MDD 93/42 EEC - Requirements for Detachable Medical Device Components

A

Annro

#1
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.
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
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.
The text says:
Wherever reasonable and practicable, the devices and detachable
components must be identified, where appropriate in terms of
batches, to allow all appropriate action to detect any potential risk
posed by the devices and detachable components
I understand that to say that batch identification is a good idea whenever it can be helpful in allowing the scope of field involvement of a particular discovered problem to be narrowly defined so that corrective action can be taken more quickly and effectively.

It does say "must", but it also provides a judgement-qualifier.

I have been told that detachable components include labels applied to packaging
I've never heard that interpretation.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
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.
 
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