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: 48 harmonised standards.
- Base Decision: CID (EU) 2021/1182 (consolidated to 2025-10-20)
- Latest Amendment: CID (EU) 2026/193
- EC Summary Page: health.ec.europa.eu
Note: EN ISO 24971 (risk management guidance) is not a harmonised standard. It is a companion guidance document to ISO 14971 and does not create a presumption of conformity.
GSPR Correspondence
The GSPR (General Safety and Performance Requirements) comprises 23 clauses across three chapters of EU MDR Annex I:
- Chapter I (GSPR 1–9): General requirements
- Chapter II (GSPR 10–22): Requirements for design and manufacture
- Chapter III (GSPR 23): Requirements for information supplied with the device
The correspondence between harmonised standards and GSPR depends on device type. The following is a general applicability analysis.
Quality Management
| Standard | Title (Summary) | GSPR Reference | Notes |
|---|---|---|---|
| EN ISO 13485:2016 + AC:2018 + A11:2021 | Medical devices — Quality management systems | Annex IX, XI (conformity assessment) | Applicable to all devices; presumption of conformity with QMS requirements |
Risk Management
| Standard | Title (Summary) | GSPR Reference | Notes |
|---|---|---|---|
| EN ISO 14971:2019 + A11:2021 | Medical devices — Application of risk management | GSPR 1, 3 (risk minimisation) | Applicable to all devices; foundational standard for risk management |
Biocompatibility
| Standard | Title (Summary) | GSPR Reference |
|---|---|---|
| EN ISO 10993-4:2017 + A1:2025 | Selection of tests for interactions with blood | GSPR 10.4 (blood compatibility) |
| EN ISO 10993-9:2021 | Framework for identification and quantification of degradation products | GSPR 10.4 (chemical safety) |
| EN ISO 10993-10:2023 | Tests for skin sensitisation | GSPR 10.4 (sensitisation) |
| EN ISO 10993-12:2021 | Sample preparation and reference materials | GSPR 10.4 (biological evaluation methods) |
| EN ISO 10993-15:2023 | Identification and quantification of degradation products from metals and alloys | GSPR 10.4 (chemical safety) |
| EN ISO 10993-17:2023 | Toxicological risk assessment | GSPR 10.4 (toxicological safety) |
| EN ISO 10993-18:2020 + A1:2023 | Chemical characterization of medical device materials | GSPR 10.4 (chemical characterisation) |
| EN ISO 10993-23:2021 | Tests for irritation | GSPR 10.4 (irritation) |
| EN 455-3:2023 | Medical gloves — Part 3: Biological evaluation | GSPR 10.4 (glove biocompatibility) |
Note: Some widely-used standards such as EN ISO 10993-1 (biological evaluation framework), EN ISO 10993-5 (cytotoxicity), EN ISO 10993-7 (EO residuals), and EN ISO 10993-11 (systemic toxicity) are currently not on the harmonised standards list and do not create a presumption of conformity, but remain industry-accepted evaluation methods.
Sterilization and Sterile Packaging
| Standard | Title (Summary) | GSPR Reference |
|---|---|---|
| EN 285:2015+A1:2021 | Large steam sterilizers | GSPR 11.1 (sterilization process validation) |
| EN 556-1:2024 | Requirements for STERILE-designated devices (terminally sterilized) | GSPR 11.1 (sterility assurance) |
| EN 556-2:2024 | Requirements for STERILE-designated devices (aseptically processed) | GSPR 11.1 (sterility assurance) |
| EN 14180:2025 | Low temperature steam and formaldehyde sterilizers | GSPR 11.1 (sterilization process validation) |
| EN ISO 11135:2014 + A1:2019 | Ethylene oxide sterilization | GSPR 11.1 (EO sterilization) |
| EN ISO 11137-1:2015 + A2:2019 | Radiation sterilization — Part 1 | GSPR 11.1 (radiation sterilization) |
| EN ISO 11137-2:2015 + A1:2023 | Radiation sterilization — Part 2 | GSPR 11.1 (sterilization dose setting) |
| EN ISO 11607-1:2020 + A1:2023 | Packaging for terminally sterilized devices — Part 1 | GSPR 11.1 (packaging material requirements) |
| EN ISO 11607-2:2020 + A1:2023 | Packaging for terminally sterilized devices — Part 2 | GSPR 11.1 (packaging process validation) |
| EN ISO 11737-1:2018 + A1:2021 | Microbiological methods — Part 1 | GSPR 11.1 (bioburden determination) |
| EN ISO 11737-2:2020 | Microbiological methods — Part 2 | GSPR 11.1 (sterility testing) |
| EN ISO 13408-1:2024 | Aseptic processing — Part 1 | GSPR 11.1 (aseptic processing general requirements) |
| EN ISO 13408-6:2021 | Aseptic processing — Part 6 (isolator systems) | GSPR 11.1 (isolator systems) |
| EN ISO 14160:2021 | Liquid chemical sterilizing agents | GSPR 11.1 (liquid chemical sterilization) |
| EN ISO 17665:2024 | Moist heat sterilization | GSPR 11.1 (moist heat sterilization) |
| EN ISO 18562-1:2024 | Biocompatibility of breathing gas pathways — Part 1 | GSPR 10.4 + 11 (respiratory devices) |
| EN ISO 18562-2:2024 | Biocompatibility of breathing gas pathways — Part 2 | GSPR 10.4 + 11 (respiratory devices) |
| EN ISO 18562-3:2024 | Biocompatibility of breathing gas pathways — Part 3 | GSPR 10.4 + 11 (respiratory devices) |
| EN ISO 18562-4:2024 | Biocompatibility of breathing gas pathways — Part 4 | GSPR 10.4 + 11 (respiratory devices) |
| EN ISO 25424:2019 + A1:2022 | Low temperature steam and formaldehyde sterilization | GSPR 11.1 (LTSF sterilization) |
| EN ISO 7197:2024 | Neurosurgical implants (hydrocephalus shunts) | GSPR 11.1 (sterile implants) |
Labelling and Symbols
| Standard | Title (Summary) | GSPR Reference |
|---|---|---|
| EN ISO 15223-1:2021 | Symbols for medical device labelling | GSPR 23.1, 23.2 (labelling information requirements) |
Clinical Investigation
| Standard | Title (Summary) | GSPR Reference |
|---|---|---|
| EN ISO 14155:2020 + A11:2024 | Clinical investigation of medical devices — GCP | Annex XV (clinical investigation procedures) |
Electrical Safety
| Standard | Title (Summary) | GSPR Reference |
|---|---|---|
| EN IEC 60601-2-83:2020 + A11:2021 | Particular requirements for home light therapy equipment | GSPR 9 (electrical safety), GSPR 14 (EMC) |
Medical Gloves
| Standard | Title (Summary) | GSPR Reference |
|---|---|---|
| EN 455-1:2020+A2:2024 | Single-use medical gloves — Part 1 (freedom of holes) | GSPR 10.4 (biocompatibility), GSPR 11 (sterility) |
| EN 455-2:2024 | Single-use medical gloves — Part 2 (physical properties) | GSPR 10.4 (physical properties) |
Patient Handling Equipment
| Standard | Title (Summary) | GSPR Reference |
|---|---|---|
| EN 1865-2:2024 | Ambulance patient handling equipment — Part 2 (power assisted stretcher) | GSPR 9 (mechanical safety), GSPR 14 |
| EN 1865-6:2024 | Ambulance patient handling equipment — Part 6 (powered chairs) | GSPR 9 (mechanical safety), GSPR 14 |
Device Processing and Reprocessing
| Standard | Title (Summary) | GSPR Reference |
|---|---|---|
| EN ISO 17664-1:2021 | Processing information — Part 1 (critical and semi-critical devices) | GSPR 23.4 (reprocessing instructions) |
| EN ISO 17664-2:2023 | Processing information — Part 2 (non-critical devices) | GSPR 23.4 (reprocessing instructions) |
Non-Active Surgical Implants
| Standard | Title (Summary) | GSPR Reference |
|---|---|---|
| EN ISO 14630:2024 | Non-active surgical implants — General requirements | GSPR 9 (mechanical performance), GSPR 10 (material safety) |
| EN ISO 21535:2024 | Hip-joint replacement implants — Specific requirements | GSPR 9, GSPR 10 |
| EN ISO 21536:2024 | Knee-joint replacement implants — Specific requirements | GSPR 9, GSPR 10 |
Surgical Textiles and Masks
| Standard | Title (Summary) | GSPR Reference |
|---|---|---|
| EN 13795-1:2025 | Surgical clothing and drapes — Part 1 (surgical gowns and drapes) | GSPR 11 (barrier performance), GSPR 10 |
| EN 13795-2:2025 | Surgical clothing and drapes — Part 2 (clean air suits) | GSPR 11 (barrier performance) |
| EN 14683:2025 | Medical face masks — Requirements and test methods | GSPR 11 (bacterial filtration efficiency) |
Small-Bore Connectors
| Standard | Title (Summary) | GSPR Reference |
|---|---|---|
| EN ISO 80369-2:2024 | Small-bore connectors — Part 2 (enteral applications) | GSPR 14.5 (misconnection prevention) |
Data Layer Source Files
Standards data is stored by category in eu_mdr/standards/, comprising 13 JSON files + _index.json.
GSPR Applicability Note
The GSPR correspondence above is a general analysis. Actual applicability depends on the specific device type, intended purpose and risk classification. Manufacturers should conduct a device-specific GSPR applicability assessment and document it in the technical file.