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MDR Article 2.12 defines “intended purpose” as: “the use for which a device is intended”. That statement is quite circular for a definition.
Offer a systematic approach to data collection but may intersect with clinical investigations, depending on their content, methodology, and purpose.
Rule 11 consists of three parts. This part provides the general classification rules for software with diagnostic and therapeutic purposes.
we analyze the “reality” of the application of Rule 11 on the market, providing practical tips and warnings with an eye to the future