Seit kurzem ist eine der wichtigsten Normen für Hersteller*innen von Medizinprodukte, der DIN EN ISO 14971:2022-04 „Anwendung des Risikomanagements auf Medical Devices", has become available.
DIN EN ISO 14971 specifies the terminology, principles and a process for the risk management of medical devices, including software as a medical device, and in vitro diagnostics (IVD). The updated version includes European amendment 11 from 2021 and replaces the version from 2020-07.
The following changes were made as part of the update:
- The informative annexes ZA and ZB, which provide the reference to the essential safety and performance requirements, have been added.
- The translations of the terms have been adapted where necessary.
n total there were:
- 725 amendments,
- divided into 264 replacements,
- 137 insertions,
- 66 cancellations.
Especially in connection with the MDR bildet die Neuauflage ein sehr hilfreiches Werkzeug bei der Adressierung der grundlegenden Sicherheits- und Leistungsanforderungen. Auditsicherheit und weit weniger Diskussionsstoff dürften die neuen Anhänge ZA und ZB begünstigen.
All other changes are more wording adjustments. In our view, the most interesting thing here is that the term "intended purpose" has now been replaced by the term "intended use".
Nothing significant should change in your management file with the new version. So don't shy away from the update. The effort involved should be manageable.
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