Acquired Medical Devices - Company A buys the entire rights

[JoCam]

Hi All,

If Company A buys the entire rights (design, trade name, technical file, manufacturing etc.) of a class I medical device from Company B, does Company A need to re-label any historical stock of the product they acquire during the purchase with their name and address before being able to sell it?

Obviously Company A will need to ensure that any of the product they manufacture from their manufacturing facility going forwards will need to carry their address, and that a new Technical File, essential requirements checklist, Declaration of Conformity etc. will need to be compiled. However, in the meantime, what happens to the existing stock? Can it still carry Company B's name and address?

Jo

 

[chris1price]

When I went through a similar experience, we made sure that customers could use the contact details on the old stock, (eg email, web address, phone numbers and physical address) and that the contact details all forwarded to the new company. We also repeatedly verified that the links were still working.

 

[QAengineer13]

When I went through a similar experience, we made sure that customers could use the contact details on the old stock, (eg email, web address, phone numbers and physical address) and that the contact details all forwarded to the new company. We also repeatedly verified that the links were still working.

Thanks Chris for sharing your experience with us, I have another hypothetical situation where in say after you acquired the company with no doing lot of due diligence and then later it came to limelight that the previous design control documents had gaps say for instance in V&V and stuff, in that situation what would be a good approach to handle this case?

 

[pkost]

It depends on what part of the V&V activities had been missed, is there any benefit in plugging the gap from a risk and safety perspective.

For example, if you didn't verify that the final design complied with customer requirements, then I would say risk is small. Write a short justification to say that the customer is now happily buying the product!

If however you forgot to validate the sterile barrier, then you urgently need to fix that and do the studies necessary to demonstrate that the product is sterile

 

[somashekar]

Hi All,

If Company A buys the entire rights (design, trade name, technical file, manufacturing etc.) of a class I medical device from Company B, does Company A need to re-label any historical stock of the product they acquire during the purchase with their name and address before being able to sell it?

Obviously Company A will need to ensure that any of the product they manufacture from their manufacturing facility going forwards will need to carry their address, and that a new Technical File, essential requirements checklist, Declaration of Conformity etc. will need to be compiled. However, in the meantime, what happens to the existing stock? Can it still carry Company B's name and address?

Jo

During the complete process of buyout, a future (reasonable) date can be set for the regulatory, and communicated to the market. Company A and B together can agree upon how the regulatory transfer will be managed and completed.