Identification and labeling medical device replacement system components

Mark Meer

Trusted Information Resource
#1
Curious how people handle the packaging & labeling of replacement medical device system components.

For example:
An electronic medical device system comes with a power-supply adaptor. The power-supply adaptor is then lost/misplaced by the customer and they request a replacement.

In the context of FDA QSR, ISO 13485 system for devices marketed in US and Europe, how should this be handled?
- Does the replacement component have to have dedicated packaging and instructions?
- Does the replacement component require its own distribution record?
- Does the replacement component require its own catalogue (re-order) number?

...or can we simply take a replacement adaptor from inventory, put it in a FedEx package and have it couriered?
 
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isoalchemist

#3
IMHO their is no single answer, it really depends on what is being seen as a replacement part and its criticality. An AC adapter that is documented in your system should just be a ship. Other components may need to be more controlled. Extend that to who is getting the replacement part as that may change the requirements.
 

Mark Meer

Trusted Information Resource
#4
So, most of these considerations are up to the manufacturer/distributor? That'd be ideal.

...just wanted to check if anyone knows of any applicable regulations (FDA, or EC) that cover these kinds of situations. ...if not, great.
 
L

Lutz Born

#5
I tag along, I hope it’s okay? If not, please shift my Thread (to moderators)
We have a similar issue with our manufacture, only the other way round.
The Situation:
We order a medical device class I (Main body AND power supply) since several years. On both parts in the past there was a CE Label. So far so good, now we ordered only the Main body to replace them on the market, cause of malfunctions.
And now the manufacturer sent us only the Main body WITHOUT the CE label. We requested to deliver these label, but the manufacturer says “they deliver only parts, and they could not be sure that we use these Main bodies with the dedicated power supply, so they don’t deliver these CE labels!”
Now my question: Could the manufacture do so? In my opinion the Main body is a MD itself, only without the dedicated power supply. So the manufacturer has to label them with the CE label. Or am I wrong in that?
Thank you!
 

Mark Meer

Trusted Information Resource
#7
Luz Born:
If the device consists only of the two components you mentioned (Main Body & Power-Supply), in my view the company is skirting regulations by sending you an unlabelled Main Body. I agree with you that the Main body is a MD itself.

...the manufacturer says ?they deliver only parts, and they could not be sure that we use these Main bodies with the dedicated power supply...
This is an example where I'd hoped there'd be some regulations or guidance documents. Do such replacement "parts" have to be identified/labelled somehow? Perhaps with some kind of statement such as "Use only with <parent system>"?

New FDA Draft guidance issued yesterday that clarifies/confuses
You mean the one released some time ago but "issued" yesterday? :lol:

While clarification on "accessory" has been a long time coming for the FDA, there still seems to be room for interpretation regarding "supports the performance of a parent device".
When it comes to replacement parts, I presume the questions to ask would be "would the absence of the part directly affect the intended use performance"? If so, the replacement part would be and accessory, and hence have to be labelled as such. If not, it would not have to be labelled?
 

Ronen E

Problem Solver
Staff member
Moderator
#8
there still seems to be room for interpretation regarding "supports the performance of a parent device".
It is definitely as clear as mud.

Interpretation: The lack of proper FDA definitions regarding accessories to medical devices was a sore point for years. Now there is a document that the FDA can wave and say: "Look, here it is!", while in fact significant vagueness is maintained to allow FDA officers plenty of wiggle room.

When it comes to replacement parts, I presume the questions to ask would be "would the absence of the part directly affect the intended use performance"? If so, the replacement part would be and accessory, and hence have to be labelled as such. If not, it would not have to be labelled?
Replacement parts are generally not accessories, IMO.
For something to be an accessory, it would have to:
a. be placed on the market separately from the device (could be done together, but as two separate codes as in two separate line items, two separate packages etc.); AND
b. the device should be able to fulfill its intended use even without the accessory, albeit in some lesser way.

A replacement part is something that fails both items a & b above during the initial delivery, and at least item b on consequent deliveries.

Cheers,
Ronen.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
I tag along, I hope it’s okay? If not, please shift my Thread (to moderators)
We have a similar issue with our manufacture, only the other way round.
The Situation:
We order a medical device class I (Main body AND power supply) since several years. On both parts in the past there was a CE Label. So far so good, now we ordered only the Main body to replace them on the market, cause of malfunctions.
And now the manufacturer sent us only the Main body WITHOUT the CE label. We requested to deliver these label, but the manufacturer says “they deliver only parts, and they could not be sure that we use these Main bodies with the dedicated power supply, so they don’t deliver these CE labels!”
Now my question: Could the manufacture do so? In my opinion the Main body is a MD itself, only without the dedicated power supply. So the manufacturer has to label them with the CE label. Or am I wrong in that?
Thank you!
Hello and welcome to (posting on) the Cove:bigwave:

The main question should be: "Does the item fall under the (finished) Medical Device definition?"

If that "main body" does so, on its own, then it is a medical device and the regulations apply, regardless of it also being part of another medical device (e.g. body + power supply).

If it doesn't, then it is a component of a medical device (only) and there are far less requirements.

The question of whether or not CE marking is required (and possible) is a little different. A CE mark is a declaration by the manufacturer that the item (and its manufacturer) conforms with ALL the relevant EC directive that include provisions for CE marking. The main body might not be considered a Medical Device on its own (I can't say without full exposure to the details), and thus exempt from the MDD, but still be subject to other directives that provide for CE marking. In that case the manufacturer would have to comply with all those other directives and then apply the CE mark, before placing the item on the EC market.

Cheers,
Ronen.
 
L

Lutz Born

#10
If the device consists only of the two components you mentioned (Main Body & Power-Supply), in my view the company is skirting regulations by sending you an unlabelled Main Body. I agree with you that the Main body is a MD itself.
Thank you! This main body will fulfill its intended use if you use another power supply which meets the voltage/current specifications.

This is an example where I'd hoped there'd be some regulations or guidance documents. Do such replacement "parts" have to be identified/labelled somehow? Perhaps with some kind of statement such as "Use only with <parent system>"?
I’ve read the IFU several times, and such a statement is missing.
I only found this:

The entire electrical system must comply with CEI or IEC standards for electrical systems on medical
premises.“

At section installation, is only mentioned „the transformer box“


But whatever, i.e. we bought the whole system (main body, psu, inclusive all CE) placed it at the customer. Now only the main body gets destroyed/ broken, and we order a new one, with a different serial number and so on, without psu. In my opinion the MF (manufacturer) have to deliver it with CE.
This situation is nothing different as we would only buy the main body, or not?

Hello and welcome to (posting on) the Cove
Thank you! :)

The main question should be: "Does the item fall under the (finished) Medical Device definition?"
This clear definition is missing at the 93/42/EC IMO.
We say, Yes it is. Because you could fulfill its intended use by using an psu which meets the specifications.

They say, NO. It is an unfinished device without the psu.

If that "main body" does so, on its own, then it is a medical device and the regulations apply, regardless of it also being part of another medical device (e.g. body + power supply).

If it doesn't, then it is a component of a medical device (only) and there are far less requirements.
And this is the discussion point we have here.
Is it a MD or not, without the psu.

The question of whether or not CE marking is required (and possible) is a little different. A CE mark is a declaration by the manufacturer that the item (and its manufacturer) conforms with ALL the relevant EC directive that include provisions for CE marking. The main body might not be considered a Medical Device on its own (I can't say without full exposure to the details), and thus exempt from the MDD, but still be subject to other directives that provide for CE marking. In that case the manufacturer would have to comply with all those other directives and then apply the CE mark, before placing the item on the EC market.

Cheers,
Ronen.
We’ve got a DoC (Declaration of Conformity) for this MD.
They have tested the MD according ISO 60601 with their “dedicated” psu.
And they say “if we deliver without psu, we can’t guarantee it is EC conform, so we deliver them without CE”.

The solution in our opinion will be:

They declare a statement in the IFU that the MD is only to be installed and used with their psu (exactly description of psu, article number…).
On the other side, they have to deliver the main body with CE for replacements on the market.

Ronen, Mark, thank you so much so far!
 
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