European Commission publishes harmonised standards in support of the MDR and IVDR

The European Commission adopted Implementing Decisions (EU) 2022/6 of 4 January 2022 and 2022/15 of 6 January 2022 regarding harmonised standards in support of Regulation (EU) 2017/745 (the "Medical Devices Regulation" - "MDR") and Regulation (EU) 2017/746 (the "In-vitro Diagnostic Medical Devices Regulation" - "IVDR") respectively. The references to harmonised standards contain, among others, the latest version of EN ISO 13485 standard, the most widely used management quality system standard in the medical devices industry.

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:

Medical Devices Regulation

Revised

Standards

Brief description

EN ISO 10993-9:2021

Biological evaluation of medical devices

EN ISO 10993-12:2021

EN ISO 13408-6:2021

Aseptic processing of health care products

EN ISO 14160:2021

Sterilization of health care products

EN ISO 15223-1:2021

Symbols to be used with information to be supplied by the manufacturer

EN ISO 17664:2021

Processing of health care products

Amended

EN ISO 11737-1:2018/A1:2021

Sterilization of health care products

EN ISO 13485:2016/A11:2021

Quality management systems

EN IEC 60601-2-83:2020/A11:2021

Particular requirements for the basic safety and essential performance of home light therapy equipment.

 

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:

In-vitro Diagnostic Medical Devices Regulation

Revised

Standards

Brief description

EN ISO 13408-6:2021

Aseptic processing of health care products

EN ISO 15223-1:2021

Symbols to be used with information to be supplied by the manufacturer

EN ISO 17511:2021

Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples

Amended

EN ISO 11737-1:2018/A1:2021

Sterilization of health care products

EN ISO 13485:2016/A11:2021

Quality management systems

 

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.

Contacts
Fabien Roy
Partner
Brussels
Gregoire Paquet
Associate
Brussels

 

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