PD CEN ISO/TR 24971:2020 Medical devices — Application of risk management to medical devices is a key horizontal standard for the medical device market, guiding manufacturers in the development, implementation and maintenance of a risk management process for medical devices.
This document – PD CEN ISO/TR 24971:2020 – is a Published Document and the UK implementation of an international Technical Report that gives guidance on conforming to BS EN ISO 14971:2019.
Who is PD CEN ISO/TR 24971:2020 for?
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Medical device manufacturers
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Regulators
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Other users of BS EN ISO 14971
Why should you use PD CEN ISO/TR 24971:2020?
It gives guidance to help manufacturers develop, implement and maintain a risk 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.
The clauses and sub-clauses in PD CEN ISO/TR 24971:2020 have the same structure and numbering as the clauses and sub-clauses of BS EN ISO 14971:2019.
Further division into sub-clauses is applied where considered useful. The informative annexes contain additional guidance on specific aspects of risk management.
NOTE 1: Alternative approaches to those supplied in PD CEN ISO/TR 24971:2020 may be used if these satisfy the requirements of BS EN ISO 14971:2019.
NOTE 2: When judging the applicability of the guidance in this document, users should consider the nature of the medical device(s) to which it will apply, how these medical devices are used, and the applicable regulatory requirements.
How has PD CEN ISO/TR 24971:2020 changed since the last update?
This is a complete technical revision.
- Clauses in ISO/TR 24971:2013 and some informative annexes from BS EN ISO 14971:2007 have been merged, restructured, technically revised and supplemented with additional guidance
- To make the document easier to use, it has the same structure and numbering of clauses and sub-clauses as BS EN ISO 14971:2019
- The informative annexes contain additional guidance on specific aspects of risk management.