Relationship between the revised risk management standard and European regulatory requirements

EN ISO 14971 published without the European Annex Zs

Development of the revised version of ISO 14971 - Medical devices — Application of risk management to medical devices - has been followed with interest and much discussed. The new edition was finally published in December 2019. In Europe, the new edition was adopted as EN ISO 14971:2019.

The European Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) have specific roles for harmonised standards in demonstrating conformity. Article 8 in each regulation indicates that harmonized standards are those referenced in the Official Journal of the European Union. Devices in conformity with relevant harmonized standards are presumed to be in conformity with the requirements of the regulation covered by those standards. Additionally, the presumption of conformity also applies to system or process requirements, including those requirements relating to risk management.

In order for a standard to be harmonized under the regulations, a standardization request has to be agreed between the European Commission and the European Standards organizations – CEN and CENELEC. A draft of this standardization request was published by the European Commission.  EN ISO 14971 is on the list of standards to be harmonized in this draft standardization request. The deadline for adoption of most of the listed standards is 27 May 2024, but there is a small number of standards that have a higher priority. Those listed standards with a deadline for adoption of 26 May 2020 are generally horizontal standards that apply to a wide range of manufacturers. These include EN ISO 14971.

Harmonized European standards include European Annex Zs that show the relationship between the requirements of the standard and the regulatory requirements in the European Directives or Regulations that are applicable to the scope of that standard.  The final draft of EN ISO 14971 circulated for ballot included drafts for five European Annexes Z. These showed the relationship between the requirements of the standard and the regulatory requirements in the European Directives and Regulations for medical devices:

• Draft Annexes ZA, ZB and ZC showed the relationships with the Directives for medical devices. These Annexes incorporated some modifications from their equivalents in EN ISO 14971:2012 in the light of the changes made in the new edition of the standard.
• Draft Annexes ZD and ZE showed the relationships between EN ISO 14971:2019 and Chapter 1 of Annex I of the MDR and IVDR respectively. Annex I of the MDR and IVDR sets out the General Safety and Performance Requirements (GSPRs). Chapter 1 of Annex I, General Requirements, defines the regulatory requirements in Europe for a risk management system.

However, these Annexes Z were not included in the published text. This was because comments received from the independent review of the Annex Zs were taking time to resolve. Rather than delay publication of the technical content of the standard, and avoid the possibility of the international and European versions of the standard being published in different years, it was agreed to proceed to publication of the European adoption without including the Annexes Z. The intention is to include the agreed versions of these Annexes in a European amendment to the standard.

Understanding the current expectations for a risk management system is a critical element of meeting regulatory requirements. The content of EN ISO 14971:2019 describes the state of the art for risk management and provides important support in complying with regulations internationally. These documents can be important tools in transitioning to the MDR and IVDR, even without the European annex Zs. As you are revising your Technical Documentation to the new European requirements, it will be essential to make sure that your risk management documentation, including risk management plans and risk management files, meet current expectations.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development