The European Commission has published in the Official Journal of the European Communities (OJ) the second amendments to the lists of harmonized standards. The harmonized standards listed in the OJ provide a presumption of conformity with the relevant requirements of the Medical Device Regulation ( MDR ) and the In Vitro Diagnostic Medical Device Regulation ( IVDR) covered by those standards or applicable parts of standards. The presumption of conformity also applies to system or process requirements, including those related to quality management systems and risk management.
Harmonized European standards include a European premise and Annex Z that describe the relationship between the requirements of the standard and the normative requirements of European regulations applicable to the scope of that standard.
The first list of harmonized standards for MDR was published in July 2021 as Commission Implementing Decision EU 2021/1182 for MDR and EU 2021/1195 for IVDR. These lists were updated with additional standards in January 2022 with amendments to the original decision as EU 2022/6 for MDR and EU 2022/15 for IVDR. The latest updates were published as additional 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 presumption of conformity. This is an important addition for manufacturers and notified bodies. Amendment A.11 to EN ISO 14971 introduced the European Annex Zs to the standard by mapping the clauses of the standard to the general safety and performance requirements in Annex I of the regulation.
In addition, both amendments change the list by reference to EN ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes . The amendment with reference to EN ISO 13485 is administrative and explained for reasons of legal certainty.
The original listing of EN ISO 13485 did not refer to the corrigendum of this standard in EN ISO 13485:2016/AC:2018. This corrigendum only corrects formal aspects of the European premise and the European Annex Zs, without affecting the substance of the standard. Furthermore, the aforementioned OJ amendment, EN ISO 13485:2016/A11:2021, effectively replaced Annex Z corrected in the 2018 corrigendum, leaving only the corrections in the European preface that were not changed by the 2021 amendment as far as applicable.
EN ISO 14971 and EN ISO 13485 are the only two standards included for IVDR providing 11 standards in the updated and consolidated list. For MDR, an additional standard is added to the list of harmonized standards that provide a presumption of conformity. This standard is EN 285 – Sterilization – Steam Sterilizers – Large Sterilizers , which provides 17 standards in the consolidated list.
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