Intended Purpose • VDE Medical Software

The intended purpose describes the use as specified by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation.

Risk Classification of a Medical App
Risk classification for medical apps has changed significantly with the European Medical Device Regulation. We give you an example!
ISO 14971 Risk Management in the Future
Safety risks have always been considered in risk management according to ISO 14971. But what is about upcoming security risks?
Traceability of Medical Devices
Traceability plays a key role in increasing the safety of medical devices. Now, Unique Device Identification (UDI) also applies in Europe.
Medical Device Classification: The Software Special
The EU MDR contains new rules for medical device risk classification. Stand-alone medical software usually ends up in higher classes.
Transition Period of the EU MDR: What Dates Manufacturers Need to Know
The new EU MDR is complex and challenges the manufacturers. We explain what you need to pay attention to in the transition period.

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