Hi could someone help me clarify 13.5 annex 1 of the MDD. I understand devices and detachable compenents must have a batch for identification. I have been told that detachable components include labels applied to packaging.
Please also note that 13.5 requires identification but not necessarily in terms of batch ID - this is required only "when appropriate". One common interpretation of "when appropriate" says that something
is appropriate when refraining from it might significantly affect safety and effectiveness.
Regardless of regulation, I think it makes a lot of sense to identify all labeling by means of including their part ID and revision ID (could be a release date) in the artwork. Generally, I'm not sure how stating a batch ID on labeling would
significantly increase safety and effectiveness beyond those provided by part ID and revision ID, but that probably needs to be considered in your specific circumstances.
Cheers,
Ronen.