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Table of Contents
Below are lists of the European MDR / IVDR Harmonised Standards and Common Specifications.
The source links are provided in each section. Further, Casus updates this page to include newly added standards and common specifications, as needed.
Harmonized Standards
Standards are voluntary in Europe. However, devices that are in conformity with the applicable European harmonized standard(s) “shall be presumed to be in conformity with the requirements of this Regulation.”
Source Links
The full list of all European Harmonized Standards is available: HERE
The link for each list of medical device and IVD Harmonized Standards is available below:
Medical Devices under MDR 2017/745
Arranged in numerical order.
| Reference number of the standard | Title of the standard |
|---|---|
| EN 285:2015+A1:2021 | Sterilization – Steam sterilizers – Large sterilizers |
| EN 455-3:2023 | Medical gloves for single use – Part 3: Requirements and testing for biological evaluation |
| 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) |
| EN ISO 10993-10:2023 | Biological evaluation of medical devices – Part 10: Tests for skin sensitisation (ISO 10993-10:2021) |
| EN ISO 10993-12:2021 | Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021) |
| 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) |
| EN ISO 10993-17:2023 | Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023) |
| EN ISO 10993-18:2020 EN ISO 10993-18:2020/A1:2023 | Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020) |
| EN ISO 10993-23:2021 | Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021) |
| EN ISO 11135:2014, 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 11137-1:2015, EN ISO 11137-1:2015/A2:2019 | 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 11137-2:2015 EN ISO 11137-2:2015/A1:2023 | Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| EN ISO 11607-1:2020 EN ISO 11607-1:2020/A1:2023 | Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) |
| EN ISO 11607-2:2020 EN ISO 11607-2:2020/A1:2023 | Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) |
| EN ISO 11737-1:2018, 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) |
| 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) |
| EN ISO 13408-6:2021 | Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) |
| EN ISO 13485:2016, EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/A11:2021 | Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) |
| 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) |
| EN ISO 14971:2019, EN ISO 14971:2019/A11:2021 | Medical devices – Application of risk management to medical devices (ISO 14971:2019) |
| 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) |
| 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) |
| 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) |
| EN ISO 25424:2019, EN ISO 25424:2019/A1:2022 | 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) |
| EN IEC 60601-2-83:2020, 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 equipment |
IVDs under IVDR 2017/746
Arranged in numerical order.
| Reference number of the standard | Title of the standard |
|---|---|
| EN ISO 11135:2014, 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 11137-1:2015, EN ISO 11137-1:2015/A2:2019 | 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 11137-2:2015 EN ISO 11137-2:2015/A1:2023 | Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013) |
| EN ISO 11607-1:2020 EN ISO 11607-1:2020/A1:2023 | Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) |
| EN ISO 11607-2:2020 EN ISO 11607-2:2020/A1:2023 | Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) |
| EN ISO 11737-1:2018, 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) |
| 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) |
| EN ISO 13408-6:2021 | Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) |
| EN ISO 13485:2016, EN ISO 13485:2016/AC:2018, EN ISO 13485:2016/A11:2021 | Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) |
| EN ISO 14971:2019, EN ISO 14971:2019/A11:2021 | Medical devices – Application of risk management to medical devices (ISO 14971:2019) |
| 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) |
| 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) |
| EN ISO 25424:2019, EN ISO 25424:2019/A1:2022 | 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) |
Common Specifications
Like the use of Harmonised Standards, devices that are in conformity with an applicable Common Specification are “presumed to be in conformity with the requirements of this Regulation”.
Unlike Harmonized Standards, conformance to Common Specifications is essentially mandatory, unless the manufacturer “can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent hereto.”
Source Links
The full list of Common Specifications is available here: HERE
The link for each medical device and IVD Common Specification is available below:
- Commission Implementing Regulation (EU) 2020/1207: Common specifications for the reprocessing of single-use devices
- Commission Implementing Regulation (EU) 2022/2346: Common specifications for the groups of products without an intended medical purpose listed in Annex XVI of MDR 2017/745
- Commission Implementing Regulation (EU) 2022/1107: Common specifications for the following groups of Class D IVD devices
Medical Devices under MDR 2017/745
Arranged in numerical order.
| Implementing Regulation | Title of Common Specification |
|---|---|
| Commission Implementing Regulation (EU) 2020/1207 | Common specifications for the reprocessing of single-use devices – Lays down rules for the application of Article 17(3) of Regulation (EU) 2017/745, where national law has permitted reprocessing of single-use devices and a Member State has decided not to apply all of the rules relating to manufacturers’ obligations laid down in that Regulation as regards single-use devices that are reprocessed and used within a health institution. – Lays down rules where a Member State has chosen to apply Article 17(3) of Regulation (EU) 2017/745 also as regards single-use devices that are reprocessed by an external reprocessor. |
| Commission Implementing Regulation (EU) 2022/2346 | Common specifications for the groups of products without an intended medical purpose listed in Annex XVI of MDR 2017/745 – Contact lenses listed in Section 1 of Annex XVI to Regulation (EU) 2017/745. – Contact lenses containing tools, such as antenna or microchip, contact lenses which are active devices and other items intended to be introduced into or onto the eye are not covered by this Annex. – Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy, listed in Section 2 of Annex XVI to Regulation (EU) 2017/745. – Tattooing products, piercings and products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of fixation of body parts are not covered by this Annex. – This Annex does not apply to active implantable devices. – Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing, listed in Section 3 of Annex XVI to Regulation (EU) 2017/745. – This Annex only applies to the means for introduction into the body, for example syringes and dermarollers, where they are prefilled with the substances, combinations of substances or other items listed in Section 3 of Annex XVI to Regulation (EU) 2017/745. – This Annex does not apply to active devices. – Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty, listed in Section 4 of Annex XVI to Regulation (EU) 2017/745. – This Annex does not apply to active implantable devices. – High intensity electromagnetic radiation (for example infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment, listed in Section 5 of Annex XVI to Regulation (EU) 2017/745. – For the purposes of this Annex, skin resurfacing includes skin rejuvenation. – For the purposes of this Annex, tattoo removal includes removal of permanent make-up. – For the purposes of this Annex, other skin treatments include non-medical treatment of nevi flammei, haemangioma, teleangiectasia, pigmented skin areas, and scars that are not injury within the meaning of Article 2, point (1), second indent, of Regulation (EU) 2017/745. For example, this Annex applies to devices intended to treat acne scars, but it does not apply to devices for other acne treatment. This Annex does not apply to equipment using infrared optical radiation to warm the body or parts of the body and to sunbeds. – Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain as listed in Section 6 of Annex XVI to Regulation (EU) 2017/745. – Such equipment includes devices for transcranial alternating current stimulation, transcranial direct current stimulation, transcranial magnetic stimulation and transcranial random noise stimulation. – This Annex does not apply to invasive devices. |
IVDs under IVDR 2017/746
| Implementing Regulation | Title of Common Specification |
|---|---|
| Commission Implementing Regulation (EU) 2022/1107 | Common specifications for the following groups of Class D IVD devices – For Detection of Blood Group Antigens in the ABO, Rh, Kell, Duffy and Kidd Blood Group Systems – For Detection or Quantification of Markers of Human Immunodeficiency Virus (HIV) Infection – For Detection or Quantification of Markers of Human T-cell Lymphotropic virus (HTLV) infection. – For detection or quantification of markers of hepatitis C virus (HCV) infection – For Detection or Quantification of Markers of Hepatitis B virus (HPV) Infection – For Detection of Markers of Variant Creutzfeldt-Jacob (vCJD) Disease – For detection or quantification of markers of cytomegalovirus (CMV) infection – For detection or quantification of markers of Epstein-Barr virus infection (EBV) – For detection of markers of Treponema pallidum infection – For detection or quantification of markers of Trypanosoma cruzi infection – For Detection or Quantification of Markers of Severe Acute Respiratory Syndrome Coronavirus 2 Infection |
Pending Harmonized Standards
For the full list of forthcoming MDR/IVDR Standards, please read: List of Pending Standards to be Revised & Created (latest revision as of 27 May 2024)
