Further amendment to lists of harmonised standards with presumption of conformity to European medical devices regulations

European Commission updates list of harmonised standards in Official Journal

The European Commission has published the second amendments to the lists of harmonised standards in the Official Journal of the European Communities (OJ). Harmonised standards listed in the OJ provide a presumption of conformity with the with relevant requirements of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) covered by those standards or applicable parts of standards. The presumption of conformity also applies to system or process requirements, including those requirements relating to quality management systems and risk management. European standards that are harmonized include a European Foreword and Annex Zs that describe the relationship between the requirements of the standard and the regulatory requirements in the European Regulations that are applicable to the scope of that standard.

The first list of harmonized standards for the MDR was published in July 2021 as Commission Implementing Decision EU 2021/1182 for the MDR and EU 2021/1195 for the IVDR.  These lists were updated with additional standards in January 2022 with amendments to the original decision as EU 2022/6 for the MDR and EU 2022/15 for the IVDR. The latest updates were published as further amendments to the original decision in May 2022. These latest updates are EU 2022/757 for the MDR and EU 2022/729 for the IVDR.

Both amendments add EN ISO 14971:2019/A.11:2021 - Medical devices – Application of risk management to medical devices – to the list of standards with a presumption of conformity. This is an important addition for manufacturers and notified bodies. The amendment A.11 to EN ISO 14971 introduced European Annex Zs to the standard mapping the clauses of the standard against the General Safety and Performance Requirements in Annex I of the regulations.

In addition, both amendments modify the list with reference to EN ISO 13485:2016 - Medical devices – Quality management systems – Requirements for regulatory purposes. The change in reference to EN ISO 13485 is administrative and explained as for reasons of legal certainty. The original listing of EN ISO 13485 did not reference the corrigendum to that standard in EN ISO 13485:2016/AC:2018. This corrigendum corrects only formal aspects of the European foreword and of the European Annex Zs, without affecting the substance of the standard. In addition, the cited amendment in the OJ, EN ISO 13485:2016/A11:2021, actually replaced the Annex Zs corrected in the 2018 corrigendum, leaving only corrections in the European Foreword that were not changed by the 2021 amendment as applicable.

EN ISO 14971 and EN ISO 13485 are the only two standards included for the IVDR giving 11 standards on the updated, consolidated list. For the MDR, one further additional standard is added to the list of harmonised standards providing a presumption of conformity. This standard is EN 285 - Sterilization – Steam sterilizers – Large sterilizers, giving 17 standards on the consolidated list.