Earlier today UK Medicines and Healthcare products Regulatory Agency released an updated guidance on "Register medical devices to place on the market" that provides detailed instructions on how to register the medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the Great Britain and Northern Ireland markets.
Before medical devices can be placed on the market in Great Britain (England, Wales and Scotland), they must be registered with the MHRA.
In order to sell medical devices in Great Britain, they must be registered with the Medical Devices Registration Agency. This includes IVDs, custom-made devices, and systems and procedure packs.
You must register if you or your company sells, leases, lends or gifts:
Class I, IIa, IIb or III devices you have manufactured
Class I, IIa, IIb or III devices you have refurbished or re-labelled with your own name
any system or procedure pack containing at least one medical device
custom-made devices
IVDs you have manufactured
IVDs undergoing performance evaluation
The company/applicant needs to create an account on the Device Online Registration System (DORS) MHRADORS before one can start registering their devices.
Registration of your devices with the MHRA (the UK Competent Authority) does not represent any form of accreditation, certification, approval or endorsement by the MHRA.
Click this LINK to know more about the Information required when registering your devices with the MHRA.
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