The course is aimed at those with regulatory knowledge in Pharma and a need for a better understanding of medical devices and the requirements of the European Medical Device Regulation (MDR).
Combination products are Pharma intended to be used in combination with a medical device. They belong to a group of products that are generally subject to more complex regulatory processes to achieve and maintain market status. Together with the implementation of the new European Medical Devices Regulation, the requirements for these devices are further tightened
This course gives you an introduction to the basic legal requirements for Pharma that are used in combination with medical devices ("Drug Device Combinations") and the most important changes that the new medical device regulations entail. After the training, you should have gained knowledge and clarification of the interaction between current legal requirements for Pharma and medical devices. The purpose of the training is to ensure regulatory compliance for combination products.
