A
My company (manufacturer and distributor of ophthalmic devices) wants to distribute a medical device (vitrectomy cutter) that we purchase from the true manufacturer. The device is CE marked, and the package label and IFU appear to meet labeling requirements in Article 13 of MDD 93/42/EEC. I believe that Article 12 may apply in this situation, but that is for another discussion. My question is: can't I simply place the device, leaving the manufacturer's packaging and labeling intact, inside a clear poly bag and place my company's package label on the poly bag identifying us as the distributor (along with our part number and description of the device)? I have spent way too many hours reading the MDD, ISO 13485, 21CFR820, and numerous guidance documents and internet resources and have yet to find something in plain English advising me how to label medical device secondary packaging for distribution, regardless of destination. Thank you in advance.
Happy Holidays,
David
Happy Holidays,
David