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MDR Guide for Medical Device Software

Medical Device

The Medical Device Regulations (MDR) is required from 26 May 2021 for all Medical Devices in Europe. The MDR has a huge impact on App developers and Medical Device Software manufacturers. The MDR brings many new requirements and often also more stricter requirements because of up-classifications. The MDR introduces an extension of the definition of software as a medical device.  Software devices that falls under the scope of this definition is Medical Device Software as a module of a software solution or as an accessory to a Medical Device.

(version 1.0 16 July 2021)

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The Guide intends to:

  1. Provide an overview of the qualification steps of the MDR. Qualification is the process of determining if software is a medical device according to the MDR and should therefore follow the requirements of the MDR. This software is then called Medical Device Software.
  2. Bring an explanation of the steps and challenges for a (Start-Up) Software Manufacturer to successfully place a Medical Device Software on the market under the MDR. A companion document for in house-made Software will be made separately available.
  3. Explain the key concepts of the MDR