intended purpose

Monitor showing an ECG heartbeat line, a x-ray image of a hand and a graph, symbolizing medical stand alone software or Software as Medical Device (SaMD). Monitor showing an ECG heartbeat line, a x-ray image of a hand and a graph, symbolizing medical stand alone software or Software as Medical Device (SaMD).

Stand-Alone Software as Medical Device

Thorough analysis of the intended purpose provides essential evidence for stand-alone software being a medical device on its own.

Tree Model for Classification Tree Model for Classification

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.

Person with a broken leg and a broken arm, money flying around him, symbolizing product liability with medical devices Person with a broken leg and a broken arm, money flying around him, symbolizing product liability with medical devices

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.

European flag with scale symbolising CJEU European Court of Justice European flag with scale symbolising CJEU European Court of Justice
2019/01/07 - Regulatory Affairs - Updated: 2019/11/28 - Thorsten Prinz

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).