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 |
|---|---|
| 5.2 | (All) |
| IEC 62366-1:2015 Section | Document Section |
|---|---|
| 5.1 | (All) |
Product Information
- Name: \
- Version: \
- Basic UDI-DI: \
Intended Use
Provide a high-level description of your device’s core medical functionality, outlining how it is designed to treat, diagnose, or alleviate a disease. Keep this broad enough to remain accurate through future updates to the product.
Intended Medical Indication
Specify the conditions or diseases your device is intended to address, such as screening, monitoring, diagnosis, treatment, or prevention. Also, highlight any exclusion criteria, such as conditions or patient profiles for which the device should not be used.
Contraindications
Clearly list scenarios or conditions where the device should not be used to ensure safe and effective operation.
Patient Population
Define the target patient population for your device. This could include age range, weight, health conditions, or any other relevant demographic or clinical details. Keep in mind that the patient population may differ from the user profile.
User Profile
Describe the typical users of the device. Include details such as required qualifications, prior training specific to your software, technical expertise, and the amount of time they are expected to spend using the device.
Use Environment (Including Software and Hardware)
Provide details about the device’s typical use environment. For instance, does it operate in a quiet office or a busy emergency ward? Mention factors such as lighting and noise levels.
Additionally, list any required hardware or software for operation. For example, apps may need a smartphone running a compatible operating system (e.g., iOS or Android).
Operating Principle
While software devices typically lack traditional “operating principles” associated with hardware, describe the general process. For instance, state what input data is used (e.g., user inputs or image files) and what output the device provides (e.g., diagnostic results).
The device operates as standalone software, receiving input from the user and producing informational output.
Part of the Body or Tissue Interacted With
The device is standalone software and does not interact with body tissue or fluids. It solely relies on user-provided input and generates corresponding information.
Variants and Accessories
If your device has variants or accessories, describe them here. For standalone software products, this section is often not applicable.