MHRA issues “responsible person” guidance – Med-Tech Innovation

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The Medicines and Healthcare products Regulatory Agency (MHRA) has advised medtech firms to designate a ‘responsible person’ ahead of Brexit, updating guidance it provided in February.

This is to ensure that medical devices remain on the market in the event of a no deal Brexit, with the UK currently due to leave the European Union on 31st October.

Manufacturers from outside of the UK who wish to register a device with the MHRA must be undertaken by said designated responsible person, with a registered UK address who will take responsibility for the device in the UK.

It outlines that in certain cases that the UK responsible person may not be a company, but an address where official documentation can be sent will need to be provided. The guidance also states that no labelling changes will be required to reflect the role of the UK responsible person.

You can read the full medical device guidance from the MHRA here.




MHRA issues “responsible person” guidance – Med-Tech Innovation