Previous person made the best comment: there are alot of things to consider. When acquisitions, divestitures, or merging of commpanies is made, it is very important to consider who will be the legal manufacturer and when. If the device is Class I M,S or IIa and above this requires Notified Body intervention. If the NB at the selling company and NB at the acquiring company are different, this complicates the matters even more. You are right to have some transition period between the two companies, but more importantly it may not be 3 months or 6 months. Strongly recommend creating a quality plan that manages this activity and then contacting each of the NB to make them aware. Because to be honest it is not about your timing - it is about the timing of the NB when they can perform the QMS audit and Tech Doc file review for the acquisition company to become the new legal manufacturer. Of course, if this is a Class I NM, NS device, then 6 months sounds reasonable to get all of the technical documentation "switched over" to the new company. The point of when the acquiring company becomes the legal manufacturer can be at your discretion and should commence once the hand-over is made and the new Declaration of Conformity is approved.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 28-Nov-2018 11:55
From: Anonymous Member
Subject: Timing of CE Marked Device after Acquisition
This message was posted by a user wishing to remain anonymous
The company acquiring the device will become the legal manufacturer and therefore cannot place its own CE mark on the device until its quality system and technical documentation demonstrate compliance with the relevant regulatory requirements. If the device is class IIa or greater, there will be NB involvement and possibly even a NB audit depending on the new NB's policies and how different the device is from the acquiring company's other CE marked devices.
I went through a similar process a few years ago and there is a lot to consider when the acquiring company becomes responsible for all legacy design/testing/mfg etc for the device. There were a number of issues that the old NB was apparently ok with that the new NB was not.
Original Message:
Sent: 27-Nov-2018 06:56
From: Gary Turner
Subject: Timing of CE Marked Device after Acquisition
I am working with a client who is acquiring a CE marked device from another company. For a short time (maybe 6 months) after acquisition the selling company will continue to manufacture the device for the acquiring company, until there is sufficient inventory to allow the manufacturing to be moved to the acquiring company.
When should the CE mark be changed to the acquiring company's mark? Immediately upon acquisition while the selling company is manufacturing, or when the device manufacturing is transferred?
Does anyone have experience with this? Thanks for your help!
Gary Turner
Sent from my Verizon, Samsung Galaxy smartphone