There has been another ruling in the legal tussle over the classification under the Medical Device Regulation of an app that some contend is not even a medical device.
Dermanostic: A Legal Guinea Pig Impacted By MDR’s Regulatory Gaps?
How MDR's Lack Of Clarity Is Destabilizing Innovation
With the latest ruling in Germany, there is speculation that the Medical Device Regulation’s confusing Article 11 on software or the device’s timing of gaining its class I category may be to blame for the invidious position Dermanostic has found itself in.
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