Publication of further guidance on the role of the “UK Responsible Person” in case of no-deal Brexit

On 18 September 2019, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance regarding the role and responsibilities of the “UK Responsible Person”. This is part of MHRA’s continued effort to regulate medical devices in the event of a no-deal Brexit. With the possible withdrawal of the UK from the European Union at the end of October 2019, the UK Responsible Person would be the UK equivalent of the EU Authorised Representative the role of which will then disappear as regards the UK.

The Medical Devices Regulations 2019 (UK MDR 2019) amended the existing Medical Devices Regulations 2002 (UK MDR 2002) to create this new role. The UK MDR 2019 defines the “UK Responsible Person” as “a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations“. This includes registering with the MHRA before a medical device is placed on the UK market.

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