What is PD CEN ISO/TR 24971 - Medical devices about?
PD CEN ISO/TR 24971 discusses guidance on the application of ISO 14971 for medical devices. PD CEN ISO/TR 24971 guides the development, implementation, and maintenance of a management system for medical devices according to ISO 14971:2019.
The management process can be part of a quality management system. Some requirements in ISO 13485:2016 are related to risk management and can be fulfilled by applying ISO 14971:2019.
These medical devices include active, non-active, implantable, and non-implantable medical devices, software as medical devices, and in vitro diagnostic medical devices.
Who is PD CEN ISO/TR 24971- Medical devices for?
PD CEN ISO/TR 24971 on guidance on the application of ISO 14971 for medical devices is useful for:
- Medical device manufacturers
- Test centres for medical devices
- Regulatory authorities
Why should you use PD CEN ISO/TR 24971 - Medical devices?
Development, implementation, and maintenance of a management process for medical devices that aims to meet the requirements of ISO 14971:2019, Medical devices- Application of management to medical devices. It guides the application of ISO 14971:2019 for a wide variety of medical devices
PD CEN ISO/TR 24971 guideline helps you to develop, implement and maintain a management process for all medical devices that aim to meet the requirements of BS EN ISO 14971. It covers a wide variety of medical devices including active, non-active, implantable, and non-implantable medical devices, software as medical devices, and in vitro diagnostic medical devices. This helps in minimising and improving the workflow of operations.
What’s changed since the last update?
PD CEN ISO/TR 24971:2020 supersedes PD CEN ISO/TR 24971:2013, which has been withdrawn. PD CEN ISO/TR 24971:2020 has some technical changes with respect to PD CEN ISO/TR 24971:2013. These include:
- The clauses of ISO/TR 24971:2013 and some informative annexes of ISO 14971:2007 are merged, restructured, technically revised, and supplemented with additional guidance
- To facilitate the use of this document, the same structure and numbering of clauses and subclauses as in ISO 14971:2019 is employed. The informative annexes contain additional guidance on specific aspects of risk management.