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Medical Device Directive (n.) | international…

Medical Device Directives refer to the requirements a medical device manufacturer must meet in order to market a product outside the U.S. These requirements vary not only by region, but with the device classification as well (which is largely based on level of risk). In the European Union, conformity to the essential requirements of MDD for a specific device is indicated by the presence of the CE mark. Assessment and certification in the European Union are performed by a “Notified Body,” an independent organization nominated by a member government and notified by the European Commission.

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While marketing a medical device outside the U.S. presents valuable opportunities, preparing to take advantage of those opportunities depends on understanding the rules and integrating additional processes. It can all feel like you’re trying to learn a foreign language.

If you need help telling your MDD from your ISO, contact AlvaMed. Our knowledge and experience are coupled with solid relationships with Notified Bodies, government agencies and Authorized Representatives around the globe. We can interpret the language, help you design an MDD strategy, identify gaps in your existing process, develop documentation, or align your teams and departments—so you can begin your travels, efficiently and effectively, along the international pathway.

Click here to begin a conversation or call 781-710-2418.

Email us at info@alvamed.com.