In the medical device industry, risk management goes beyond product development and manufacturing; it forms a vital aspect of the lifecycle of your product. ISO 14971:2019 defines the international requirements of risk management systems for medical devices, defining best practices throughout the entire lifecycle of a device.
To ensure your organization brings a compliant product to market efficiently and safely, you need to successfully implement a risk management system.
The Medical Devices Regulation (MDR) (EU) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 include the requirements for risk management.
Compliance to risk management standards is not mandatory for CE marking medical devices under the European Medical Device Regulations (IVDR and MDR). Although it isn’t currently harmonized to the Regulations, EN ISO 14971:2019 represents the state-of-the-art for risk management.
EN ISO 14971:2012 is harmonized to the European Medical Device Directives (AIMDD, IVDD and MDD), which allows presumption of conformity to the Directives.
Manufacturers certified under the Directives may choose to comply with the harmonized 2012 version or the state-of-the-art 2019 version of the standard. Manufacturers certified under the Regulations choosing to utilize ISO 14971 should comply with the state-of-the-art 2019 version of the standard.
ISO 14971:2019 provides internationally recognized methods to reduce risk for all stakeholders. Adopting this standard early in the planning process will support you in ensuring that your medical device is compliant with EU Regulations and in bringing your medical device to the global market efficiently and safely.
