Projects

Use the form below to find particular standards or projects. Enter your criteria for searching (single or in combination) in the fields below and press the button “Search”. You can also search using the Advance Search facility.

Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Post-market surveillance for manufacturers (ISO/TR 20416:2020)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

60.60 Standard published

CEN/CLC/JTC 3

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

60.60 Standard published

CEN/CLC/JTC 3

Medical device traceability enabled by unique device identification (UDI)

90.20 Standard under periodical review

CEN/CLC/JTC 3

Nomenclature - Collective terms and codes for groups of medical devices

60.60 Standard published

CEN/CLC/JTC 3

Nomenclature - Collective terms and codes for groups of medical devices

90.20 Standard under periodical review

CEN/CLC/JTC 3

Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

60.60 Standard published

CEN/CLC/JTC 3

Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation

90.20 Standard under periodical review

CEN/CLC/JTC 3

Privacy of monitoring technology - Guidelines for introducing ambient and wearable monitoring technologies balancing privacy protection against the need for oversight and care

60.60 Standard published

CEN/WS 102

Information supplied by the manufacturer of medical devices

50.60 Close of voting. Proof returned by secretariat

CEN/CLC/JTC 3

Information supplied by the manufacturer of medical devices

50.60 Close of voting. Proof returned by secretariat

CEN/CLC/JTC 3

Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

60.55 Ratification completed (DOR)

CEN/TC 239

Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

60.60 Standard published

CEN/TC 239

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

90.60 Close of review

CEN/TC 239

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

60.55 Ratification completed (DOR)

CEN/TC 239

Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

90.60 Close of review

CEN/TC 239
CEN/CENELEC

Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

90.60 Close of review

CEN/CLC/JTC 3