Post Brexit: Notified bodies in the UK no longer issue CE certificates

Dr. Guido Middeler
Middeler
Dr. Guido Middeler
Partner
For medical devices made by British manufacturers that want to remain marketable in the EU, the last-minute Brexit deal has not brought any relief: As of 31 December 2020, British Notified Bodies are no longer allowed to issue CE certificates. For medical devices of class IIa, IIb and III, however, these certificates are a prerequisite for access to the European market. Conversely, certificates from notified bodies from the EU will soon no longer be recognised in the UK.

The transitional period for certificates from EU Notified Bodies aren’t long either: In the UK, these CE certificates will only be recognised until the end of June 2023. That's just under two and a half years, which will quickly fly by in the search for a Notified Body with free capacities.

For British manufacturers with ambitions on the European market, this may seem like a luxury problem: new certificates from UK Notified Bodies will no longer be recognised in the EU after Brexit on 1 January 2021.

European Authorised Representative (EAR) and UK Responsible Person

Diapharm helps suppliers of medical devices to overcome the trenches of Brexit. Companies outside the EU can place medical devices on the market in the European Union with the help of our European Authorised Representative (EAR) service. For conformity assessments, it is possible to transfer existing British certificates to a European Notified Body. It is also possible for companies from the EU to go to the UK in cooperation with our UK Responsible Person service.

At Diapharm, we have long experience of the requirements that companies based outside the EU must meet on their way to European markets. We support both UK companies that want to maintain a presence in the European market and European companies that want to continue to sell their products in the UK.

Diapharm finds solutions for medical devices in EU/UK

With our offices in Germany and the UK, we are well-positioned on both sides of the channel to offer our clients pragmatic and regulation-compliant solutions. Contact us!

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