Mapping of Requirements to Document Sections
|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>
Describe the core medical functionality of your device and how it treats, diagnoses or alleviates a disease. Keep it high-level so that this description is true for as long as possible even when the device is updated.
Intended Medical Indication
Describe the condition(s) and/or disease(s) to be screened, monitored, treated, diagnosed, or prevented by your software. Importantly, also list exclusion criteria: Maybe patients with a certain diagnosis should not be using your device.
List anything that you want to explicitly exclude from your intended use.
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 in patients, so in that case, they don’t overlap. Some ideas for characteristics to describe: Age group, weight range, health, condition(s).
Describe the typical user of the software. Some ideas could be: Qualifications, prior training (for your software), technical proficiency, time spent using the software.
Use Environment Including Software/Hardware
Describe the typical use environment. What sort of devices is this running on? Does the software only run on one device or multiple devices? Is it loud and chaotic like in an emergency ward? How’s the lighting?
Also, add other software or hardware which is required by your device. Most commonly, apps require users to have a smartphone with a compatible operating system (iOS / Android).
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.
Part of the Body / Type of Tissue Interacted With
The device is stand-alone software. It receives input from the user and outputs information. It doesn’t come in contact with tissue or bodily fluids.
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.
Template Copyright openregulatory.com. See template license.
Please don’t remove this notice even if you’ve modified contents of this template.