Due to contradictory jurisdictions and ever-changing medical device regulations, the field of borderline products is becoming increasingly complex. The approval strategy for a product must unambiguously (even in borderline cases) demonstrate how the respective product should be classified, e.g., as a medical device, medicinal product, cosmetic, or biocide. Our team has extensive experience in dealing with such cases and remains a reputable partner in the field.
Our borderline product services also include demarcating and identifying the best processes to achieve market clearance, CE certification of drug-like medical devices, and the switch from medicinal product to medical device. Particularly for drug-like medical devices, our teams are up to date on current legislation processes both nationally and internationally.
We provide expert services based on our reliable partnerships and cooperation with highly specialized lawyers, supervisory authorities, and notified bodies.