Improving the safety of medical devices

03.08.2020
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Reducing and managing risks related to medical devices is the objective of a key industry standard, EN ISO 14971. Detailed guidance to optimize its use has just been updated.

CEN ISO/TR 24971Medical devices – Guidance on the application of EN ISO 14971, is a companion document to the globally recognized risk management standard EN ISO 14971Medical devices – Application of risk management to medical devices. This standard, which was updated in December 2019, specifies the terminology, principles and process for managing the risks associated with medical devices, including software as a medical device (SaMD) and in vitro diagnostic (IVD) medical products.

Providing detailed guidance on how to use the standard most effectively, the recently published technical report – CEN ISO/TR 24971 – clarifies the requirements of the standard and contains recommendations and practical examples on how to achieve compliance with those requirements. It follows the same structure and the same clause numbering as EN ISO 14971 to facilitate its use.

Intended for use by manufacturers of medical devices, both EN ISO 14971 and CEN ISO/TR 24971 are designed to be read and applied together, providing information on how to identify the hazards associated with medical devices, and measure and manage related risks.

Both documents were developed jointly by technical committees ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/TC 62, Electrical equipment in medical practice, of the International Electrotechnical Commission (IEC), with the active involvement of many regulators from around the world. They can be purchased through our webstore.