EN ISO 14971 2019
Two years’ back EN ISO 14971 2019 Medical Devices – Application of Risk Management to medical devices was published. Harmonized Standard EN ISO 14971 2019 has already replaced the previous standard EN ISO 14971:2012 which was only harmonized for three directives MDD, AIMDD and IVDD. There were content deviations in the Z annexes of EN ISO 14971:2012. The limitation of the coverage & the content deviation caused many problems for the manufacturer in compliance with the directives. The MDR and IVDR have significantly more comprehensive and detailed requirements for the Risk Management Process as compared to these directives.
On December, 2021 European committee of Standardization CEN has released an amendment to the edition of Risk Management Standard of Medical Devices, EN ISO 14971 2019. The amendment is entitled EN ISO 14971 2019 + Amd11: 2021. Edition of Risk Management Standard with its amendment (EN ISO 14971 2019 + Amd11:2021) published for both EU 2017/745 MDR- Medical Device Regulation & EU 2017/746 IVDR – In Vitro Diagnostic Medical Device Regulation. You will be required EN ISO 14971 2019 + Amd11:2021 standard to give the references in all the documentation for compliance with regulatory requirements under the Regulation, MDR or IVDR.
New Z Annexes:
First of all, there are no any content deviations in the New Z Annexes of EN ISO 14971 2019 + Amd11:2021; which is a big relief. The European Amendment containing ‘New Z Annexes’ has been finally released and will be Harmonized in the First Quarter of Year 2022. The New Z Annexes are ZA and ZB. ZA and ZB annexes in EN ISO 14971 2019 + Amd11:2021 show a strong bond between the standard and the Risk management process. New Z Annexes state that the compliance with the standard gives the presumption of the conformance with the applicable GSPRs of the European Regulations MDR and IVDR.
The three most Simplifying statements of New Z Annexes are as follows,
- 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.
- In case of differences between terms defined in the European standard and terms defined in the Regulation, the terms defined in the Regulation shall take a priority.
- The manufacturer’s policy for establishing criteria for risk acceptability shall ensure that the criteria comply with the General Safety and Performance Requirements (GSPR) of the Regulation.
GSPRs Covered by New Z Annexes:
Z Annexes contain a Table showing which GSPRs in Annex 1 are covered i.e. Annex ZA and ZB show the relationship between the GSPRs in Annex 1 of each regulation with the clauses of Risk Management standard of Medical Devices (EN ISO 14971 2019).
GSPRs 3, 4, 5, 8 & 9 are covered and listed in both Annexes ZA and ZB. They are covered with respect to process requirements but not in relation to 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 Risk Management System. Medical Device Manufacturers who wish to sell their products into the European Market have to comply with the requirements of the applicable New Z Annexes. Manufacturers should have to purchase the New Amendment EN ISO 14971 2019 Amd11:2021 and 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 provide the foundation to the rest of the requirements like Post-Market Surveillance, Clinical Evaluation, Clinical Investigation, Summary of safety & clinical performance and many more requirements.
The team of Operon Strategist assist medical device manufacturer in medical device licensing, regulation and to understand changed amendments .For any queries related with regulations and turnkey projects contact us, our representative will surely assist you.
