European standard for risk management of medical devices is amended

EN ISO 14971 amended to show relationship with European Regulations for medical devices

A European amendment to EN ISO 14971 - Medical devices - Application of risk management to medical devices was published in December 2021. The amendment is designated EN ISO 14971:2019+A11:2021. The amendment replaces the European Foreword and adds two new Annex Zs - designated ZA and ZB – which show the relationship between the clauses of the standard and the requirements of the Medical Devices Regulation ((EU) 2017/745 ) (MDR) and In vitro Diagnostic Medical Devices Regulation ((EU) 2017/746) (IVDR).

The technical content of the standard has not been changed and is identical with ISO 14971:2019. The European adoption of ISO 14971:2019 did not contain any Annex Zs showing the relationship between the standard and the requirements in the MDR and IVDR or the three European Directives for medical devices – those being the Directives for active implantable devices, medical devices and in vitro diagnostics. While the 2012 edition of EN ISO 14971 did have Annex Zs for each of the three Directives, the extent of coverage indicated in these Annex Zs was not particularly strong and there was a long list of perceived content deviations. The MDR and IVDR have more detailed requirements for the risk management process compared with the previous Directives. The new Annex Zs in EN ISO 14971:2019+A11:2021 show a stronger relationship between the standard and the risk management process required in the regulations.

The introductory text to the new Annex Zs indicates that in applying the standard in the context of the MDR and IVDR:

• the scope is limited to medical devices and accessories for a medical device as defined in the regulations and to products regulated as devices under the regulations;
• if there are differences between definitions in the standard and terms defined in the regulations, the definitions in the regulations take precedence; and,
• the manufacturer’s policy for establishing criteria for risk acceptability has to ensure that the criteria comply with the General Safety and Performance Requirements (GSPRs) of the regulations.

Tables in Annex ZA and ZB show the relationship between the GSPRs in Annex I of each regulation with the clauses of EN ISO 14971. The tables cover the General Requirements in Chapter 1 of Annex I. In particular, the tables address:

• GSPR 3 regarding the manufacturer’s risk management system;
• GSPR 4 regarding risk control measures;
• GSPR 5 regarding eliminating or reducing risks;
• GSPR 8 regarding known and foreseeable risks, and undesirable side-effects; and,
• GSPR 9 of the MDR regarding devices without a medical purpose.

The tables indicate that, in regard to some of the requirements of the regulations, the standard covers the process requirements but not the device-specific execution of the process.

Publication of the amendment to EN ISO 14971 opens the door to the standard being listed in future in the Official Journal of the European Union as providing a presumption of conformity with the requirements of the European Regulations, with the extent that the requirements are covered being described in the Annex Zs.

BSI have published the amendment to the European standard as BS EN ISO 14971:2019+A11:2021. The BSI adoption does not include an additional national annex giving the correlation between the standard and the relevant UK legislation, i.e., the UK MDR 2002, as amended. A national annex, designated Annex NZ, was included in BS EN ISO 13485:2016 + A11:2021 as a trial to help establish the process that might be used for preparing any necessary national annexes. It is possible that a national Annex NZ will be added to BS EN ISO 14971:2019+A11:2021 in future.