European Commission Updates Harmonised Standards Lists
by Alec Denniff, Medical Device Paralegal
The European Commission has published a second series of amendments to the original lists of harmonised standards in the Official Journal of the European Communities (OJ). A harmonised standard is a European standard developed by a recognised European Standards Organisation (CEN, CENELEC, ETSI).
Manufacturers may use harmonised standards listed in the OJ to demonstrate that their products comply with relevant EU legislation, such as the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Compliance with a harmonised standard provides a presumption of conformity with the requirements of the MDR or IVDR to which the standard releates. The presumption of conformity may apply to system or process requirements, now including the requirements that relate to quality management systems (QMS) and risk management.
The Commission published its first list of harmonised standards in support of the MDR in July 2021 (Commission Implementing Decision EU 2021/1182). The first list included five harmonised standards, mostly those relating to sterilisation and biological evaluation. The IVDR (Commission Implementing Decision EU 2021/1195) list contained four harmonised standards, also limited to sterilisation.
These lists were subsequently updated in January 2022. For the MDR, the updated list (Commission Implementing Decision EU 2022/6) added nine harmonised standards, the most notable being:
ISO 13485:2016 concerning Quality Management Systems,
IEC 60601 relating to medical electrical equipment, and
ISO 15233-1:2021 concerning symbols to be used with the information supplied by a manufacturer.
For the IVDR, the updated list (Commission Implementing Decision EU 2022/15) added five harmonised standards, including ISO 13485:2016 and ISO 15233-1:2021 and standards concerning sterilisation, aseptic processing and requirements for establishing metrological traceability of values.
The latest updates were published in May 2022: Commission Implementing Decision EU 2022/757 for the MDR, and Commission Implementing Decision EU 2022/729 for the IVDR. This added two harmonised standards to the MDR list – ISO 14971:2019 concerning risk management and EN 285:2015, concerning steam sterilisation. For the IVDR, only ISO 14971:2019 was added. The addition of ISO 14971:2019 as a harmonised standard is an important addition for manufacturers and notified bodies. Where compliance with the standard is ensured, it will now offer a presumption of conformity to many requirements of the MDR or IVDR relating to risk.
Current Harmonised Standards Lists
Whilst not complete, the consolidated list of harmonised standards in support of the MDR now contains 17 standards, whilst the IVDR holds 11. Those lists may be found here for the MDR, and here for the IVDR.
17 May 2022