Conformity Assessment Routes under the EU Medical Devices Regulation (MDR 2017/745)

Download our white paper on EU medical device conformity assessments routes under the MDR.

In this white paper, we explore options for conformity assessment routes under the EU Medical Devices Regulation (MDR 2017/745).

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European medical device compliance under the Medical Devices Regulation (MDR) means new conformity assessment route options. For medical devices that require NB involvement, a manufacturer may choose between different modules to demonstrate compliance and obtain CE Marking. If you plan to pursue CE Marking under the MDR, it's important to understand how conformity assessment routes have changed compared to the MDD.

In this white paper, we discuss some options, or differences, in selecting a route to conformity assessment for a particular device, including:

  • A brief overview of the MDR
  • A detailed look at conformity assessment routes by device class
  • Routes for new device classifications
  • and much more.

Download this paper for a practical guide to conformity assessment options under the MDR.