2014, November

Software (embedded, standalone, Apps) has become more important in the medical field. Medical software is nowadays essential because of its multiple purposes in diagnostic, therapy, monitoring and others, and must meet the Medical Device Directives essential requirements before being placed on the market.

Like all medical devices, software must be classified to choose the route to demonstrate compliance with the Directive. However, the software classification rules were designed in the 1990s, so they may be difficult to apply to 21th century medical software. For this reason, the European community published an interpretive guidance (MEDDEV) for software classification specifically.

Understanding how your software is classified is essential for the success of your device in Europe and to ensure the software complies with the Directive. Classification allows you to determine what would be the control level of the Notified Body.


Franck MARTIN Senior QA RA Consultant and CEO of ExpeReg

Sarah STEC Legal and Regulatory Director, G-MED North America

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