and Conformity Assessment Procedures

  • UK Notified Bodies will no longer be eligible to perform conformity assessment procedures and will be removed from the NANDO website!
  • Certificates issued by the UK Notified Body – before the withdrawal date – can remain valid if a contractual arrangement is concluded between the manufacturer, the UK Notified Body, and an EU Notified Body (‘’transfer of responsibility to an EU Notified Body’’).

Manufacturers placing medical devices, IVDs, cosmetics and other products[1] on the EU market, having either a registered address in the UK or an Authorized Representative in the UK will need to take preventive actions in reference to these changes – such as designating a NEW Authorized Representative which has a registered address in the European Union. Contact us today to receive hands-on support on creating your BREXIT strategy.

[1] Annex to the Notice to Stakeholders presents an indicative list of all the affected EU product you’re an industry expert.

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