Risk Management in EN ISO 14971 2019 Overview:
Two years ago, EN ISO 14971 2019 Medical Devices – Application of Risk Management to Medical Devices was released. Harmonized Standard EN ISO 14971 2019 has already superseded the earlier standard EN ISO 14971:2012, which only harmonized three directives: MDD, AIMDD, and IVDD. EN ISO 14971:2012’s Z annexes contained content discrepancies. The manufacturer had numerous issues in complying with the instructions due to coverage limitations and content divergence. The MDR and IVDR have substantially more thorough and specific criteria for the Risk Management Process than these directives.
The European Committee of Standardization (CEN) published a modification to the version of the Risk Management Standard of Medical Devices, EN ISO 14971 2019, in December 2021. The change is called EN ISO 14971 2019 + Amd11: 2021.
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The Risk Management Standard with its modification (EN ISO 14971 2019 + Amd11:2021) has been released for both EU 2017/745 MDR-Medical Device Regulation and EU 2017/746 IVDR-In Vitro Diagnostic Medical Device Regulations. You must provide references in all paperwork for compliance with regulatory requirements under the Regulation, MDR, or IVDR under the EN ISO 14971 2019 + Amd11:2021 standard.
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Risk Management By New Z Annexes:
First and foremost, there are no content deviations in the New Z Annexes of EN ISO 14971 2019 + Amd11:2021, which is a major relief. The European Amendment including the ‘New Z Annexes’ has now been released and will be harmonized in the first quarter of 2022. The New Z Annexes are ZA and ZB. The ZA and ZB annexes to EN ISO 14971 2019 + Amd11:2021 demonstrate a close link between the standard and the risk management process. According to the New Z Annexes, compliance with the standard implies adherence to the applicable GSPRs of the European Regulations MDR and IVDR.
The three most simplified statements of New Z Annexes are as follows:
- The scope is limited to medical devices and accessories for medical devices as described by the regulations, as well as products classified as devices under the rules.
- In the event of a conflict between terms defined in the European standard and terms defined in the Regulation, the words stated in the Regulation will take precedence.
- The manufacturer’s policy for generating risk acceptability criteria must guarantee that the criteria meet the Regulation’s General Safety and Performance Requirements (GSPR).
GSPRs Protected by New Z Annexes:
Z Annexes contain a table indicating which GSPRs in Annex 1 are covered, i.e. Annex ZA and ZB demonstrate the relationship between the GSPRs in Annex 1 of each legislation and the clauses of the Risk Management Standard for Medical Devices (EN ISO 14971 2019).
GSPRs 3, 4, 5, 8, and 9 are discussed and listed in both Annexes ZA and ZB. They are covered concerning process requirements, but not about the device-specific execution of the Risk Management Process.
GSPR 3 – Regarding the Manufacturer’s Risk Management System
GSPR 4 – Risk Control Measures Adopted by Manufacturer
GSPR 5 – Eliminating or Reducing the Risks
GSPR 8 – All known and foreseeable risks, and undesirable side-effects
GSPR 9 – MDR regarding devices without a medical purpose
Suggestion for Medical Device Manufacturer
EN ISO 14971 2019 + Amd11:2021 lead to give a solution for the Medical Device Manufacturer for implementing a Risk Management System. Medical Device Manufacturers who wish to sell their products in the European Market have to comply with the requirements of the applicable New Z Annexes. Manufacturers should purchase the New Amendment EN ISO 14971 2019 Amd11:2021 understand the requirements of the standard and implement it correctly.
In the Area of Risk Management, both MDR and IVDR have many requirements and the new release of Amd11:2021 provides the foundation for the rest of the requirements like Post-Market Surveillance, Clinical Evaluation, Clinical Investigation, Summary of safety & clinical performance, and many more requirements.
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