Healthcare, Medical Devices, Regulatory Affairs

MHRA explains role of UK responsible person

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have published new details on the role and responsibilities of the UK Representative if a no-deal Brexit withdrawal from the European Union comes to pass.

The updated guidancedocument explained the rules of how non-UK manufacturers could place their devices on the UK market. The manufacturers would have to engage with a ‘UK REP’ or ‘UK.Responsible Person’. The role of the UK REP was described as quite similar to that of the Authorized Representative

It is only allowed for UK based manufacturers or UK-based UK REPs to place medical devices on the UK market, and they need to register themselves.The manufacturer and UK REP will also be held liable for defective devices and they can be proceeded against under the Regulations or under the Consumer Protection Act 1987.

The UK REP is also responsible for carrying out post-market surveillance activities.

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