The Egyptian Drug Authority (EDA) announced the conclusion of the training program on the upcoming changes to medical devices resulting from the implementation of the European Medical Device Regulation (MDR 2017/745), particularly regarding medical device variants.

The training program aimed to clarify the procedures and regulatory requirements governing amendments to registered medical devices in light of the MDR 2017/745, while providing a detailed explanation of the latest updates in submission steps — contributing to facilitating procedures and expediting registration processes.

The program also included a presentation on the structure of the submission file, its evaluation mechanisms, and the roles of medical device companies and manufacturers within this framework.

This initiative comes as part of the Egyptian Drug Authority’s commitment to strengthening continuous and effective communication with medical device companies and manufacturers, and to supporting digital transformation, in line with Egypt’s Vision 2030.