Legacy Products - Change in the Legal Manufacturer or EU Representative

C

chudsy

#1
Hi All,
If there is a change in the legal manufacturer or EU representative does the reponsibilty of legacy products remain with the party who was responsible for placing on the market at the time or does the current EU Rep take over any issues which may arise?
I cannot find any documentation to clarify who takes over.
Kind Regards.
 
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pkost

Trusted Information Resource
#2
Re: Legacy Products

In the case of the legal manufacturer, that original entity is always responsible for the products the placed on the market, even if it is 10, 20 years later and they no longer manufacture, even if they transferred the manufacturing rights to another entity.

with regards to EU reps, they are merely a point of contact for the competent authorities, in the event of a change, there should be an agreement in place to identify when the last batch will be manufactured using the old EU rep. the agreement should also identify how the old eu rep should handle any customer complaints/communication they receive (if they receive them). Just discarding them is not acceptable.
 

somashekar

Staff member
Super Moderator
#3
Re: Legacy Products

Hi All,
If there is a change in the legal manufacturer or EU representative does the reponsibilty of legacy products remain with the party who was responsible for placing on the market at the time or does the current EU Rep take over any issues which may arise?
I cannot find any documentation to clarify who takes over.
Kind Regards.
It is about how you contract document with the party (old legal manufacturer) and the EU rep. It is certain that the party or the new party must be competent about the requirement to manage the legacy products.
Please involve a good regulatory consultant in the due diligence when you make plans to acquire CE marked medical device manufacturing.
 

pkost

Trusted Information Resource
#5
Re: Legacy Products

Hi Somashekar,

Perhaps I misunderstand, but it seems to me that you are suggesting that if you put an appropriate contract in place an old manufacturer can hand over responsibility for products they placed on the market to a new manufacturer. This quite simply is not the case, the responsibility will always lie with the entity that placed the device on the market. They may be able to divest themselves of some of the work they have to do with regards to the devices, but not the responsibility.
 

somashekar

Staff member
Super Moderator
#6
Re: Legacy Products

Hi Somashekar,

Perhaps I misunderstand, but it seems to me that you are suggesting that if you put an appropriate contract in place an old manufacturer can hand over responsibility for products they placed on the market to a new manufacturer. This quite simply is not the case, the responsibility will always lie with the entity that placed the device on the market. They may be able to divest themselves of some of the work they have to do with regards to the devices, but not the responsibility.
Hi pkost.
I understand your line of thought.
What if the party intends to dissolve and no more be competent to manage the legacy products. I understand that until the design lifetime of the last product delivered out, either the party (being fully competent) will sustain it OR sell the business along with the load to be sustained as competency changes hands.
 

pkost

Trusted Information Resource
#7
Re: Legacy Products

I don't think the directive really covers this in much detail (in fact not at all) but I think it all depends on the circumstance:

1. If the entitiy exists, it is their responsibility, I don't think they can hand over the responsibility.
2. If the entity is bought out it is the responsibility of the new owner (as they are legally responsible for the old manufacturer)
3. If the entity sells the right to the product, I don't believe they can pass on responsibility for old product, they are just selling the right to manufacture new product.

4. The circumstance that I'm not clear about is if the manufacturer winds up - I believe it falls to the competent authority.


To expand on point 3. - what company in it's right mind would take on the responsibility of a legacy product? The risk would be horrendous. From a marketing point of view you may support old customers just for good will, but there is no good will towards regulations/government. If you take on the responsibility you are taking on risk for no gain, there is no business sense in this.


...this is turning into an interesting discussion!
 
C

chudsy

#8
Re: Legacy Products

From what I can understand, if both parties are still in existence it would be the person who held the DOC at the time.
As pkhost states, it wouldn't be very good business sense to inherit the responsibility of a device who's history you may know very little about.
You're right also pkhost - there's nothing written in the MDD regarding the responsibilities as far as I can see.
Regards
 

somashekar

Staff member
Super Moderator
#9
Re: Legacy Products

To expand on point 3. - what company in it's right mind would take on the responsibility of a legacy product? The risk would be horrendous. From a marketing point of view you may support old customers just for good will, but there is no good will towards regulations/government. If you take on the responsibility you are taking on risk for no gain, there is no business sense in this.
The business sense comes from the regulatory due diligence on the extent of products that needs to be sustained, from the study of any past regulatory complications faced, recalls made, open issues pending from the party to competent authorities, etc etc..., and arriving at a base price for the deal coupled with assessment of future market potential and the vision of the new party.
 

pkost

Trusted Information Resource
#10
Re: Legacy Products

If the product is already on the market the key data that you require with regards to vigilance should be public in the form of FSN's. There is no point in buying publicly available information.

If you are "buying" the rights to manufacture a previously CE marked device, you should include in the purchase agreement a clause requiring all necessary information to gain regulatory approval. This would cover any "open" issues that are not public. It does not require the the new manufacturer taking on the risk of the legacy product.
 
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