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Regulatory Affairs information on product registrations with MHRA

By November 5, 2021No Comments

As you all know, all general IVDs have to be registered with MHRA by 31st December. We have recently had a number of issues about delays to registration raised by members, frustrated by lack of response from MHRA to email queries. Doris-Ann raised this as an agenda item for the MHRA Liaison meeting yesterday.

MHRA’s response was that they are very short of resource so there is a backlog. New staff have been recruited and are being trained. But they urge patience. However the Registrations team do feel that there is a high number of incorrect registrations from across the whole medical device industries which is adding to this issue so have asked us to please ensure members have read all the guidance and watched the videos available on how to properly follow the regulatory process for products. Here’s the link to access the video tutorials and other registration information: Register medical devices to place on the market – GOV.UK (www.gov.uk)

They also remind us that this is not an approval and if you have provided all the information to register your products, including for performance evaluation, then you can go ahead without waiting to hear from MHRA directly that your registration is successful.

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