The easiest way may not be the best way.
The field of borderline products becomes more and more complex. Conflicting law decisions and changing regulations contribute to this increasing complexity. A medical device approach may compete with a drug, cosmetic, food or biocides classification. Our team has vast experience with a wide variety of borderline matters and can support you as a reliable partner.
Our service starts with the clarification of borderline issues, which includes amongst other topics the unambiguous classification of your product. Our activities also cover demarcation and identification of the correct procedures for marketing authorization of borderline products, as well as CE-marking of drug-like medical devices or the switch of drugs to medical devices. Our reliable partnerships and cooperation with lawyers, highly experienced in borderline issues and our established communication with Notified Bodies and Competent Authorities ensure our proficient service for your requirements.
