The amendment replaces the European foreword and adds two new Annexes – ZA and ZB – stating the relationship between the clauses of the standard and the requirements of the Medical Devices Regulation (MDR (EU) 2017/745) and In Vitro Diagnostics Regulation (IVDR (EU) 2017/746).
The MDR and IVDR present more detailed requirements for the risk management process compared with the previous Directives. On the whole, the harmonization of ISO 14971:2019 as EN ISO 14971:2019+Amd 11:2021 is great news for the Medical Device manufacturer as it shows a stronger relationship between the standard and the risk management process required in the Regulations.
There are no content deviations in the Z Annexes of EN ISO 14971:2019+A11:2021. The Z Annexes state that once the standard has been published in the OJEU, compliance with the standard will give a presumption of conformity with the relevant General Safety and Performance Requirements (GSPRs) of the MDR and IVDR.
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. In particular, the tables address:
– GSPR 3 regarding the manufacturer’s risk management system;
– GSPR 4 regarding risk control measures;
– GSPR 5 regarding elimination or reduction of risks;
– GSPR 8 regarding known and foreseeable risks, and undesirable side-effects; and,
– GSPR 9 of the MDR regarding devices without a medical purpose.
In applying the standard considering new Annex Zs , it is important to note that:
– 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;
– The scope of application is limited to medical devices, accessories for a medical device as defined in the regulations and to products regulated as devices under the regulations;
– Z Annexes contain a number of explanatory notes stating that the manufacturer must comply with certain requirements of the MDR and IVDR which override any content of the standard;
– Annex ZA states that usability-specific aspects of applicable GSPRs are not covered. IEC 62366 covers usability of Medical Devices and it is expected to be harmonised in due course;
– The risk management process must comply with the requirement in the regulations that risks have to be reduced as far as possible and the manufacturer’s policy for establishing criteria for risk acceptability has to comply with the GSPRs of the regulations.
- EN ISO 14971:2019+A11:2021, on application of risk management to medical devices