Distributor Requirements for Sterile Disposable Medical Devices

#1
We manufacture a non-sterile Class II device. We have a customer who is requesting that we provide a sterile handle cover (manufactured by a 3rd party) with the device for use in sterile environments. Currently, we make no claims on our device sterility whatsoever. This would remain the case even if we agreed to provide the sterile handle covers. If we agree to this arrangement, what additional FDA or EU requirements do we assume, if any?

In the best case, I see us as a distributor for a 3rd party manufacturer of sterile handle covers with no additional responsibilities whatsoever. In the worst case I see us getting involved with sterility "issues" at a level we are not prepared to pursue.

In reviewing FDA regulations, unless you are the "Initial Distributor" of an imported device, no registration appears to be required for distributors of domestically produced devices. Whether the device is sterile or not does not appear to impact this requirement. But again, I'm looking for feedback from "The Cove" as this is not my area of expertise.
 

MIREGMGR

Inactive Registered Visitor
#2
In the best case, I see us as a distributor for a 3rd party manufacturer of sterile handle covers with no additional responsibilities whatsoever.
In FDA's jurisdiction, yep, that's it. Or you could be a re-labeler, with the same responsibility stance.

Of course, if the 3rd party manufacturer's product is custom developed for your product, you need to make sure that the 3rd party manufacturer has the same understanding of regulatory responsibility as you. It would be prudent to have that understanding be part of a purchase order or other contractural relationship.

In the EU, generally the same situation should hold true.
 

Rolande Hall

Inactive Registered Visitor
#3
:(
Hi Guys,
Unfortunately I think that placing a “sterile handle cover” on the market in the EU is not as simple as the last comments would indicate. As the item is to be sold sterile, the manufacturer must lodge an application for assessment of his quality system with a notified body.

Note that the EU directive 93/42/EEC, states that:For the purposes of this Directive, accessories shall be treated as medical devices in their own right.’
Labelling of the main device and the sterile handle cover should link the two items that are be used together.

(f) [FONT=TimesNewRoman+20]‘manufacturer[FONT=TimesNewRoman+20]’ [/FONT]means the natural or legal person with responsibility [/FONT]for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name.

(j) [FONT=TimesNewRoman+20]‘authorised representative[FONT=TimesNewRoman+20]’ [/FONT]means any natural or legal person established [/FONT]in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;
(h) [FONT=TimesNewRoman+20]‘placing on the market[FONT=TimesNewRoman+20]’ [/FONT]means the first making available in return [/FONT]for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;
13. Information supplied by the manufacturer [FONT=TimesNewRomanBold+25]▼M5[/FONT]
13.1. Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.
13.6. Where appropriate, the instructions for use must contain the following particulars:

(c) if the device must be installed with or connected to other medical devices or equipment in order to operate as required for its intended purpose, sufficient details of its characteristics to identify the correct devices or equipment to use in order to obtain a safe combination;
(i) details of any further treatment or handling needed before the device can be used (for example, sterilization, final assembly, etc.);

I hope these notes clarify the position rather than confuse.
EN 1041 gives further guidance on the labelling and IFU requirements of 93/42/EEC.

Good luck Watchwait with your project.
 

MIREGMGR

Inactive Registered Visitor
#4
Unfortunately I think that placing a “sterile handle cover” on the market in the EU is not as simple as the last comments would indicate. As the item is to be sold sterile, the manufacturer must lodge an application for assessment of his quality system with a notified body.

Note that the EU directive 93/42/EEC, states that:For the purposes of this Directive, accessories shall be treated as medical devices in their own right.’


Yes, absolutely. Certainly it would be essential for Watchwalt's company to choose a cover-and-drape maker offering both FDA compliance and 13485/MDD compliance, whether the required cover is an existing product or a custom solution. That's not uncommon...my employer offers that, for instance.

Assuming that's done, Watchwalt's company's desire to be a distributor for a second company that makes the sterile disposable cover and handles regulatory compliance is a perfect fit with MDD's statement that accessories are independent medical devices.

Labelling of the main device and the sterile handle cover should link the two items that are be used together.
Certainly the user directions for Watchwalt's company's device should indicate that if that device is to be used in a sterile context, a specified sterile cover should be appropriately used. There is no 13485/MDD requirement, though, that the sterile cover be labeled in a manner that links it only to Watchwalt's company's device...unless "the device must be installed with or connected to other medical devices or equipment in order to operate as required for its intended purpose", i.e. it is designed specifically and solely for Watchwalt's company's device. If on the other hand that cover is one of its maker-company's standard products, with multiple applications, no such requirement applies.
 
#5
Gentlemen,

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.

2-In the EU....I think there are a few more potential questions/issues to be clarified:

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.

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.

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.

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...
 

Rolande Hall

Inactive Registered Visitor
#6
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.:agree1: I agree

2-In the EU....I think there are a few more potential questions/issues to be clarified: :agree1: 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.
:caution: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...
"Placing on the market" is defined in subparagraph (h) of Article 1 of the directive 93/42/ECC. as follows:-
h) [FONT=TimesNewRoman+20]‘placing on the market[FONT=TimesNewRoman+20]’ [/FONT]means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;[/FONT]

"Putting into service" is defined in subparagraph (i) of Article 1 of the directive 93/42/ECC. as follows:-
(i) [FONT=TimesNewRoman+20]‘putting into service[FONT=TimesNewRoman+20]’ [/FONT]means the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose;[/FONT]

Note the timing distinction between the term “the first making available” and has been made available to the final user”. Clearly (h) comes before (i).
The manufacturer places the product on the market.
The medical team puts it into service.

Happy New Year to you and all our readers.
 

MIREGMGR

Inactive Registered Visitor
#7
A further bit of clarification.

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.
:caution: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.
(Emphasis in black bold applied above.)

As you note--in order to provide you with the EU regulatory stance you desire, the company that manufactures the handle cover either must be located in the EU or must have their own Authorized Representative. In either case, this status will be indicated on their label on their product.

As such, your Authorized Representative would not list that product, because they list only the products for which you are the Manufacturer.

(A possible exception to this: if you distribute another company's products in the EU, but your distribution is by means of inclusion in a procedural-disposables kit that you create, you then take on a share of the manufacturer role. We have a number of kit products of this type, marketed with our CE mark and regulatory identifying number and containing another company's manufactured medical device that is provided to us in bulk sterile form...even though that device already carries its manufacturer's CE mark and regulatory identifying number.)

Because the product in question is a sterile medical device, the CE mark on its label will have appended to it the appropriate identifying number. I assume that the robotic medical device on which the handle cover is to be used, also is of an MDD device class above I and therefore also will carry a CE mark with appended identifying number. In the latter case, the identifying number will pertain to your company's regulatory arrangements. In the former case, the identifying number will pertain to the handle cover manufacturer's regulatory arrangements.
 
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#8
All this makes great sense and seems consistent with the prevailing regs. Nevertheless, I have queries out to both our Notified Body & our Authorised Representative to ensure they are in agreement with this understanding. When in doubt, they are always my final source.

On the domestic side, I spoke with DSMICA yesterday who provided me with some bad information. They tried to convince me that our company would be acting as an "Initial Distributor" for the aforementioned products. I tried to tell them that these were NOT imported products, and we did not fit the CFR 21 definition of an Initial Distributor. At this point, she became agitated with me and insisted that what I just described was an Initial Importer. Unfortunately, the term Initial Importer is absent in CFR 21 Part 807. At this point, I threw in the towel. My tax $$$ at work...:frust:
 

MIREGMGR

Inactive Registered Visitor
#9
I think the DSMICA telephone-duty person is sometimes pretty junior. They can be useful at times, but as you know a reality check is always in order.
 

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