Medical Devices - Information to be Supplied by the Manufacturer
This international document specifies requirements for the information that should be provided by medical device manufacturers (including accessories). DIN EN ISO 20417:2021 contains the generally applicable requirements for the marking and labelling of a medical device or accessory, the packaging, the labelling of a medical device or accessory and the accompanying information. This document does not specify how the information must be provided.
The following aspects are specified in DIN EN ISO 20417:2021 :
- Requirements for the information elements such as addresses, designations, codes and numbers etc.
- Requirements for accompanying information and its legibility, durability, etc.
- Information to be created specifically for accessories
In addition to the requirements, the DIN EN ISO 20417:2021 standard also contains examples for verifying the measures. You are therefore shown how you can test the durability of your labelling yourself in order to prove compliance with the standard.
European manufacturers should note that the EN version has not yet been published. This is still at the draft stage. However, this standard should be taken into account for regulatory tasks outside the EU member states. Furthermore, specific requirements of medical device product standards or group standards take precedence over the requirements of this document.
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