Conformity Assessment • VDE Medical Software

‘Conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled (Art. 2 (40) EU MDR)

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!
Technical Documentation: See the Opportunities, not the Challenges!
The technical documentation of medical devices in the EU must be revised. We tell you what to keep an eye on and how to make it a success!
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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