The New European Regulation (MDR) from a Notified Body Perspective

On May 25th2017, the new MDR kicked in. Starting from May 26th 2020, MDR is replacing the Directive 93/42/EEC. Manufactures have to comply with the new standards as soon as possible. ECM, in quality of Notified Body, will provide an overview on the incoming news. In particular, it will address:
- Major differences between MDD and MDR, with a focus on clinical evaluation;
- The role and expectations from Notified Bodies;
- Best practices for manufacturers: don’t fear, engage instead.