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). This document contains the generally applicable requirements for the marking and labeling of a medical device or accessory, the packaging, the labeling of a medical device or accessory, and the accompanying information. This document does not specify the manner in which 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 concerning the accessories
In addition to the requirements, the standard DIN EN ISO 20417:2021 also contains examples for verifying the measures. It is shown how you can test the durability of your labeling yourself in order to prove conformity with the standard.
European manufacturers should note that the EN version has not yet been published. It 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.