Our services for combination products

Whether a product is a "medical device with an integral medicinal product component" or a "medicinal product with an integral medical device component" determines the type of authorisation - and the sequence in which the necessary regulatory steps must be taken. We support you in clarifying demarcation issues and in efficient project planning to meet the complex requirements.

  • Support on demarcation issues, classifications, compliance with requirements of the respective corresponding regulations
  • Consultation, preparation, evaluation of documentation and expert reports
  • Biological evaluations
  • Clinical evaluations
  • Experimental and analytical work for proof of conformity
  • Organisation of and support during consultations with authorities
  • Organisation of and support during pre-assessments with appointed bodies
  • Execution of the consultation or certification process
  • Preparation of position papers to classify borderline products




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