New European MD Regulation EU 2017/745

Nr: 2017745    

E-Learning course
Slides

You will understand how the new European Medical Device Regulation was developed and when it will be fully applicable.  Where you can find why this new regulation was developed; what the content is of its 10 chapters and how it needs to be applied per the 17 annexes. You will understand the major changes of this new regulation. A life-cycle approach is implemented with the incorporation of European guidance (MEDDEVs) into the Regulation: Guidance on Authorized Representation, Clinical Evaluation, Vigilance, and Post-Market Clinical Follow-Up has been integrated into the MDR.  New processes, new terms and acronyms are shown. The many post-market changes are discussed. The roles and responsibilities of the economic operators are presented. Finally a timeline of the implementation is shown. A lessons learned concludes this e-learning course.

3 hours to understand and practice content

E-Learning, includes examination