Expert Reports on Demarcation and Classification

Medicinal products and medical devices are governed by different legal frameworks in Europe. Your challenge as a manufacturer is the regulatory classification of your product. This requires accurate demarcation at an early stage of development.

As a result the analyses necessary for confirming marketability differ totally for these two product categories. For combination products, which consist of a drug component and a device component, it is also necessary to clarify by which directive the product is regulated.

Our expertise lies in both, the marketing authorisation of medicinal products and the certification of medical devices. You are welcome to benefit from our experience in the

  • compilation of expert reports on demarcation to be presented to authorities or Notified Bodies
  • discussion and decision-making concerning demarcation and classification issues for your product
medical device
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