Medical Devices
Companies selling and manufacturing medical devices encounter a complex legal system of European and national regulations. In addition, the rules and regulations on medical devices are constantly being reformed and thereby result in new issues, e.g. with regard to conformity assessment procedures and clinical evaluations. Further, issues relating to the classification, labeling and advertising of medical devices have to be dealt with.
We provide comprehensive consulting services, in particular on the following topics:
- Advice during the early phase of product development and product launch
- Clarification of boundary issues (medical products / pharmaceuticals / biocidal products / cosmetics), combination products, classification
- Legal advice on the marketability of medical products
- Issues related to conformity assessment procedures, certification, accreditation, clinical evaluation, quality management and quality assurance, data protection
- Advice on the labeling and advertising of medical devices
- Development and support of special cooperation and distribution models, contracts
- Specific advice on cross-border trade
- Competitive and professional representation in litigation, particularly in relation to warnings from competitors and trade associations
