New Responsibilities Shake Up MedTech
By Beth Crandall, Maetrics
The EU MDR has rendered compliance an issue of interest for specific entities with an economic interest in medical devices—grouped into the term “economic operators”. It introduces new regulatory requirements for two of the four entities that previously had no formal role in ensuring product compliance, namely importers and distributors. If the burden of compliance is now shared with more entities than just the legal manufacturer, many may be wondering if the industry is ready to meet these new requirements.