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In many different ways, the medical device industry is constantly evolving. There are the constant advancement and evolution of technology, which appropriately underlies much of the device industries’ attention.
Similarly, there is the consistent evolution of, and addition to, the global regulatory landscape–established regulators creating new regulatory requirements (e.g., EU MDR/ IVDR), new regulatory imperatives (e.g., track and trace), and new regulators/countries (e.g., China, India) bringing new country-specific requirements.
One of the other major evolutionary aspects of the device industry is more fundamental–the nearly constant set of Merger and Acquisition (M&A) activities. This takes many different forms: entire companies combining together (Medtronic/Covidien; Stryker/K2M), entire portions of companies being spun off–either on their own to other companies (SeaSpine/ Integra; LifeScan/J&J), or as product lines moving from one company to the other (Varian/Boston Scientific’s microspheres business), among other permutations.
These affect companies in many different ways, both profound (e.g., organizational, personnel) and subtle (e.g., quality systems, brand names). Given that M&As are likely to remain a mainstay of the device industry, one of the critical and emerging issues to understand early and adequately address is the effect that these activities have on the device’s identification globally–that is, the device’s (one or more) labeled Unique Device Identifier (UDI) and the associated product data that is housed in the various global regulators’ databases (e.g., US FDA’s GUDID, EU’s Eudamed, SFDA’s SAUDI-D , along with many more coming over the next few years).
To continue reading, "Guidance for Managing UDI in Mergers and Acquisitions," download the complete white paper.
*This white paper was written prior to the European Commision MDR/IVDR deadline delays. Click here for the most recent updates.