UK – UK MHRA issues post-Brexit medical device, IVD registration requirements

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on registration requirements and deadlines for medical devices and IVDs effective January 1, 2021 for some products.

According to the new MHRA guidance, the January 1, 2021 registration deadlines pertain to manufacturers of Class I medical devices, IVDs and custom-made devices and that are either based in the UK or whose Authorized Representatives are based in Northern Ireland. UK regulators have scheduled grace periods for other device types based on their risk classifications…