Dear Forum,

Is correct to label sterile a medical device only on the secondary packing?

There are indications on the modality of labelling of the M.D.?

Thank you

Alberto Franceschini
Ferrara

Dear,

Clause 13, Annex I Essential requirements of the MDD is clear on this point. It says in 13.1:
"Each device must be accompanied by the information needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential user.
These information comprises the details on the label and the data in the instructions for use. 13.3 says:
The label must bear the following particulars: (c) where appropriate, the word 'STERILE';"

So it is incorrect to label a sterile medical device only on the secondary packaging because each sterile medical device must be accompanied by a label.
By the way, If you don't do it how can the user be sure an individual medical device is sterile or not?
The same clause 13 tells you everything about the information to be supplied by the manufacturer of a medical device.

Kind regards,
Wim Renders

p.s. for the MDD see question Q00163

Dear Mr. Renders,

I have wrongly cited the secondary packaging labelling but really, in my case, is the dust cover in each pack to be labelled. Is it correct?
Thank you
Alberto Franceschini