EU MDR Harmonised Standards
Harmonised standards under EU MDR 2017/745 are published by the European Commission in the Official Journal of the EU (OJ). Applying a harmonised standard creates a presumption of conformity with the corresponding GSPR requirements (EU MDR Article 8).
Data Source and Version
Data sourced from official EUR-Lex publications. Total: 51 harmonised standards across 10 categories.
- Base Decision: CID (EU) 2021/1182
- Latest Amendment: CID (EU) 2026/760
- EC Summary Page: health.ec.europa.eu
Biocompatibility
| Standard | Title | GSPR Reference |
|---|---|---|
| EN ISO 10993-4:2017 | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) | GSPR 10, 10.1, 10.4, 10.4.1 |
| EN ISO 10993-9:2021 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019) | GSPR 10, 10.1, 10.4, 10.4.2 |
| EN ISO 10993-10:2023 | Biological evaluation of medical devices - Part 10: Tests for skin sensitisation (ISO 10993-10:2021) | GSPR 10, 10.1, 10.4, 10.4.1 |
| EN ISO 10993-12:2021 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021) | GSPR 10, 10.2 |
| EN ISO 10993-15:2023 | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019) | GSPR 10, 10.1, 10.4, 10.4.2 |
| EN ISO 10993-17:2023 | Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023) | GSPR 10, 10.1, 10.2, 10.4.1, 10.4.4... |
| EN ISO 10993-18:2020 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020) | GSPR 10, 10.1, 10.2, 10.4.1, 10.4.2... |
| EN ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021) | GSPR 10, 10.1, 10.4, 10.4.1 |
Breathing Gas Pathways
| Standard | Title | GSPR Reference |
|---|---|---|
| EN ISO 18562-1:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024) | GSPR 10, 10.1, 10.4, 11 |
| EN ISO 18562-2:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024) | GSPR 10, 10.1, 10.4 |
| EN ISO 18562-3:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs) (ISO 18562-3:2024) | GSPR 10, 10.1, 10.4, 10.4.2 |
| EN ISO 18562-4:2024 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2024) | GSPR 10, 10.1, 10.4, 10.4.2 |
Clinical Investigation
| Standard | Title | GSPR Reference |
|---|---|---|
| EN ISO 14155:2020 | Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020) | GSPR 7 |
Connectors
| Standard | Title | GSPR Reference |
|---|---|---|
| EN ISO 80369-2:2024 | Small-bore connectors for liquids and gases in healthcare applications - Part 2: Connectors for respiratory applications (ISO 80369-2:2024, Corrected version 2025-06) | GSPR 10, 10.3, 14, 14.2 |
Electrical Safety
| Standard | Title | GSPR Reference |
|---|---|---|
| EN IEC 60601-2-83:2020 | Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment | GSPR 14, 14.1, 14.2, 14.6, 14.7... |
General
| Standard | Title | GSPR Reference |
|---|---|---|
| EN IEC 60118-0:2024 | Electroacoustics - Hearing aids - Part 0: Measurement of the performance characteristics of hearing aids | GSPR 14, 14.1, 14.2 |
| EN 455-1:2020+A2:2024 | Medical gloves for single use - Part 1: Requirements and testing for freedom of holes | GSPR 10, 10.1, 10.4, 11 |
| EN 455-2:2024 | Medical gloves for single use - Part 2: Requirements and testing for physical properties | GSPR 10, 10.1, 10.3 |
| EN 455-3:2023 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation | GSPR 10, 10.1, 10.4, 10.4.1 |
| EN 1865-2:2024 | Patient handling equipment used in ambulances - Part 2: Power assisted stretcher | GSPR 1, 3, 9, 14, 14.1 |
| EN 1865-6:2024 | Patient handling equipment used in ambulances - Part 6: Powered chairs | GSPR 1, 3, 9, 14, 14.1 |
| EN ISO 17664-2:2023 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021) | GSPR 11, 11.2, 23 |
| EN 13060:2025 | Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing | GSPR 11, 11.5, 11.6 |
| EN ISO 13408-1:2024 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023) | GSPR 11, 11.5, 11.6 |
| EN ISO 13408-6:2021 | Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021) | GSPR 11, 11.5, 11.6 |
| EN ISO 14160:2021 | Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives (ISO 14160:2020) | GSPR 11, 11.5, 11.6, 13 |
| EN 14180:2025 | Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing | GSPR 11, 11.5, 11.6 |
| EN 14222:2021+A1:2025 | Stainless steel steam boilers | GSPR 11, 11.5 |
| EN ISO 17665:2024 | Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024) | GSPR 11, 11.5, 11.6 |
| EN ISO 25424:2019 | Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018) | GSPR 11, 11.5 |
| EN 285:2015+A1:2021 | Sterilization - Steam sterilizers - Large sterilizers | GSPR 11, 11.5, 11.6 |
| EN 556-1:2024 | Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices | GSPR 11, 11.3, 23 |
| EN 556-2:2024 | Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices | GSPR 11, 11.3, 23 |
| EN ISO 7197:2024 | Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2024) | GSPR 10, 10.1, 10.3, 11, 19 |
| EN ISO 14630:2024 | Non-active surgical implants - General requirements (ISO 14630:2024) | GSPR 19 |
| EN ISO 21535:2024 | Non-active surgical implants - Joint replacement implants - Specific requirements for hip-joint replacement implants (ISO 21535:2023) | GSPR 10, 10.1, 10.3, 11, 19 |
| EN ISO 21536:2024 | Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2023) | GSPR 10, 10.1, 10.3, 11, 19 |
| EN 13795-1:2025 | Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns | GSPR 10, 10.1, 10.4, 11, 11.1 |
| EN 13795-2:2025 | Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits | GSPR 10, 10.1, 10.4, 11, 11.1 |
| EN 14683:2025 | Medical face masks - Requirements and test methods | GSPR 10, 10.1, 10.4, 11 |
Labelling
| Standard | Title | GSPR Reference |
|---|---|---|
| EN ISO 15223-1:2021 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021) | GSPR 4, 10, 10.4.5, 11, 11.8... |
| EN ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices | GSPR 11, 11.2, 23 |
Quality Management
| Standard | Title | GSPR Reference |
|---|---|---|
| EN ISO 13485:2016 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) | GSPR 1, 3, 4, 5, 6... |
Risk Management
| Standard | Title | GSPR Reference |
|---|---|---|
| EN ISO 14971:2019 | Medical devices - Application of risk management to medical devices (ISO 14971:2019) | GSPR 1, 2, 3, 4, 5... |
Sterilization
| Standard | Title | GSPR Reference |
|---|---|---|
| EN ISO 11135:2014 | Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) | GSPR 11, 11.5, 11.6, 14, 14.1 |
| EN ISO 11137-1:2015 | Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) | GSPR 11, 11.5, 11.6 |
| EN ISO 11137-2:2015 | Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) | GSPR 11 |
| EN ISO 11607-1:2020 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) | GSPR 8, 11, 11.4, 11.7, 23... |
| EN ISO 11607-2:2020 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) | GSPR 8, 11, 11.4 |
| EN ISO 11737-1:2018 | Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) | GSPR 11, 11.3 |
| EN ISO 11737-2:2020 | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019) | GSPR 11, 11.3 |
GSPR Applicability Note
The GSPR correspondence above is a general analysis. Actual applicability depends on the specific device type, intended purpose and risk classification.