Regulatory affairs for combination products
A particular challenge in EU approval is posed by products that contain both a medicinal product and a medical device component. Such combination products are subject to both medicinal product and medical device regulations. The authorisation process is based on the component which has the primary effect.
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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