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Please note this is an extract of the original bulletin.

Medical devices: UK approved bodies

Page summary:
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

Change made:
Added: LNE-GMED UK Limited in-vitro medical devices scope. LNE-GMED UK Limited active implantable medical devices scope

Notify MHRA about a clinical investigation for a medical device

Page summary:
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

Change made:
Updated guidance for manufacturers PDF attachment

Medical devices given exceptional use authorisations during the COVID-19 pandemic

Page summary:
List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.

Change made:
Updated List of medical devices given exceptional use authorisations and List of medical devices that are no longer covered by an exceptional use authorisation.

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