Understanding the current expectations of a medical device risk management system is a critical element of meeting the new regulatory requirements.
The incoming European Medical Devices Regulation 2017/745 (MDR) and In-Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) have specified roles for harmonised standards, in demonstrating conformity of medical devices.
Devices conforming with relevant harmonised standards are presumed to be in conformity with the requirements of the regulation covered by those standards. Device conformity also encapsulates system or process requirements, including risk management.
Harmonised European standards include European Annex Zs that show the relationship between the requirements of the standard and the regulatory requirements in the European regulations that are applicable to the scope of that standard.
The content of EN ISO 14971 describes the state of the art for risk management and provides important support in complying with regulations internationally. These documents can be critical in aiding the transition to MDR and IVDR, even without the European Annex Zs. The final draft of EN ISO 14971 included drafts for five European Annex Zs. However, these Annexes were not included in the published text. The intention is to include the agreed versions of these Annexes in a European amendment to the standard.
As companies are revising their technical documentation to the new European requirements, it will be essential to make sure that risk management documentation, including risk management plans and risk management files, meet current expectations.
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