New EU MDR Workshop For Medical Device Companies

IMDMC invites you to attend a special workshop hosted by Maetrics experts Mike Wolf and Scott Edwards who will discuss details on how the new EU MDR will impact many critical processes in medical device and IVDR manufacturing. Their discussion will also include a review of the necessary resources required to support the new regulations and the tenants of what a robust roadmap looks like for implementing the required changes to address the regulations, including designating reliable and effective project managers to drive change.

The new regulations, published in May, replace the current Medical Device Directive (93/42/EEC), Device Directive (90/385/EEC), and the Directive on In Vitro Diagnostic Medical Devices (98/79/EC).

These regulations represent fundamental revisions to the previous Guidelines in order to establish a transparent, predictable and sustainable regulatory framework for medical devices, which will ensure a high level of safety while supporting innovation. The new regulations for medical devices allow for a three-year transition period following publication, and full implementation is planned for 2020. For in vitro diagnostic medical devices (DMDIV's), the regulations will fully take effect in 2022.