Significant regulatory changes came along with the EU Medical Devices Regulation (MDR) 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, devices provided in combination with drug products, devices combining software and medicinal products, and devices associated with natural substances.
- Gives hands-on insight on how to achieve compliance and the requirements for regulatory documentation and CE marking