Liability - VDE Medical Devices and Software

Liability describes the legal responsibility for one’s actions and products. In terms of medical software product liability is of particular interest.

Medical apps or software: classification and approval as medical device
Software like a medical app that has a medical purpose is legally a medical device. This article gives an overview of the path from a software to a medical device with CE-marking.
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.
Product Liability and Medical Software: Fortunately You Can Insure Yourself
Software can be a medical device. This has considerable consequences for product liability. The good news: manufacturers can manage the risks.
Harmonized Standards for Medical Software
Harmonized standards are the first choice to achieve conformity with the EU MDR, but not all requirements are always covered.
CJEU Top Court Cases on Medical Devices
Regulatory requirements are also based on the interpretations of the legal framework by the European Court of Justice (CJEU).

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