2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

According to Article 8 (Use of harmonised standards) of the Regulation on Medical Devices:

  1. Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof. The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’). References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union.
  2. References in this Regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, in particular on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, provided that references to those monographs have been published in the Official Journal of the European Union.

This web page provides you with updated information on the European standard supporting the implementation of EU Directives and regulations. It provides, on one hand the information corresponding to the real-time status of the standards provided by CEN and CENELEC and, on the other hand, provides updated information about the status of the standards in support of the European legislation. It may happen that a standard is withdrawn by the standardisation body and remains applicable in the context of the EU legislation, unless the reference is withdrawn from the official journal.

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77 - Draft standards 41 - View all published standards related to this directive 0 - Withdrawn standards

Harmonised Standards or standards supporting the application of the EU legislation

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)

60.60 Standard published

L 256 Official journal reference
Jul 19, 2021 Official journal publication date

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)

60.60 Standard published

L 256 Official journal reference
Jul 19, 2021 Official journal publication date

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)

60.60 Standard published

L 1 Official journal reference
Jan 5, 2022 Official journal publication date

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

60.60 Standard published

L 1 Official journal reference
Jan 5, 2022 Official journal publication date

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

60.60 Standard published

L 1 Official journal reference
Jan 5, 2022 Official journal publication date

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020)

60.60 Standard published

L 1 Official journal reference
Jan 5, 2022 Official journal publication date

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 (ISO 17664-1:2021)

60.60 Standard published

L 1 Official journal reference
Jan 5, 2022 Official journal publication date

Biological evaluation of medical devices - Part 23: Tests for irritation (ISO 10993-23:2021)

60.60 Standard published

L 256 Official journal reference
Jul 19, 2021 Official journal publication date

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)

60.60 Standard published

L 256 Official journal reference
Jul 19, 2021 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

L 138 Official journal reference
May 17, 2022 Official journal publication date

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)

60.60 Standard published

L 256 Official journal reference
Jul 19, 2021 Official journal publication date

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)

60.60 Standard published

L 256 Official journal reference
Jul 19, 2021 Official journal publication date

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)

60.60 Standard published

L 256 Official journal reference
Jul 19, 2021 Official journal publication date

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

60.60 Standard published

L 1 Official journal reference
Jan 5, 2022 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

L 1 Official journal reference
Jan 5, 2022 Official journal publication date

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)

60.60 Standard published

L 1 Official journal reference
Jan 5, 2022 Official journal publication date

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

60.60 Standard published

L 1 Official journal reference
Jan 5, 2022 Official journal publication date

Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

60.60 Standard published

L 1 Official journal reference
Jan 5, 2022 Official journal publication date

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)

60.60 Standard published

L 1 Official journal reference
Jan 5, 2022 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

L 1 Official journal reference
Jan 5, 2022 Official journal publication date

Sterilization - Steam sterilizers - Large sterilizers

60.60 Standard published

L 138 Official journal reference
May 17, 2022 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

L 1 Official journal reference
Jan 5, 2022 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

L 1 Official journal reference
Jan 5, 2022 Official journal publication date

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

60.60 Standard published

L 138 Official journal reference
May 17, 2022 Official journal publication date

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

60.60 Standard published

L 138 Official journal reference
May 17, 2022 Official journal publication date