• Regulatory Affairs
  • Medicinal products and medical devices combined

Medicinal products and medical devices combined

Products that include a medicinal product and medical device portion present a particular challenge in the EU.

These combination products are subject to either medicinal product regulations or medical device regulations – irrespective of which component has the primary effect. The requirements of the corresponding regulations must be met; which makes the documentation and evaluation process extremely complex.

Our services:

  • Support on differentiation issues, classification, compliance with requirements of the respective corresponding regulations
  • Consultation, preparation, evaluation of documentation and expert reports
  • Biological and clinical evaluations
  • Experimental and analytical work for proof of conformity
  • Support during consultations with authorities
  • Execution of the consultation or certification process
  • Preparation of position papers to classify borderline products

#combinationproducts

Dr. med. Christian Schübel
Clinical Affairs/Medical Devices

Phone: +49 89 2000203-52
Email:

Dr. Verena Peter
Quality/CMC

Phone: +49 89 2000203-71
Email:

Contact us. We’re happy to help!

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08:00 - 17:00 o´clock

+49 7272 7767-0