New European MD Regulation EU 2017/745
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
Price excluded 21% BTW