Transactions under MDR

#1
i all,

I've recently discovered this forum and I think it will be really helpful! I'm starting in regulatory affairs and I have a lot of doubts related with the MDR!!!

This doubt is related with transactions MDR requirements during, for instance, a due dilligence process. I've already posted this post elsewhere in the forum but I do not know if it was the best place to post it.

I do not know if the MDR explicitly describes the requiremens/restrictions for transactions and what the affected companies should consider in this situation. Fom what I know, nothing is stated in the MDR...

Therefore, when a company plans to acquire another one, which main regulatory/legal requirements should be taken into consideration?
For example, is there a way of transferring the NB certificates from the company to the buyer company? Or certificates can not be tranfered and the buyer company should obtain new CE marks certificates?

Another question would be, if a company is planning to acquire now a MD company, could the MDs currently on the market and benefiting of the legacy period until 2024 be transferred to the new company? Which would be the requirements or scenario for a MD to be acquired by a different company and still being able to benefit from the transition period until 2024?

Maybe I can summarise all the avobe in: under which condictions the CE mark can be transferred to the buyer/another company and which transition periods apply to this devices? are there any other requirements that we should consider?

Many thanks in advance for your time!

Best
A.
 
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Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#2
A change in ownership (Management) would be considered a significant change from my experience to your QMS. It's best to contact your NB and ask them. This is a public document from a NB for example.

Quality Management System (QMS) Change:

New Ownership
New Company Name
Change to scope of Existing Registration
Change in Management Representative
Changes to Quality Manual
Change of EU Representative
Change in Critical Supplier
Relocation of Design or Production activities
Addition or reduction in Facilities

Move to a New Location
Expansion of existing Facility
Elimination of existing Facility
New Location (Please submit GAD-25-01
 
#3
Dear Arin,

The change of ownership itself would not be an issue, as otherwise stock corporations would have a challenge. But as a result of the acquisition there might be subsequent changes which are listed in Ed's comment.

A CE mark under MDD cannot be transferred. Basically a new certificate or even a declaration of conformity cannot be issued anymore. Therefore you have to keep the current setup. As substantial changes are also not possible, you have very limited flexibility.

The only way is to keep the legal entity of the legal manufacturer as well as the elements as mentioned above consistent. Only non-substantial changes are possible.

Best regards,
Torsten
 
#4
Hi again,

First of all, thank you both for your responses.

Then, if I understand correctly, a change in ownership would trigger a significant change and the need for the NB to intervene, which would revoke the legacy status until 2024 of a certificate issued under the MDD.

So, what do you suggest in terms of companies planning to acquire a MD-company? You mention that the only way would be to keep the legal entity of the legal manufacturer. Would that be possible in a Merge&Acquisition process?

Many thanks in advance for your responses and your help!

Best regards,
 
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