Significant regulatory changes are coming along with the EU Medical Devices Regulation 2017/745 (MDR) and evolutions affecting pre-clinical and clinical modules of medical device dossiers, their market approval process and notified bodies involved in the conformity assessment. Also, due to research and innovation, the varieties of Device Drug and Drug Device Combination Products is growing.
- Gives you an overview of the requirements for combination products under the MDR
- Guides you through the regulatory conformity pathways for combination products
- Gives you a clear understanding of the regulatory requirements for devices containing medicinal substances and devices provided in combination with drug products
- Gives hands-on insight on how to achieve compliance and the requirements for regulatory documentation and CE marking