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Borderline medical products: a crisis of identity or an opportunity to build the brand?


Global Regulatory Services (GRS) is delighted to announce that an article written by Greer Deal, Director, has been published in the July/August edition of the Regulatory Rapporteur (the journal produced by The Organisation for Professionals in Regulatory Affairs - TOPRA). This article highlights the importance of confirming (and agreeing on) a product's identity especially when one product can have two or even three different identities!


The category of borderline products is an increasingly challenging area to work with.  More combined products are entering the marketplace (such as drug-device combinations) and whole new product categories have been created e.g. electronic cigarettes (“e-cigarettes”). This article provides a definition of borderline products and offers insight into the importance of confirming a product’s status i.e. its identity and how to establish this status through interpretation of a few key criteria.  The discussion of practical examples provides further clarity.


Please click on this link to access the article.