Combination Products - Distributor of the device?

#1
Hello,

My company is marketing authorization holder of combination products, both single-entity and co-packaged. We are wondering, if under MDR we become distributor of the device part supplied as part of the combination product or if simply Article 117 applies to us.

So far we have 2 opinions, 1 from a consultant saying we are not distributor.

Has anyone here experience with this?

Thank you for any input!
 
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chris1price

Trusted Information Resource
#2
Welcome to the joys of Article 117 :eek:

Regarding the single-entity combination product, Article 117 modifies the text of the pharma directive 2001/83/EC to say you need an opinion of conformity with Annex 1 of the MDR from a notified body. There is no requirement to comply with the other parts of the MDR, such as the articles for distributors. So the consultant is correct.

However, for the co-packaged product, if the device part is CE Marked as a medical device, it has to comply with all the MDR, potentially including the distributor requirements.
 
#3
Thank you chris1price!

For single-entity with a device with no CE mark this is also my understanding.

However, would you also say only Article 117 applies even if the device part of the single-entity combination is CE marked and therefore again the whole MDR must be complied with by the supplier?

For co-packaged we will get another opinion from another consultant but so far, suppliers are pushing us to sign new QAAs stating that we are the distributor.

I believe no one is really 100% sure how to handle combination products in the EU properly :eek:
 

chris1price

Trusted Information Resource
#4
You are correct, if the device part of a single-entity combination product is CE Marked, then you must comply with the whole MDR for that device.

If another company is CE Marking the device in the co-packed product, you are likely to be the distributor.
 

L_O_B

Involved In Discussions
#6
Hi ComboConfused

The information you provided may be a little thin.
In Europe the term "combination product" is not defined. We have integral drug device combinations as described in 2017/745 article 1(8) and 1(9). A medical device co-packaged with a medicinal product is no such combination. I asked the EMA about this and got the following answer:

"If the empty syringe is co-packaged with the vial it is not considered an integral Drug-Device Combinations, even if it has been specifically designed for a single medicinal product."

Therefore, the medical device and the medicinal product must comply with applicable legislation. They are not a combination product, but two separate products packaged together. They could be treated as a procedure pack as defined in 2017/745, but this does not relieve you from complying with respective legislation. Thus, in a case where you have a co-packaged products that do not fulfil the scenario described in article 1(9) and you are not the manufacturer of the device, I would expect you to comply with the requirements for distributors.
 
#7
Hi L_O_B

let me specify: we have both integral drug device combinations and non integral drug device combinations as defined by EMA in a guideline from 2019: draft-guideline-quality-requirements-drug-device-combinations_en (I am not yet allowed to post links unfortunately)

for integral drug device combinations we are likely not distributor of the device, but for the non-integral it is nowhere specifically defined.

For sure, each part of the non-integral DDC must comply with its respective regulations, but in the end we are MAH of a non-integral drug device combination product, but are we also distributor of the device component? It could be.

We anyhow comply with most requirements already, but some would mean a lot of additional workload, therefore I really want to make sure we are legally seen as a distributor.
 

L_O_B

Involved In Discussions
#8
Hi ComboConfused,

I may have a biased view here, since I am mostly involved in the medical device industry and I only get in touch with medicinal products, whenever a medical device gets combined with a medicinal product.

I agree that you are not a distributor by the meaning of the MDR for the integral DDC. The device does not have a market access on its own and therefore there cannot be a distributor.

In case of the non-integral DDC, the dossier for the marketing authorization does not claim that the device itself is suitable for the market, but that the two products are safe to be used in combination. From the perspective of the regulation you still just buy a medical device and sell it on without alteration.
For me this sounds like you should comply with the distributor requirements. What makes you doubt that?
 
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