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Alison Dennis

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Alison Dennis

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3 November 2020

The medical device regulatory regime in Great Britain and Northern Ireland after 31 December 2020

The UK exited the European Union (EU) on 31 January 2020. A transition period exists until 31 December 2020, during which time medical devices continue to be regulated as if the UK is still a part of the EU.

After the transition period, the regulatory regime for medical devices in the UK will change, with a further split in regulation between Great Britain and Northern Ireland.

The EU CE mark will continue to be recognised in the whole of the UK until 30 June 2023, but there will be alternative regimes for devices placed solely on the market in the UK, which certain manufacturers might choose instead.

Whichever regime is chosen, for devices placed on the market anywhere in the UK, there will be requirements to register with the Medicines and Healthcare products Regulatory Agency both the devices and either the UK manufacturer or the person in the new role of UK Responsible Person.

Alison Dennis writes for the Journal of Medical Device Regulation on the regulatory regime for medical devices after the end of the Brexit transition period.

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