EU Medical Device Regulation

The EU MDR of April, 5, 2017 is at the link below.  Clause (19) states:

“It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software’s location or the type of interconnection between the software and a device.”

Article 2 Definitions mentions software several times as well as interoperability.

Annex I General Safety and Performance mentions risk of negative interaction between software and IT environment and other requirements for software including mobile computing for security development life cycles risk management and V&V.

Annex VI UDI Clause 6.5 defines UDI requirements related to software including the requirement display of the UDI, when changes are made to the software, and how the UDI is displayed or placed on labeling.

Annex VII indicates software that drives or influences a device is classified the same as the medical device .Rule 11 sets classification requirements for standalone software (SaMD) Class I , IIa, II and III. This is different and not directly related to Safety classification in IEC 62304.

View the new regulation at

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62304, FDA, and Emerging Standards for Medical Device and HealthIT

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Dates:  February 4-6, 2020
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QSS Software Validation
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