Gentlemen,
New comments by RH are in Blue
Thanks much for the thorough review of my case! Since I've not yet mastered the "Quoting" feature my response may not be as "tight" as I'd prefer (advance apologies!).
OK - based on your collective feedback, I've formulated the following "opinions":
1-Regarding US distribution, I think we're probably in good shape here. FDA has a very clear definition of a distributor & we fit that definition to a "T". We are purchasing a sterile Class II medical device from a domestic FDA registered facility. We will not re-label or repackage the device. We will not add our name anywhere on the product or packaging. So unless I've missed something, this seems a pretty clean distribution path domestically.
I agree
2-In the EU....I think there are a few more potential questions/issues to be clarified:
I agree
a) We definitely do not fit the definition of a manufacturer per 93/42/EEC. We perform none of the duties listed in the definition & we do not have the intent to place products on the market "under his own name". Unfortunately, I do not see an EU counterpart to the FDA classification of a "Distributor". Does any such designation exist within the confines of 93/42/EEC? If so I've yet to find them.
"Distributor" is not defined in 93/42/EEC, in the absence of a definition in the English language version of a directive it is customary to use the 'Oxford English Dictionary' as a reference.
b) Further, since we are not the "manufacturer", the requirements for "Information to be supplied by the manufacturer" do not apply to us (the distributor). However, the manufacturer in his own labeling (supplied with the product) provides all the appropriate information for the generic use of this handle cover (regardless of whether that handle is affixed to a light, a reflector, a mirror, etc.) We think this generic application is key.
I agree, however, any product that you distribute must comply with 93/42/EEC, guidance standard EN 1941 applies to information that must accompany the product. In particular contact details for the manufacturers Authorised Representative must appear on the label.
c) We have an Authorised Representative in place in the EU. Currently, the list of distributed products does NOT include the sterile handle cover. It only lists those products which we manufacture & distribute within the EU. Adding the sterile handle cover to this list would seem inappropriate as we have had no involvement in the design or manufacture of this device. For that matter, the manufacturer of the sterile handle very likely distributes product in the EU under their own name, and as such would either have a presence in the EU or their own Authorised Representative. In either case, that would seem to eliminate our need to revise our list of distributed products in the EU to add this sterile handle cover. Or - maybe not. This one really is unclear to me.
Your Authorised Representative must list all your products that are placed on the market in the EU.
Your Distributor will need to maintain traceability records for all products that he sells.
d) Finally, can someone give me a quick plain language example of the difference between "Placing on the market" and "putting into service"? I've read the definitions in 93/42/EEC numerous times and I'm still confused. Having any type of example would also help! Again, I need this understanding as this too may have an impact on our situation...