Standards

StandardStandard URL
ISO 13485 - Medical DevicesISO 13485:2016
ISO 14971 - Risk ManagementISO 14971:2019
Harmonised to IVDR (EU) 2017/746Harmonised to IVD Directive 98/79/EEC
Harmonised to MDR (EU) 2017/745Harmonised to MD DIrective 93/42/EEC
UK Designated Standards (IVD)UKCA Designated Standards List for IVDs
UK Designated Standards (MD)UKCA Designated Standards List for Medical Devices
UK Designated Standards (AIMD)UKCA Designated Standards List for Active Implantable Medical Devices

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