ISO 20417 crucial changes

[lennsy]

Hello everyone,

Since there is a ISO 20417 standard available, I would like to ask you for help in general consideration of crucial changes for our products in terms of possibility to declare compliance with this standard. Its form has changed a bit when it comes to particular sections, the topic of understanding label vs accompanying information has been solved as well as some topic not directly explained in MDR. Is anyone could help with general overview of crucial changes which should be implemented in pratice for medical devices, their labelling which let us to declare compliance with new standard instead of EN 1041?

Thank you in advance for all your help and guidances.

 

[EmiliaBedelia]

Which aspects are you confused by? It is a straightforward standard. The best way to do this is to buy the standard, look at the requirements against your labeling, and figure out whether there is a gap.

The labeling requirements in MDR itself have more "crucial changes" than ISO 20417. You should reference them both.