Harmonised Standards MDR IVDR

The plan and the current harmonized standards

The purpose of this harmonised standard list for MDR and IVDR is to gain detailed understanding of the current status and the planned future list. Therefore, we have consolidated the harmonised standards list with regard to the MDR and IVDR and the commission’s harmonisation plan. However, the harmonised standards are far from being complete, as discussed here.

Mandate 575 : 2021-03-12

We’ve done our best to get this list right, but making it comes down to detail-intensive, manual work. If you find mistakes, please let us know, so we can correct them. Thank you SWITEC and SNV for your expert input.

We smuggled some un- harmonized standard in… Some standards are magic 🙂

Page Structure

To make this page more readable we dived this big list into the following sections:

  1. Harmonised Process Standards
  2. Harmonised Product Standards
    1. For electrical equipment (IVDs)
    2. For medical electrical equipment (MDs)
    3. Symbols & labeling
    4. Biocompatibility (MDs)
    5. Sterilization and Packaging
    6. Aseptic Processing
    7. MDs: Additional performance standards
    8. IVDs: Additional harmonised standards

Last update harmonised standard list MDR and IVDR: 12.05.2023

Harmonised Process Standards MDR and IVDR

The following standards are digitally available within ColabON software. Contact us for an offer!

CEN Reference Standard Number
SNV Reference 		Standard Titleplanned
M565		MDR harm. DateIVDR harm. DateComment
EN ISO 13485:2016,
EN ISO 13485:2016/A11:2021
EN ISO 13485:2016/AC:2020
SN EN ISO 13485:2016,
SN EN ISO 13485:2016/A11:2021		Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)26 May 2020OJ L 138 – 17/05/2022OJ L 135 –
12/05/2022		Already in ColabON,

Corresponce of Amendment A11 entered with IVDR/MDR!

EN ISO 13485:2016/AC:2020 *for MDD and IVDD see for explanation
EN ISO 14155:2011+AC:2011 Clinical investigation of medical devices for human subjects – Good clinical practice 26 May 2020not harmonised n/aISO 14155:2020
83 pages
EN ISO 14971:2019,
EN ISO 14971:2019/A11:2021		Medical devices – Application of risk management to medical devices (ISO 14971:2019)26 May 2020OJ L 138 – 17/05/2022OJ L 135 – 12/05/2022Already in ColabON together with ISO/IEC Guide 63 and ISO/TR 24971:2020 – Technical Report – Medical Devices Risk Management

Corresponce of Amendment A11 entered with IVDR/MDR!

Already in ColabON
n/aMedical devices — Guidance on the application of ISO 14971 (ISO/TR 24971)n/an/an/aEssential for the application of ISO 14971:2019

Already in ColabON
EN IEC 62304:2006+A1:2015 CSVMedical device software – Software life-cycle processes 27 May 2024not harmonised not harmonised Already in ColabON
EN IEC 62366-1:2015+AC:2016 CSVMedical devices – Application of usability engineering to medical devices 27 May 2024not harmonised not harmonised Already in ColabON
In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916)26 May 2022n/anot harmonised New standard
ISO 20916:2019
IEC 80001-1:2011Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software – Part 1: Application of risk management27 May 2024not harmonised n/aIEC 80001-1:2021
IEC publication date: 2021-09-21
IEC 81001-5-1:2021Health software and health IT systems safety, effectiveness and security – Part 5-1: Security – Activities in the product life cycle (IEC 81001-5-1)27 May 2024not harmonised not harmonised IEC 81001-5-1:2021

Already in ColabON
IEC 82304-1:2017Health Software – Part 1: General requirements for product safety27 May 2024not harmonised not harmonised IEC 82304-1:2016
IEC publication date: 2016-10

enlarges process requirements for healthcare software, e.g. software not being medical device or ivd

Already in ColabON
Harmonised standard list for process standards

Product Standards

For electrical equipment (IVDs)

CEN Reference Standard Number
SNV Reference 		Standard Titleplanned
M565		IVDR harm. DateComment
EN 61010-1:2010+A1:2019+AC:2019Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements27 May 2024not harmonisedIEC 61010-1:2010+AMD1:2016 CSV 

IEC 61010-1/AMD2 work in progress: forecast publication date 2024-04-30

666 pages
New in ColabON
EN 61010-2-101:2017Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment27 May 2024not harmonisedIEC 61010-2-101:2018
3rd edition

52 pages
Medical electrical equipment harmonised standard list extract

For medical electrical equipment (MDs)

IEC 60601-1 includes also process requirements for hardware and software development. Additionally, the presented V-Model fits to the process requirements of IEC 62304 Software Development.

Somehow, standards with particular requirements (IEC 60601-2-x) didn’t make it on the list. However, they are a great source for product requirements. To describe basic safety and essential performance.

CEN Reference Standard Number
SNV Reference 		Standard Titleplanned
M565		MDR harm. DateComment
EN 60601-1:2006+AC:2010+A1:2013+A12:2014 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance 27 May 2024not harmonised IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV
Is working with the current ISO 14971
IEC TR 60601-4-5:2021Medical electrical equipment – Part 4-5: Guidance and interpretation – Safety related technical security specifications for medical devices27 May 2024not harmonised IEC TR 60601-4-5:2021

Already in ColabON
EN 60601-1-2:2015 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests 27 May 2024not harmonised 
EN 60601-1-3:2008+AC:2010+A11:2016 Medical electrical equipment – Part 1-3: General requirements for basic safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-ray equipment 27 May 2024not harmonised 
EN 60601-1-6:2010+A1:2015 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability27 May 2024not harmonised 
EN 60601-1-8:2007+AC:2010+A11:2017+prA2 Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 27 May 2024not harmonised 
EN 60601-1-10:2008+A1:2015 Medical electrical equipment – Part 1-10: General requirements for basic safety and essential performance – Collateral Standard: Requirements for the development of physiologic closed-loop controller 27 May 2024not harmonised 
EN 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 27 May 2024not harmonised 
EN 60601-1-12:2015 Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment 27 May 2024not harmonised 
EN IEC 60601-2-83:2020,
EN IEC 60601-2-83:2020/A11:2021

SN EN IEC 60601-2-83:2020,
SN EN IEC 60601-2-83:2020/A11:2021 		Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipmentun-plannedOJ L 1 – 05/01/2022amendment?
Medical electrical equipment harmonised standard list extract

Symbols and labeling: Harmonised Standards MDR and IVDR

The following table summarizes the harmonised standard list on the topic of symbols and labeling.

CEN Reference Standard Number
SNV Reference 		Standard Titleplanned
M565		MDR harm. DateIVDR harm. DateComment
EN ISO 15223-1:2021

SN 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)26 May 2020OJ L 1 – 05/01/2022 OJ L 4 – 07/01/2022Already in ColabON
ISO 15223-2:2010Symbols to be used with medical device labels, labelling, and information to be suppliedn/an/an/aAlready in ColabON
EN 15986:2011 Symbol for use in the labelling of medical devices – Requirements for labelling of medical devices containing phthalates 26 May 2020not harmonised n/a
SN EN ISO 20417:2021Medical devices – Information to be provided by manufacturer (ISO 20417) 27 May 2024not harmonised n/aSuccessor of SN EN 1041,
on list of FDA consensus standards
Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Medical devices not intended for direct patient contact (ISO 17664-2)27 May 2024not harmonised not harmonised new standard
EN ISO 18113-1:2011
…
EN ISO 18113-5:2011
In vitro diagnostic medical devices – Information
supplied by the manufacturer (labelling) – Part 1:
Terms, definitions and general requirements

Parts 1-5		n/a
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Biocompatibility: Harmonised standards MDR

The following harmonised standard list focuses on biocompatibility. Where this list is only applicable to medical devices.

CEN Reference Standard Number
SNV Reference 		Standard Titleplanned
M565		MDR harm. DateIVDR harm. Date
EN ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process 27 May 2024 not harmonised n/a
EN ISO 10993-3:2014 Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity 27 May 2024not harmonised n/a
EN ISO 10993-4:2017 Biological evaluation of medical devices – Part 4: Selection of tests for interactions with blood 27 May 2024not harmonised n/a
EN ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity 27 May 2024not harmonised n/a 
EN ISO 10993-6:2016 Biological evaluation of medical devices – Part 6: Tests for local effects after implantation27 May 2024not harmonised n/a 
EN ISO 10993-7:2008+AC:2009 Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals 27 May 2024not harmonised n/a 
EN ISO 10993-9:2021
SN 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)27 May 2024OJ L 1 – 05/01/2022n/a 
EN ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization 27 May 2024not harmonised n/a 
EN ISO 10993-11:2018 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity 27 May 2024not harmonised n/a
EN ISO 10993-12:2021
SN EN ISO 10993-12:2021		Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021)27 May 2024OJ L 1 – 05/01/2022 n/a
EN ISO 10993-13:2010 Biological evaluation of medical devices – Part 13: Identification and quantification of degradation products from polymeric medical devices 27 May 2024not harmonised n/a 
EN ISO 10993-14:2009 Biological evaluation of medical devices – Part 14: Identification and quantification of degradation products from ceramics 27 May 2024not harmonised n/a
EN ISO 10993-15:2009 Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys 27 May 2024not harmonised n/a 
EN ISO 10993-16:2017 Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables 27 May 2024not harmonised n/a
EN ISO 10993-17:2009 Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances 27 May 2024not harmonised n/a 
EN ISO 10993-18:2009 Biological evaluation of medical devices – Part 18: Chemical characterization of materials 27 May 2024not harmonised n/a 
EN ISO 10993-23:2021
SN EN ISO 10993-23:2021		Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021)27 May 2024OJ L 256 – 19/07/2021n/a
Medical devices biocompatibility standards

Sterilization and Packaging: Harmonised Standards IVDR and MDR

The following standards are an extraction form the harmonised standard list with respect to packaging.

CEN Reference Standard Number
SNV Reference 		Standard Titleplanned
M565		MDR harm. DateIVDR harm. DateComment
EN ISO 11135:2014,
EN ISO 11135:2014/A1:2019

SN EN ISO 11135:2014,
SN EN ISO 11135:2014/A1:2019		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)
EN ISO 11135:2014/A1:2019		27 May 2024OJ L 256 – 19/07/2021OJ L 258 – 20/07/2021
EN ISO 11137-1:2015,
EN ISO 11137-1:2015/A2:2019

SN EN ISO 11137-1:2015,
SN EN ISO 11137-1:2015/A2:2020		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)
EN ISO 11137-1:2015/A2:2019		27 May 2024OJ L 256 – 19/07/20211 OJ L 258 – 20/07/2021EN ISO 11137-1:2015/A2:2019 equivalent to SN EN ISO 11137-1:2015/A2:2020

date difference due to national adoption
EN ISO 11737-1:2018,
EN ISO 11737-1:2018/A1:2021

SN EN ISO 11737-1:2018,
SN EN ISO 11737-1:2018/A1:2021 		Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)27 May 2024OJ L 1 – 05/01/2022OJ L 4 – 07/01/2022
EN ISO 11137-2:2015 Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose 27 May 2024not harmonized n/a
EN ISO 11737-2:2020

SN 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)27 May 2024OJ L 256 – 19/07/2021OJ L 258 – 20/07/2021
EN 556-1:2001 +AC:2006Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices27 May 2024not harmonisednot harmonised 
EN 556-2:2015 Sterilization of medical devices – Requirements for medical devices to be designated ”STERILE” – Part 2: Requirements for aseptically processed medical devices27 May 2024not harmonised not harmonised 
EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems 27 May 2024not harmonised not harmonised 
EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes 27 May 2024not harmonised not harmonised 
EN ISO 14160:2021

SN EN ISO 14160:2021		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) 27 May 2024OJ L 1 – 05/01/2022n/a 
EN ISO 14937:2009 Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices 27 May 2024not harmonised not harmonised 
EN ISO 17665-1:2006 Sterilization of health care products – Moist heat – Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices 27 May 2024not harmonised not harmonised 
EN ISO 20857:2013 Sterilization of health care products – Dry heat – Requirements for the development, validation and routine control of a sterilization process for medical devices27 May 2024not harmonised not harmonised 
EN ISO 25424:2019

SN 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)27 May 2024OJ L 256 – 19/07/2021OJ L 258 – 20/07/2021 
EN 285:2015+A1:2021Sterilization – Steam sterilizers – Large sterilizers27 May 2024OJ L 138 – 17/05/2022n/a
Harmonised Sterilization and Packaging Standards

Aseptic Processing: Harmonised standandards MDR IVDR

The following standards apply to both, medical devices and in-vitro diagnostic devices that are processed aseptically.

CEN Reference Standard Number
SNV Reference 		Standard Titleplanned
M565		MDR harm. DateIVDR harm. DateComment
EN ISO 13408-1:2015 Aseptic processing of health care products – Part 1: General requirements 27 May 2024not harmonised not harmonised 
EN ISO 13408-2:2018 Aseptic processing of health care products – Part 2: Filtration 27 May 2024not harmonised not harmonised 
EN ISO 13408-3:2011 Aseptic processing of health care products – Part 3: Lyophilization 27 May 2024not harmonised not harmonised 
EN ISO 13408-4:2011 Aseptic processing of health care products – Part 4: Clean-in-place technologies 27 May 2024not harmonised not harmonised 
EN ISO 13408-5:2011 Aseptic processing of health care products – Part 5: Sterilization in place 27 May 2024not harmonised not harmonised 
EN ISO 13408-6:2021

SN EN ISO 13408-6:2021
Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021)27 May 2024OJ L 1 – 05/01/2022OJ L 4 – 07/01/2022
EN ISO 13408-7:2015 Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products 27 May 2024not harmonised not harmonised 
EN 14885:2018 Chemical disinfectants and antiseptics – Application of European standards for chemical disinfectants and antiseptics 27 May 2024not harmonised n/a
Aseptic Processing

Other medical device performance standards

The following topics for medical devices are presented in the table:

  • Non-active Implants
  • Processing Information
  • Animal tissues
CEN Reference Standard Number
SNV Reference 		Standard Titleplanned
M565		MDR harm. DateComment
EN ISO 14630:2012Non-active surgical implants – General requirements 27 May 2024not harmonised 
EN ISO 17664-1:2021
SN 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 (ISO 17664-1:2021)26 May 2020OJ L 1 – 05/01/2022
EN ISO 22442-1:2015 Medical devices utilizing animal tissues and their derivatives – Part 1: Application of risk management 27 May 2024not harmonised 
EN ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling 27 May 2024not harmonised 
EN ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy 27 May 2024not harmonised 
Harmonised standard list extraction to Animal tissues, non-active implants, and processing information.
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Harmonised standards for IVDs

In-vitro diagnostic medical device

The following table shows and extraction form the harmonised standard list only applicable to in vitro vitro diagnostic medical devices.

CEN Reference Standard Number
SNV Reference 		Standard Titleplanned
M565		IVDR harm. DateComment
EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing 27 May 2024not harmonised 
EN 13612:2002+AC:2002 Performance evaluation of in vitro diagnostic medical devices 27 May 2024not harmonised 
EN 13641:2002 Elimination or reduction of risk of infection related to in vitro diagnostic reagents 27 May 2024not harmonised 
EN 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices – Statistical aspects 27 May 2024not harmonised 
EN 14136:2004 Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures 27 May 2024not harmonised 
EN ISO 15193:2009 In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Requirements for content and presentation of reference measurement procedure 27 May 2024not harmonised 
EN ISO 15194:2009 In vitro diagnostic medical devices – Measurement of quantities in samples of biological origin – Requirements for certified reference materials and the content of supporting documentation 27 May 2024not harmonised 
EN ISO 15197:2015 In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus 27 May 2024not harmonised 
EN ISO 17511:2021 In vitro diagnostic medical devices – Requirements for
establishing metrological traceability of values
assigned to calibrators, trueness control materials and
human samples (ISO 17511:2020)		27 May 2024OJ L 4 – 07/01/2022
EN ISO 18113-1:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions and general requirements 30 September 2021not harmonised 
EN ISO 18113-2:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use 30 September 2021not harmonised 
EN ISO 18113-3:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use 30 September 2021not harmonised 
EN ISO 18113-4:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing 30 September 2021not harmonised 
EN ISO 18113-5:2011 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In vitro diagnostic instruments for self-testing 30 September 2021not harmonised 
EN ISO 23640:2015 In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents 27 May 2024 not harmonised 
In vitro diagnostic medical derives specials from harmonised standard list

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