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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:
Updated ‘DEKRA Certification UK Ltd medical devices scope’.

*Note: IVD devices are not in scope

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

Page summary:
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.

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

 

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