Medical Device Regulations And Development 2021/2022

MEDICAL DEVICE REGULATION AND DEVELOPMENT

Wednesday from 11:00AM to 1:00 PM

Calendar of the lessons year 2021/2022

Nov 3rd 10th 24th

Dec, 1st . 15th

Jan 19th 26th

Feb 16th

The exam session will be held at the end of February 2022

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