Mapping of Requirements to Document Sections
Only relevant if you’re aiming for MDD (and not MDR) compliance:
|MDD Class||MDD Section||Document Section|
|IIa, IIb, III||Annex II, 3.2 c)||(All)|
|I||Annex VII, 3||(All)|
And vice-versa, only relevant if you’re aiming for MDR (not MDD) compliance:
|MDR Class||MDR Section||Document Section|
|(All)||Annex II, 1.1 a) - d), h), i)||(All)|
|ISO 14971:2019 Section||Document Section|
|IEC 62366-1:2015 Section||Document Section|
- Name: <product name>
- Version: <product version>
- Basic UDI-DI: <insert UDI-DI, if/when available>
Intended Medical Indication
Describe the condition(s) and/or disease(s) to be screened, monitored, treated, diagnosed, or prevented by your software.
Describe the patient population your software is intended to be used on. Note that this may overlap with the user profile (section below), but not necessarily. Your software could be used by physicians to diagnose diseases on patients, so in that case, they don’t overlap. Some ideas for characteristics to describe: Age group, weight range, health, condition(s).
Part of the Body / Type of Tissue Interacted With
Should be self-explanatory.
Describe the typical user of the software. Some ideas could be: Qualifications, prior training (for your software), technical proficiency, time spent using the software.
Describe the typical use environment. What sort of devices is this running on? Does the software only run on one device or on multiple devices? Is it loud and chaotic like in an emergency ward? How’s the lighting?
It’s kind of a stretch to describe the “operating principle” of software. I guess this makes more sense for hardware devices. In any case, I’d just generally state what sort of input goes in and what output comes out, e.g. you could be processing images and returning diagnoses.
The device is stand-alone software. It receives input from the user and outputs information.
Variants / Accessories
Describe variants and/or accessories of/to this device, if applicable. For typical stand-alone software of startups, this shouldn’t be applicable.
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