Intended Purpose - VDE Medical Devices and 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.

Clinical Evaluation of Medical Devices
Get an overview of the most important elements of a clinical evaluation of medical devices according to the EU Medical Device Regulation (MDR).
Risk Management for Medical Devices: ISO 14971
The risks of a medical device must be acceptable in comparison to its benefits. Manufacturers must therefore carry out a risk management process. Read how this works in this article.
Software Classification: Insights in EU Guidance
The MDR caused uncertainty concerning software classification. We give you an exclusive insight into the upcoming EU guideline!
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!
Market Access for Artificial Intelligence in Medicine
How does current regulation for market access fit with artificial intelligence in medicine? Find out more by a practical example.

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