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Appointing an Authorized Representative (AR) in Germany is a mandatory requirement under EU MDR 2017/745 for all medical device manufacturers based outside the European Union. Germany, being the largest medical device market in Europe, serves as a strategic entry point for market expansion—but only with proper regulatory representation in place. A qualified Authorized Representative in […]

Medical Device Registration in Germany: How to Get CE Marking Right ​ Launching a medical device in Germany is a strategic move—this market is not only the largest in Europe but also known for its strict regulatory standards and strong demand for quality healthcare solutions. However, before your product can be sold or used in