Consulting

Strategic Planning for Compliance with the EU Medical Device Regulation

The changes are significant. Here’s what you must know.

Makers of medical devices must build compliance into product development to comply with the EU Medical Device Regulation (MDR). Our white paper looks at key rule changes under the MDR, such as an expanded definition of what constitutes a medical device, the increased need for clinical evidence that products are safe and work as intended, and new roles for notified bodies in clinical trials. Other topics include:

  • How the new rules reclassify risk in four categories that assess the probability and severity of potential harm to patients
  • New labeling requirements for Class I devices, especially reusable ones, that will make all current Class I labels obsolete
  • The importance of creating a transition leadership team involving regulatory, quality assurance, medical affairs, manufacturing, and other key expertise