MDR Guide for Medical Device Software
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.
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The Guide intends to:
- 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.
- 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.
- Explain the key concepts of the MDR
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