Blog posts

Words elicit emotions—a concept often exploited by politicians and marketing professionals. The higher the stakes, the higher the emotional impact of words. In medical device regulatory affairs the stakes can be substantial.

Few parts of the MDR have sparked as much discussion as Rule 11. This is not surprising. Software fundamentally defies traditional methods of categorizing medical devices into established groups. Each software device is unique, impacting clinical decision-making in very specific ways.

MDR Article 2.12 defines “intended purpose” as: “the use for which a device is intended”. That statement is quite circular for a definition. While the remainder of Article 2.12 emphasizes the need of consistency between information material, clinical data and intended purpose, it still does not provide much help when it comes to building an intended purpose for CE-certification. However, there is no reason to despair.

This series of articles on systematic searches and reviews seeks to address the gap left by current regulations and standards within the EU and globally.