The European standard EN ISO 14971:2019 with its amendment A11:2021 is finally cited in the Official Journal of the European Union (OJEU) as a harmonized standard.
The European standard EN ISO 14971:2019 with its amendment A11:2021 is finally cited in the Official Journal of the European Union (OJEU) as a harmonized standard in support of the European regulations (EU) 2017/745 for medical devices and (EU) 2017/746 for in vitro diagnostic medical devices. The amendment A11 is specific for the EU; it adds Annexes Z that provide information about which parts of the legislation are addressed by the standard. Amendment A11 does NOT modify the normative part of the referenced ISO 14971. The citations were made public by Commission Implementing Decisions 2022/757 for MDR and 2022/729 for IVDR, both published in May 2022.
The standard (EN) ISO 14971 provides terminology, principles, and a process for applying risk management to medical devices. The standard was updated to align with changes in several regulations worldwide with an increased focus on benefits for the patient and on the balance between those benefits and the residual risks. The standard provides a complete process for the identification, assessment, control, and monitoring of all risks associated with medical devices.
Recognition of EN ISO 14971 as a harmonized standard in support of the European Medical Device Regulations marks an important milestone. Harmonization and citation in the OJEU confirm that the risk management process of EN ISO 14971 represents the generally acknowledged state of the art. Furthermore, it gives a guarantee to medical device manufacturers that this standard can be used to demonstrate compliance with the risk management requirements of MDR and IVDR. This principle is called the “presumption of conformity” of using harmonized standards.