Since June, 2016, a revision 4 of the MEDDEV 2.7.1 was published and replaces the version 2009. This document accompanies the spirit of the new Regulation of the medical devices which should be published during 2017.
It is important that the manufacturers of medical devices use and master this document of orientation and best practice within the framework of the evaluation of the clinical data. Indeed, this one contains strengthened provisions to perfect the demonstration of the conformity with the essential requirements relative to the performance and to the clinical safety of medical devices, in the more general purpose to protect the health of the population.
During this webinar, the following issues will be discussed:
- Novelties of the version 4 of MEDDEV 2.7.1
- Update of the quality documents of LNE/G-MED