This course is designed into seven sections. The purpose of the course is to explain the medical device regulation 2017/745 in simple terms for a better understanding and to help regulatory affairs professionals (Regulatory Affairs officers, Regulatory and quality Engineers, students in regulatory affairs, students in biomedical engineer, consultants in medical devices field and some professionals who want to learn more about this new medical device regulation 2017/745) to implement this new European Union Medical Device Regulation 2017/745 in their different organizations. This course is presented as following:

-> Introduction: gives a brief introduction on this course

-> Module 1: presents the major changes on the European Union Medical Device Regulation 2017/745

-> Module 2: gives the main elements composing the technical documentation according to the Medical Device Regulation 2017/745

-> Module 3: explains different procedures for assessing conformity of a product according to the Medical Device Regulation 2017/745

-> Module 4: explains the key main steps to follow for CE marking Medical Device under the Medical Device Regulation 2017/745

-> Module 5: shows certain general obligations of economic operators according to the Medical Device Regulation 2017/745

-> And Conclusion: gives some important dates that economic operators (Legal Manufacturers, Authorised representatives, Importers, and Distributors) concern by the application of this new European Union Medical Device Regulation 2017/745 have to keep in to their mind with the view to achieve the implementation of this new regulation at the right time and definitely to be compliant at the end.