New UK guidance: ”no deal” scenario

The UK Government issued a new guidance in the beginning of the year on how a ”no deal” Brexit will affect the regulatory framework of medical devices.

The notice states that

”The UK will recognise medical devices approved for the EU market and CE-market.

The UK will comply with all key elements of the MDR and IVDR, which will apply in the EU from May 2020 and 2022 respectively.

UK-based Notified Bodies would no longer be able to assess the conformity of medical devices for devices to receive the CE mark and enter the EU market.

Formal UK presence at EU committees in respect of devices will cease.”

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