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’.