New MDR/IVDR standardization request adds standards, moves deadlines
The European Commission recently adopted its latest version of the medical device and diagnostics standardization request, with help from European standards organizations. These are the lists of national and international standards the Commission plans to harmonize with its device and diagnostics regulations. The new request adds a significant number of standards to the request but also pushes back the deadlines for when most of them need to be updated – by four years.
A quick background on harmonized standards
- What is a standard and how is it used? According to the International Standards Organization (ISO), “standards are the distilled wisdom of people with expertise in their subject matter and who know the needs or the organizations they represent – people such as manufacturers, sellers, buyers, customers, trade associations, users, or regulators.” Standards may describe quality management systems or specific product requirements, and they cover a wide range of sectors and fields. Vertical standards apply to a particular type of product, while horizontal standards apply across industries.
- A harmonized standard is one that the European Commission has published in the E.U.’s Official Journal (OJEU). These standards allow users to presume conformity with the essential requirements of previous medical device and IVD directives – the medical device directive (MDD), active implantable medical devices directive (AIMDD) and IVD directive (IVDD), respectively – or the general safety and performance requirements of the medical device and diagnostics regulations (MDR and IVDR). This is similar to the situation in the U.S., where the FDA has a database of “recognized consensus standards” for sponsors to use to show their device is safe and effective or substantially equivalent.
- Non-harmonized standards are ones that have not been published in the OJEU; they may still be used but do not automatically provide presumption of conformity and their use will need robust justification.
- Under the previous MDD, AIMDD and IVDD, the Commission harmonized more than 300 different standards. These standards described requirements for particular medical devices (e.g., steam sterilizers, medical gloves, non-invasive sphygmomanometers) and IVDs, as well as processes to demonstrate safety or efficacy such as different methods of sterilization, good clinical practice, and biological evaluation of medical devices (also known as “biocompatibility”). This list of standards has been updated as standards themselves were updated, with the most recent updates occurring in April 2021.
- But standards harmonized under the directives may not be used to show compliance with the new Medical Device Regulation, which replaced the MDD. As stated in Commission Implementing Decision (EU) 2020/437, the last list of consolidated harmonized standards published for MDD “may not be used to confer presumption of conformity with the requirements of [MDR].”
- Standardization requests are requests issued by the Commission and directed to European standards organizations to draft or modify European standards, according to Article 10 of Regulation (EU) No 1025/2012. In the request, the Commission asks for the standard to be completed by a certain deadline, and the standards organizations have one month to accept the request. The E.U. has three European standardization organizations – the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (Cenelec) and the European Telecommunications Standards Institute (ETSI). These organizations are “responsible for developing and defining voluntary standards at the European level.” The Vienna Agreement describes the cooperation between ISO and CEN, “drawn up with the aim of preventing duplication of effort and reducing time when preparing standards.”
- Quick note on European norms and normative references: According the Institute of Electrical and Electronics Engineers (IEEE), normative references “are those documents that contain material that must be understood and used to implement the standard.” The European Committee for Standardization (CEN) defines normative references as those “to which reference is made in the standard in such a way as to make it indispensable for the application of the standard.” CEN instructs that for European Standards or European Norms (EN), the EN version of standards from other organizations such as ISO, “shall not contain normative references to: directives, their essential requirements and/or elements of directives; documents that are not publicly available; documents which only serve for information; documents only used as a reference during the preparation of the standard.” However, these documents can be listed in a bibliography to the standard – “Annex Z” in standards that apply to MDR and IVDR. In effect, this adds “EN” to the front of ISO standards, making them EN ISO standards
An initial standardization request set up the list of standards the Commission wanted to harmonize to the MDR and the IVDR
- In April, 2021, the Commission released its initial (accepted) standardization request to CEN and Cenelec, the main European standards organization, after an initial false start. Recital 6 of the request noted that “standards developed at the international level by [ISO] and the International Electrotechnical Commission (IEC)…need to be adopted as harmonised standards by [CEN] and [Cenelec] after adapting them to the Union legal framework,” as well as new standards that the organizations would need to draft against the new regulations.
- The request included separate lists of standards to both modify and create. It required CEN and Cenelec to submit a joint work program by May 28, 2021 and report annually to the Commission on progress on the request. It also noted that if CEN or Cenelec don’t accept a standardization request within a month of receiving it, “the request may not constitute a basis for the standardisation activities.” It also listed an expiry for the request of December 31, 2024.
- The deadline for adoption of all standards listed in the two annexes was May 27, 2024 (see Annex I). Annex I covered standards for the MDR and Annex II standards for the IVDR. Within each annex, two tables listed the standards needing to be modified (Table 1) and new standards (Table 2) the Commission wanted created. Annex III outlined the requirements for the requested standards revisions – that they support the general safety and performance requirements in the MDR and IVDR and any differences in definitions between the standards and regulations be addressed in an Annex Z to the standard.
The Commission recently issued a new draft standardization request to add more standards to be harmonized against the MDR and IVDR
- The standardization request modifies the previous requests. Request M/575 Amd 2 – C(2024)3371 modifies Implementing Decision C(2021)2406, which repealed C(2020)2532 (M/565) and which has been amended by C(2023)694 and C(2024)3371. All requests are adopted by the Commission and addressed to the European standardization organizations, in this case CEN and Cenelec.
- The new request has two goals – modifying the Commission standards request list for MDR and IVDR and modifying the timelines to harmonize standards and issue reports. The standards organizations CEN and Cenelec notified the Commission that the standardization request needed to be updated again, based on scientific and technical progress. The new request consists of several parts: a list of standards that need to be revised, new standards that need to be added and standards that need to be removed and replaced.
- The new request would also push back certain deadlines, due to “limitations in resources affecting the activities of the relevant technical committees in CEN and Cenelec at the European level, and of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) at the international level, as well as to some delays in the operation of the Harmonised Standards (HAS) consultant system for the assessment of draft harmonised standards.”
- To support the extension, the request also noted the extended transitional periods for medical devices and diagnostics though December 31, 2028. Based on this, CEN and Cenelec want to extend the validity of the request to December 31, 2028, the deadline for adoption of some of the standards within the list to May 27, 2028, and issue the joint final report by June 30, 2028.
- Replacement, rather than redlining, of the annexes: “Due to the large number of amendments in Annexes I and II to Implementing Decision C(2021)2406, those Annexes should, in the interest of legal clarify and rationality, be replaced.”
- Standards added to the amended request that need revision to meet MDR requirements: The new standardization request would add 22 standards needing modification in order to align with the MDR, thirteen of which regard chemical disinfectants and antiseptics, five regarding various types of respiratory equipment, and four relating to medical and laboratory electrical equipment. See Table 1 below for the complete list of standards added to the request that would need modification to meet MDR requirements.
Table 1: Standards requiring modification that would be added to the MDR/IVDR standardization request (Annex I Table 1):
Topic | Standard | Title |
Chemical disinfectants and antiseptics | EN 13624 | Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area – Test method and requirements (phase 2, step 1) |
EN 13727 | Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of bactericidal activity in the medical area – Test method and requirements (phase 2, step 1) | |
EN 14348 | Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectant in the medical area including instrument disinfectants – Test methods and requirements (phase 2, step 1) | |
EN 14476 | Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of virucidal activity in the medical area – Test methods and requirements (phase 2, step 1) | |
EN 14561 | Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area – Test method and requirements (phase 2, step 2) | |
EN 14562 | Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area – Test methods and requirements (phase 2, step 2) | |
EN 14563 | Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area – Test method and requirements (phase 2, step 2) | |
EN 16615 | Chemical disinfectants and antiseptics – Quantitative test method for the evaluation of bactericidal and yeasticidal activity on non-porous surfaces with mechanical action employing wipes in the medical area (4-field test) – Test method and requirements (phase 2, step 2) | |
EN 16616 | Chemical disinfectants and antiseptics – Chemical-thermal textile disinfection – Test method and requirements (phase 2, step 2) | |
EN 16777 | Chemical disinfectants and antiseptics – Quantitative non-porous surface test without mechanical action for the evaluation of virucidal activity of chemical disinfectants used in the medical area – Test method and requirements (phase 2, step 2) | |
EN 17111 | Chemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of virucidal activity for instruments used in the medical area – Test method and requirements (phase 2, step 2) | |
EN 17126 | Chemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants in the medical area – Test method and requirements (phase 2, step 1) | |
EN 17387 | Chemical disinfectants and antiseptics – Quantitative test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants in the medical area on non-porous surfaces without mechanical action – Test method and requirements (phase 2, step 2) | |
Sleep apnea | EN ISO 17510 | Medical devices – Sleep apnoea breathing therapy – Masks and application accessories |
Breathing system filters for anesthetic and respiratory use | EN ISO 23328-1 | Breathing system filters for anaesthetic and respiratory use – Part 1: Salt test method to assess filtration performance |
EN ISO 23328-2 | Breathing system filters for anaesthetic and respiratory use – Part 2: Non-filtration aspects | |
Anesthetic and respiratory equipment | EN ISO 23747 | Anaesthetic and respiratory equipment – Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans |
EN ISO 26782 | Anaesthetic and respiratory equipment – Spirometers intended for the measurement of time forced expired volumes in humans | |
Medical electrical equipment | EN IEC 60601-2-22 | Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
EN IEC 60601-2-57 (draft) | Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostics, monitoring, cosmetic and aesthetic use | |
EN IEC 80601-2-77 | Medical electrical equipment – Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment | |
Laboratory electrical equipment | EN IEC 61010-2-040 | Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials |
- New standards to be added to the standardization request: If approved, the new standardization request would add 25 standards to the list needing to be drafted to support the MDR, 11 of which relate to medical electrical equipment. The remaining 14 address myriad topics, one of the most important being clinical evaluation of medical devices (EN ISO 18969). Three relate to sterilization and disinfection, and the remaining ten cover a number of technologies – see Table 2 below for the complete list.
Table 2: New standards that would be added to the MDR/IVDR standardization request (Annex I Table 2):
Topic | Standard | Title |
Anesthetic reservoir bags | EN ISO 5362 | Anaesthetic reservoir bags |
Anesthetic and respiratory equipment | EN ISO 5367 | Anaesthetic and respiratory equipment – Breathing sets and connectors |
ISO 17256 | Anaesthetic and respiratory equipment – Respiratory therapy tubing and connectors | |
ISO 18190 | Anaesthetic and respiratory equipment – General requirements for airways and related equipment | |
ISO 19211 (draft) | Anaesthetic and respiratory equipment – Fire-activated oxygen shut-off devices for use during oxygen therapy | |
EN ISO 20789 | Anaesthetic and respiratory equipment – Passive humidifiers | |
Medical gas pipeline systems | EN ISO 7396-3 (draft) | Medical gas pipeline systems – Part 3: Proportioning units for the production of synthetic medical air |
Lung ventilators | EN ISO 10651-5 | Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 5: Gas-powered emergency resuscitators |
Sterilization | EN ISO 11140-6 | Sterilization of health care products – Chemical indicators – Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers |
Washer disinfectors | EN ISO 15883-5 | Washer-disinfectors – Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy |
Plume evacuation | EN ISO 16571 | Systems for evacuation of plume generated by medical devices |
Liquid oxygen systems | EN ISO 18777-1 (draft) | Transportable liquid oxygen systems for medical use – Part 1: Common requirements and particular requirements for base units |
EN ISO 18777-2 (draft) | Transportable liquid oxygen systems for medical use – Part 2: Portable units | |
Clinical evaluation | EN ISO 18969 (draft) | Clinical evaluation of medical devices |
Medical electrical equipment | EN ISO 80601-2-55 | Medical electrical equipment – Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
EN ISO 80601-2-61 | Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | |
EN ISO 80601-2-67 | Medical electrical equipment – Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment | |
EN ISO 80601-2-70 | Medical electrical equipment – Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment | |
EN ISO 80601-2-72 | Medical electrical equipment – Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients | |
EN ISO 80601-2-74 | Medical electrical equipment – Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment | |
EN ISO 80601-2-79 | Medical electrical equipment – Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment | |
EN ISO 80601-2-80 | Medical electrical equipment – Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency | |
EN ISO 80601-2-85 | Medical electrical equipment – Part 2-85: Particular requirements for the basic safety and essential performance of cerebral tissue oximeter equipment | |
EN ISO 80601-2-87 | Medical electrical equipment – Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators | |
EN ISO 80601-2-90 | Medical electrical equipment – Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment |
- Standards to be removed from the standardization request: The updated request proposes three standards to be removed from the original request, two of which were on the IVDR list of standards and one that was on the MDR list. See Table 3 below for details on the standards and reasons for removal.
Table 3: Standards proposed to be removed from the standardization request (Annex I and Annex II, both tables)
Standard | Description | Reason |
EN 455-5 | Medical gloves for single use – Part 5: Extractable chemical residues | No longer will include MDR requirements; removed from Annex I Table 2 (new standards) |
EN 61010-1 | Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements | Replaced by EN 61010-2-101; removed from Annex II Table I (existing standards) for IVDR. |
ISO 18362 | Manufacture of cell-based health care products — Control of microbial risks during processing | Intended to exclude IVDs; removed from Annex II Table 2 for IVDR. |
- What Annex III does: Annex III of Implementing Decision C(2021)2406 set out the requirements for harmonized standards in order to support the safety and performance of products governed by the MDR and the IVDR. Requirements included the content of the standard (e.g., detailed technical, scientific and method specifications) and how they should be structured and how the clauses and sub-clauses related to the MDR and IVDR (described in Annex Z of each standard). Any differences in definitions between the standard and the regulations should be described in informative Annex Z and in the foreword of the standard; the regulation prevails over any standard. Where standards describe the meaning of a symbol, this information should be publicly available. Part B laid out specific requirements for certain standards, and included a biological evaluation standard (EN ISO 10993-17) and how to calculate exposure, EN, the medical device symbols standard (EN ISO 15223-1), needle sharps protection (EN ISO 23908) and health software (EN 82304-1)
- Updates to Annex III: The proposed update requires a modification to the symbols standard, EN ISO 15223-1, changing the symbol indicating the authorized representative from EC REP to EU REP.
Discussion and analysis:
- The new standardization request would add 22 standards needing modification to align with the MDR and 25 that would need to be created. The complete list of standards needing modification (Annex I Table 1) now stands at 226 and the list needing creation at 51 (Annex I Table 2). The IVDR lists (Annex II) didn’t change significantly except for some of the deadlines; the total number of IVD standards needing modification would be 45 (Annex II Table 1) and the list of new standards needing to be created would be 4 (Annex II Table 2). The request would remove three standards from the lists, two from the IVD list and one from the MDR list. Because of the significant updates, the new request would replace the three annexes of C(2021)2406, rather than list the additions only.
- Important added standards for device and diagnostics manufacturers will likely be the ones addressing chemical disinfectants and antiseptics. The new request would add 13 new standards covering different types of tests on different surfaces, and testing for different types of activity – e.g., fungicidal, yeasticidal, bactericidal, etc. The request would also add five or so standards that address different types of breathing and respiratory equipment. A few other standards of interest address medical electrical equipment and electrical safety. These, once harmonized, give sponsors a significantly reinforced arsenal of standards to allow presumption of conformity with the MDR and IVDR’s general safety and performance requirements.
- Perhaps more importantly, the revised request would give the European standard organizations four more years in which to update and create most of the requested standards. As stated in the request, the reasons for pushing back the deadline include lack of resources on the standards team and the 2023 MDR transition extension. More notable than the hundreds of standards with extended deadlines may be the 42 MDR standards that retain the original deadline of May 2024, listed in Table 4 below:
Table 4: List of MDR requested standards needing revision where the deadline did NOT change and would remain May 2024 (Annex I Table 1):
Number | Title | Harmonized yet? |
EN 285 | Sterilization – Steam sterilizers – Large sterilizers | YES |
EN 556-1 | Sterilization of medical devices – Requirements for medical devices to be designated “STERILE” – Part 1: Requirements for terminally sterilized medical devices | NO |
EN 556-2 | Sterilization of medical devices – Requirements for medical devices to be designated ”STERILE” – Part 2: Requirements for aseptically processed medical devices | NO |
EN 1865-2 | Patient handling equipment used in road ambulances – Part 2: Power assisted stretcher | NO |
EN ISO 10993-9 | Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products | YES |
EN ISO 10993-10 | Biological evaluation of medical devices – Part 10: Tests for skin sensitization | YES |
EN ISO 10993-12 | Biological evaluation of medical devices – Part 12: Sample preparation and reference materials | YES |
EN ISO 10993-15 | Biological evaluation of medical devices – Part 15: Identification and quantification of degradation products from metals and alloys | YES |
EN ISO 10993-17 | Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents | YES |
EN ISO 10993-18 | Biological evaluation of medical devices – Part 18: Chemical characterization of materials | YES |
EN ISO 11135 | Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices | YES |
EN ISO 11137-1 | Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | YES |
EN ISO 11137-2 | Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose | YES |
EN ISO 11607-1 | Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems |
YES |
EN ISO 11607-2 | Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes | YES |
EN ISO 11737-1 | Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products |
YES |
EN ISO 11737-2 | Sterilization of medical devices – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | YES |
EN ISO 12870 | Ophthalmic optics – Spectacle frames – Requirements and test methods | NO |
EN ISO 13408-1 | Aseptic processing of health care products – Part 1: General requirements | NO |
EN ISO 13408-6 | Aseptic processing of health care products – Part 6: Isolator systems | YES |
EN ISO 13485 | Medical devices – Quality management systems – Requirements for regulatory purposes | YES |
EN ISO 14160 | 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 | YES |
EN ISO 14971 | Medical devices – Application of risk management to medical devices | YES |
EN ISO 17664 (-1, -2) | Sterilisation of medical devices – Information to be provided by the medical device manufacturer for the processing of medical devices | YES |
EN ISO 17665 | Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices | NO |
EN ISO 18562-1 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 1: Evaluation and testing within a risk management process | NO |
EN ISO 18562-2 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 2: Tests for emissions of particulate matter | NO |
EN ISO 18562-3 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 3: Tests for emissions of volatile organic compounds (VOCs) | NO |
EN ISO 18562-4 | Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4: Tests for leachables in condensate | NO |
EN ISO 21535 | Non-active surgical implants – Joint replacement implants – Specific requirements for hip-joint replacement implants | NO |
EN ISO 21536 | Non-active surgical implants – Joint replacement implants – Specific requirements for knee-joint replacement implants | NO |
EN ISO 22675 | Prosthetics – Testing of ankle-foot devices and foot units – Requirements and test methods | NO |
EN ISO 25424 | Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices | YES |
EN 60118-0 | Electroacoustics – Hearing aids – Part 0: Measurement of the performance characteristics of hearing aids | NO |
EN IEC 60601-2-2 | Medical electrical equipment – Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories | NO |
EN 60601-2-10 | Medical electrical equipment – Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators | NO |
EN 60601-2-33 | Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis | NO |
EN 60601-2-45 | Medical electrical equipment – Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices | NO |
EN 60601-2-54 | Medical electrical equipment – Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | NO |
EN IEC 60601-2-57 | Medical electrical equipment – Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use | NO |
EN IEC 60601-2-75 | Medical electrical equipment – Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment | NO |
EN IEC 60601-2-83 | Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment | YES |
- More than half of the standards still showing a 2024 deadline in the annexes are late now. Of those 42 MDR requested MDR standards retaining the 2024 deadlines, while 19 of them have already been harmonized, 21 still have not been – see Table 4 above. The 19 standards that have been harmonized are important ones, largely on biocompatibility and sterilization. But 21 standards aren’t harmonized and are now overdue, as the deadline was May 27, 2024. Just one of the new standards needing to be created has been harmonized, a biological evaluation standard for tests for irritation (ISO 10993-23). The other two haven’t yet been harmonized, though all show a deadline for adoption of May 27, 2024 – see Table 5 below:
Table 5: List of new harmonized MDR standards needing creation where the deadline didn’t change and would remain May 2024 (Annex I Table 2):
Number | Title | Harmonized |
prEN 1865-6 | Patient handling equipment used in road ambulances – Part 6: Power chairs | NO |
ISO 10993-23 | Biological evaluation of medical devices – Part 23: Tests for irritation | YES |
ISO/DIS 80369-2 | Small-bore connectors for liquids and gases in healthcare applications – Part 2: Connectors for respiratory applications | NO |
- Virtually all IVD requested standards are also part of the MDR lists. Nearly all of the IVD standards needing to be modified (Annex II Table 1) that retain the 2024 deadline overlap with the MDR harmonized standards. There is one standard unique to IVDs that still has a 2024 deadline: EN ISO 17511 In vitro diagnostic medical devices – requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples. This standard has already been harmonized under the IVDR.
- Discrepancies in the request: Though the standards organizations would give themselves until 2028 to update EN 455-3 on requirements for biological testing on medical gloves, this standard has already been harmonized. Another discrepancy is the symbols standard, ISO 15223-1. In the new standardization request, this standard has a deadline of 2024 for IVDR (Annex II) but 2028 for MDR (Annex I). That discrepancy is almost certainly an oversight, and since that standard is already on the harmonized list, presumably 2024 is the correct deadline for both Annexes.
- Harmonized standards continue to be one of the pieces of MDR and IVDR infrastructure that aren’t yet completely built out. Of the 277 standards planning to be harmonized under MDR per the standardization request, just 25 standards have been harmonized to date (note – the MDR harmonized standards list has 26 line items but one of the standards is repeated). This represents under 10% completion. Diagnostics are further along though with significantly fewer standards overall – with 14 standards harmonized on its wish list of 49 standards, which is nearly 30% of the way. And this completely sidesteps the question about harmonized standards vs. state of the art, something AgencyIQ has discussed before.
To contact the author of this item, please email Corey Jaseph ( cjaseph@agencyiq.com).
To contact the editor of this item, please email Alexander Gaffney ( agaffney@agencyiq.com)
Key Documents and Dates
- Standardization request M/575 Amd 2 – C(2024)3371, adopted by the Commission on May 27, 2024.
- Direct link: Main document.
- Direct link to annexes: Annex 1 of 1.