The European Commission kickstarted 2022 with the publication in the Official Journal of the European Union (“OJEU”) of lists of harmonised standards in support of the medical devices regulations, namely the MDR and IVDR.
Following the European Commission's standardisation requests, the European Committee for Standardization ("CEN") and the European Committee for Electrotechnical Standardization ("Cenelec") revised existing harmonised standards and developed new versions to reflect the latest technical and scientific developments, and to cover the requirements set out in the MDR and IVDR.
The updated version of the most common standard for quality management systems for medical devices, that is EN ISO 13485:2016/A11:2021, is among the harmonised standards adopted in the context of both the MDR and IVDR.
Medical Devices Regulation (MDR)
By virtue of European Commission's Implementing Decision (EU) 2022/6 of 4 January 2022, the following references of 6 revised and 3 amended harmonised standards were adopted, as shown in the table below:
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Medical Devices Regulation
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Revised
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Standards
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Brief description
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EN ISO 10993-9:2021
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Biological evaluation of medical devices
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EN ISO 10993-12:2021
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EN ISO 13408-6:2021
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Aseptic processing of health care products
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EN ISO 14160:2021
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Sterilization of health care products
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EN ISO 15223-1:2021
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Symbols to be used with information to be supplied by the manufacturer
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EN ISO 17664:2021
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Processing of health care products
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Amended
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EN ISO 11737-1:2018/A1:2021
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Sterilization of health care products
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EN ISO 13485:2016/A11:2021
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Quality management systems
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EN IEC 60601-2-83:2020/A11:2021
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Particular requirements for the basic safety and essential performance of home light therapy equipment.
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With the addition of the harmonised standards above, the total number of harmonised standards published in the OJEU in support of the MDR now climbs to 14.
In-vitro Diagnostic Medical Devices Regulation (IVDR)
The European Commission further adopted Implementing Decision (EU) 2022/15 of 6 January 2022, adding 5 new references, comprising 3 revised and 2 amended versions of standards, to the list of harmonised standards in support of the IVDR, as shown in the table below:
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In-vitro Diagnostic Medical Devices Regulation
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Revised
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Standards
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Brief description
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EN ISO 13408-6:2021
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Aseptic processing of health care products
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EN ISO 15223-1:2021
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Symbols to be used with information to be supplied by the manufacturer
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EN ISO 17511:2021
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Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
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Amended
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EN ISO 11737-1:2018/A1:2021
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Sterilization of health care products
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EN ISO 13485:2016/A11:2021
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Quality management systems
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The publication of these standards brings the total of harmonised standards published in the OJEU in support of the IVDR to 9.
Conformity with harmonised standards
Conformity with harmonised standards, the references of which are cited in the OJEU, confers a presumption of conformity with the requirements of the MDR or IVDR that the relevant standard, or parts thereof, aims to cover. In other words, manufacturers may choose to comply with the harmonised standards published in the OJEU to demonstrate conformity with the requirements of the MDR or IVDR to which the standards are linked. However, the use of harmonised standards remains voluntary (with certain exceptions), meaning that manufacturers can demonstrate conformity with the relevant requirements by other means.
Next steps
The European Commission is expected to further expand the lists of harmonised standards in support of the MDR and IVDR in the coming months.
Our team monitors the developments and regularly advises clients on compliance with the requirements set out in the medical devices regulations and on use of standards. Please do not hesitate to reach out for more information.
Authored by Fabien Roy, Grégoire Paquet, and Nikoleta Kyriazopoulou.
