envelope  Contact us

phone1-301-495-0477

Mergers and Acquisitions A Regulatory Point of ViewNews of different mergers and acquisitions have dominated the international medical device landscape for the previous couple years.  As the industry responds to different regulatory and business concerns throughout the world.

 

Planning the Merger or Acquisition

Before the ink is dry on the merger documents, medical device manufacturers should have completed their due diligence on the company with whom they are merging or acquiring. Usually due diligence includes financial and other documents to ensure that the company is actually financially viable, that there is no fraud, etc. However, a new angle of documentation forms when thinking about the operations of merging two different quality management systems, or taking over an entirely new product lines’ regulatory conformity. Manufacturers may want to consider adding QMS examinations and audits into their due diligence planning in order to create their integration plan.

What does the Notified Body need to know?

The notified body needs to be informed first that there is a merger or acquisition that is taking place. Note that the notified body shouldn’t be brought in totally after the fact, but the notified body should be informed as soon as the parties allow in the integration process. This is mostly for continuity of the company’s certification: if there are too many significant changes to the manufacturer’s QMS or product line, the notified body may determine that it needs more time or reviews in order to really assess the manufacturer and their products.

In addition to the ongoing communication, notified bodies should also be informed about:

• Changes to the product line for the products covered by its certificates. For example, does the merger or acquisition add or discontinue a specific product line, affecting the manufacturer’s certificates?

• Changes to the QMS and management structure. Any merger or acquisition would have these changes, which could be substantial changes depending on how they affect the overall QMS and device conformity. What manufacturers shall avoid is the situation where the system that the notified body audits is significantly different from the one they audited the year before without any notification of what changes took place.

• Legal manufacturer name and/or location changes. Changing the name of the legal manufacturer, even if there is no merger or acquisition, changes the party responsible for regulatory conformity, and it changes the company with whom the notified body contracts. Certificates produced under an old name don’t cover the manufacturer under their new name, and so new certificates would need to be created for the new legal manufacturer. Likewise, if a manufacturer changes their headquarters, the new address wouldn’t be covered under the same certificates.

• Changes to the manufacturing process. This happens a lot with mergers or acquisitions of manufacturers in the same device space, where the two manufacturers combine manufacturing processes and facilities. A change to a manufacturing process is a significant change, which the notified body needs to know about. The notified body may perform an additional audit to assess if the new manufacturing process still allows conforming devices to be manufactured.

• Changes to the labelling. Name, location, and product changes also prompt a change in the labeling to reflect new information. Manufacturers should make sure that their labeling is consistent throughout the different documents and changes in order to maintain conformity to the essential requirements surrounding labeling.

While this list may be short, it’s also quite broad because it involves many moving parts. Overall, it is important that manufacturers create an integration plan that covers these points in order to maintain their certification.

LNE DOWNLOAD PDF Download this newsletter in pdf format here.

MDSAP Prepare the transition, worldwide market access

combo ISO 13485 9001

Questions?

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

   1-301-495-0477

lne gmed arrow Submit a request

clientsWe're Hiring!

Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

Training Content: Click here!

Register Today!

 Calendar Notified Body 06 06

Santa Clara, CA