Regulation of devices in Northern Ireland
Page summary:
Information about the EU Regulations and their implementation in Northern Ireland
Change made:
Update to ‘Clinical investigations and performance studies in Northern Ireland’ section.
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 BSI Assurance UK Ltd medical devices scope and added DEKRA Certification UK Ltd in-vitro diagnostic medical devices scope.
Time updated:
4:33pm, 8 January 2025
