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EU Medical Devices Regulation

(EU) 2017/745 — 65 entries. Source: 02021D1182-20260617. Snapshot: 2026-08-16.

AnnexReferenceTitleWithdrawal
ANNEXEN ISO 10993-23:2021Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)
ANNEXEN ISO 11135:2014Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process f
ANNEXEN ISO 11137-1:2015Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process fo
ANNEXEN ISO 11737-2:2020Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance o
ANNEXEN ISO 25424:2019Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a ste
ANNEXEN ISO 10993-9:2021Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019
ANNEXEN ISO 10993-12:2021Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
ANNEXEN ISO 11737-1:2018Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:201
ANNEXEN ISO 13408-6:2021Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
ANNEXEN ISO 13485:2016Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
ANNEXEN ISO 14160:2021Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivativ
ANNEXEN ISO 15223-1:2021Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
ANNEXEN ISO 17664-1:2021Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Cri
ANNEXEN IEC 60601-2-83:2020Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
ANNEXEN 285:2015+A1:2021Sterilization – Steam sterilizers – Large sterilizers
ANNEXEN ISO 14971:2019Medical devices – Application of risk management to medical devices (ISO 14971:2019)
ANNEXEN ISO 10993-10:2023Biological evaluation of medical devices – Part 10: Tests for skin sensitisation (ISO 10993-10:2021)
ANNEXEN 455-3:2023Medical gloves for single use – Part 3: Requirements and testing for biological evaluation
ANNEXEN ISO 10993-15:2023Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:201
ANNEXEN ISO 10993-17:2023Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
ANNEXEN ISO 10993-18:2020Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-
ANNEXEN ISO 11137-2:2015Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
ANNEXEN ISO 11607-1:2020Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2
ANNEXEN ISO 11607-2:2020Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
ANNEXEN ISO 17664-2:2023Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non
ANNEXEN ISO 13408-1:2024Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)
ANNEXEN 455-1:2020+A2:2024Medical gloves for single use – Part 1: Requirements and testing for freedom of holes
ANNEXEN 455-2:2024Medical gloves for single use – Part 2: Requirements and testing for physical properties
ANNEXEN 556-1:2024Sterilization of medical devices – Requirements for medical devices to be designated "STERILE" – Part 1: Requirements for terminally sterilized medica
ANNEXEN 556-2:2024Sterilization of medical devices – Requirements for medical devices to be designated "STERILE" – Part 2: Requirements for aseptically processed medica
ANNEXEN 1865-2:2024Patient handling equipment used in ambulances – Part 2: Power assisted stretcher
ANNEXEN 1865-6:2024Patient handling equipment used in ambulances – Part 6: Powered chairs
ANNEXEN 13795-1:2025Surgical clothing and drapes – Requirements and test methods – Part 1: Surgical drapes and gowns
ANNEXEN 13795-2:2025Surgical clothing and drapes – Requirements and test methods – Part 2: Clean air suits
ANNEXEN 14683:2025Medical face masks – Requirements and test methods
ANNEXEN 14180:2025Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing
ANNEXEN ISO 7197:2024Neurosurgical implants – Sterile, single-use hydrocephalus shunts (ISO 7197:2024)
ANNEXEN ISO 10993-4:2017Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
ANNEXEN ISO 14155:2020Clinical investigation of medical devices for human subjects – Good clinical practice (ISO 14155:2020)
ANNEXEN ISO 14630:2024Non-active surgical implants – General requirements (ISO 14630:2024)
ANNEXEN ISO 17665:2024Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for m
ANNEXEN ISO 18562-1:2024Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process (IS
ANNEXEN ISO 18562-2:2024Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024
ANNEXEN ISO 18562-3:2024Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic substances (ISO 185
ANNEXEN ISO 18562-4:2024Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate (ISO 18562-4:2024)
ANNEXEN ISO 21535:2024Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants (ISO 21535:2023)
ANNEXEN ISO 21536:2024Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants (ISO 21536:2023)
ANNEXEN ISO 80369-2:2024Small-bore connectors for liquids and gases in healthcare applications – Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected
ANNEXEN 13060:2025Sterilizers for medical purposes – Small steam sterilizers – Requirements and testing
ANNEXEN 14222:2021+A1:2025Stainless steel steam boilers
ANNEXEN IEC 60118-0:2024Electroacoustics – Hearing aids – Part 0: Measurement of the performance characteristics of hearing aids
ANNEXEN ISO 1135-4:2025Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed (ISO 1135-4:2025)
ANNEXEN ISO 1135-5:2025Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus (ISO 1135-5:2025)
ANNEXEN ISO 10993-1:2025Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk managemen
ANNEXEN ISO 10993-5:2009Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
ANNEXEN ISO 12870:2025Ophthalmic optics - Spectacle frames - Requirements and test methods (ISO 12870:2024)
ANNEXEN ISO 14607:2025Non-active surgical implants - Mammary implants - Specific requirements (ISO 14607:2024)
ANNEXEN ISO 14889:2025Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2025)
ANNEXEN ISO 15883-1:2025Washer-disinfectors - Part 1: General requirements, terms and definitions and tests (ISO 15883-1:2024)
ANNEXEN ISO 15883-2:2025Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical dev
ANNEXEN ISO 15883-3:2025Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO 15883-3:20
ANNEXEN ISO 15883-7:2025Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical dev
ANNEXEN ISO 22675:2025Prosthetics - Testing of ankle-foot devices and foot units - Requirements and test methods (ISO 22675:2024)
ANNEXEN ISO 23908:2025Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitori
ANNEXEN 60601-1:2006Medical electrical equipment - Part 1: General requirements for basic safety and essential performance