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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). Compliance with a harmonised standard creates a presumption of conformity with the corresponding GSPR requirements.

Source

The authoritative list is maintained via Commission Implementing Decision (EU) 2021/1182 and its amendments. Always verify against the latest OJ publication.

Quality Management Systems ​

StandardTitleGSPR Reference
EN ISO 13485:2016Medical devices — Quality management systemsAnnex IX, XI

Risk Management ​

StandardTitleGSPR Reference
EN ISO 14971:2019Medical devices — Application of risk managementChapter I

Software ​

StandardTitleGSPR Reference
EN IEC 62304:2006+A1:2015Medical device software — Software life cycle processesGSPR 17
EN IEC 62366-1:2015+A1:2020Medical devices — Usability engineeringGSPR 5

Biological Safety ​

StandardTitleGSPR Reference
EN ISO 10993-1:2018Biological evaluation — Part 1: Evaluation and testingGSPR 10
EN ISO 10993-5:2009Tests for in vitro cytotoxicityGSPR 10
EN ISO 10993-7:2008+A1:2019Ethylene oxide sterilization residualsGSPR 10
EN ISO 10993-9:2021Framework for identification and quantification of degradation productsGSPR 10
EN ISO 10993-10:2021Tests for skin sensitizationGSPR 10
EN ISO 10993-11:2017Tests for systemic toxicityGSPR 10
EN ISO 10993-12:2021Sample preparation and reference materialsGSPR 10
EN ISO 10993-13:2022Identification and quantification of degradation products from polymeric medical devicesGSPR 10
EN ISO 10993-15:2019Identification and quantification of degradation products from metals and alloysGSPR 10
EN ISO 10993-16:2017Toxicokinetic study design for degradation products and leachablesGSPR 10
EN ISO 10993-17:2023Establishment of allowable limits for leachable substancesGSPR 10
EN ISO 10993-18:2020Chemical characterization of medical device materialsGSPR 10
EN ISO 10993-20:2006+A1:2015Principles and methods for immunotoxicology testingGSPR 10

Electrical Safety ​

StandardTitleGSPR Reference
EN IEC 60601-1:2006+A1:2013+A2:2021Medical electrical equipment — General requirementsGSPR 9, 14
EN IEC 60601-1-2:2015+A1:2021EMC requirementsGSPR 14
EN IEC 60601-1-6:2010+A1:2015+A2:2020UsabilityGSPR 5
EN IEC 60601-1-8:2007+A1:2013+A2:2021Alarm systemsGSPR 14
EN IEC 60601-1-9:2008+A1:2013Requirements for environmentally conscious designGSPR 14
EN IEC 60601-1-10:2008+A1:2013Requirements for the development of physiologic closed-loop controllersGSPR 14
EN IEC 60601-1-11:2015+A1:2020Requirements for medical electrical equipment used in home healthcareGSPR 14
EN IEC 60601-1-12:2014+A1:2020Requirements for medical electrical equipment intended for use in emergency medical services environmentsGSPR 14

Sterilization ​

StandardTitleGSPR Reference
EN ISO 11135:2014+A1:2019Sterilization using ethylene oxideGSPR 11
EN ISO 11137-1:2015+A2:2019Sterilization using radiation — Part 1GSPR 11
EN ISO 11137-2:2015Sterilization using radiation — Part 2GSPR 11
EN ISO 11137-3:2017Sterilization using radiation — Part 3GSPR 11
EN ISO 11607-1:2020Packaging for terminally sterilized medical devices — Part 1GSPR 11
EN ISO 11607-2:2020Packaging for terminally sterilized medical devices — Part 2GSPR 11
EN ISO 17665-1:2006+A1:2013Sterilization using moist heat — Part 1GSPR 11
EN ISO 14937:2009Sterilization using other methodsGSPR 11
EN ISO 25424:2019Sterilization using low temperature steam and formaldehydeGSPR 11

Clinical Investigation ​

StandardTitleGSPR Reference
EN ISO 14155:2020+A1:2021Clinical investigation of medical devices for human subjectsAnnex XV

Surgical Textiles & Protective Equipment ​

StandardTitleGSPR Reference
EN 13795-1:2019+A1:2023Surgical drapes, gowns and clean air suits — Part 1GSPR 11
EN 14683:2019+AC:2019Medical face masks — Requirements and test methodsGSPR 11

INFO

Source data: eu_mdr/standards/

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