MHRA guidance on Regulating medical devices in the UK has been updated!
The MHRA has updated their guidance on "Regulating medical devices in the UK" with changes to some key topics: ‘Summary of key requirements for placing a device on the Great Britain market’, ‘Registrations in Great Britain’, ‘UKCA marking’, ‘CE marking and Notified Bodies’, ‘Labelling requirements’ and ‘Regulation of medical devices in Northern Ireland’ Reference Guides.
We want to draw your attention to "Register medical devices to place on the market", which provides a very detailed guidance on "Registration of certain medical devices that have expired/expiring CE certificates" and "Registration of certain medical devices which are EU MDD Class I reusable surgical instruments or EU MDD Class I medical devices upclassified from Class I".
You can access the guidance document for these specific situations here.
If you find yourself in any of these scenarios, please do not hesitate to reach out to us, and we will provide you with the necessary assistance to navigate this process.
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