Medical Device Regulations And Development 2020/2021

MEDICAL DEVICE REGULATION AND DEVELOPMENT

Wednesday from 8:00 to 10:00 PM

1. Definition of Medical Device and difference from medicines, supplements, and other healthcare products
2. Different categories of Medical Devices
3. The class of risk of a Medical Device
4. General objectives of the conformity process of a Medical Device
5. Competent Authority for the Medical Device at National and EU level
6. The Notified Body, definition, and role
7. The regulatory framework from Directives to Regulations
8. Regulations 2017/745 and 2017/746
9. Guidelines (MEDDEV and ISO) for the development of medical devices-
10. The process of developing a Medical Device
11. The main phases and the technical and scientific documentation required
12. Elements of the main documentation required
13. Biological Evaluation Plan and Report
14. Risk Analysis
15. Clinical Evaluation Plan and Report
16. Post Marketing Clinical Follow Up
17. Most frequent situations in the development of a Medical Device

Key reference documents and websites

MDR 2017/745

MDR 2017/746