| Regulatory References | |
|---|---|
| ISO 13485:2016 | 4.2.3 |
| ISO 20417:2021 | All |
User Manual [Insert Product Name]
Version: [Insert Content]
Date: [Insert Content]
[Placeholder for Company Address]
Email: [Insert Content]
Website: [Insert Content]
[Placeholder CE Sign]
[Placeholder UDI]
[Insert Product Name] is a Class [Insert Content] medical device in compliance with either 93/42/EEC (for MDD) or Regulation (EU) 2017/745 (for MDR).
UMDNS Code: [Insert Content]
Symbols
Safety Information
[Placeholder Symbol]
This symbol highlights important safety-related information.
Additional Information
[Placeholder Symbol]
This symbol points to supplementary details.
Include explanations of all symbols used throughout the manual, adhering to relevant standards such as ISO 15223.
General Provisions
Instructions for use fall under Section 13 of the Essential Requirements (MDD) and Chapter 3, Section 23 of the General Safety and Performance Requirements (MDR). You may argue that no instructions for use are required for Class I or IIa devices, provided they can be used safely without them. This is stipulated in Section 13.1 (MDD) or Section 23.1.d (MDR):
“By way of exception, no such instructions for use are needed for devices in Class I or IIa if they can be used safely without any such instructions.”
Language Requirements
Language requirements are determined at the national level. German Medical Device Law (MPDG, Article 8) generally mandates instructions in German. However, exceptions may allow English or another easily understandable language for professional users. Safety-related information must always be available in German:
“In justified cases, the information may also be provided in English or another language easily understood by the user of the medical device, provided the information is intended exclusively for professional users, and safety-related information is also available in German or the user’s language.”
Reference: MPDG
Product Description
Intended Medical Indication
Include a summary of your product’s purpose, describing the medical conditions or diseases it addresses, expected clinical benefits, data types processed, and relevant functionalities (e.g., algorithm accuracy for machine learning-based devices).
Characterization of User Profile
Describe the expected user base, their educational background, familiarity with the device’s field, technical expertise, and typical usage duration. Include details of any training provided before use.
Characterization of Patient Population
Specify the intended patient population, including factors such as age group, health conditions, and other relevant characteristics.
Use Environment & System Requirements
Explain the device’s operating environment, including hardware and software requirements, such as supported operating systems or smartphones. Include notes on conditions like noise levels and lighting.
Exclusions
Clearly state where and by whom the device should not be used.
Safety Information
Contraindications
Detail any specific clinical or safety risks, emphasizing situations where the device should not be used.
Warnings & Remaining Risks
Provide information for risk mitigation, such as checking for completeness and accuracy before operation.
Reporting a Serious Incident
Users should report serious incidents involving this device to their national competent authority. Provide contact information for each relevant country.
Language Options
Specify the languages available for your product, including safety-critical information in compliance with local regulations.
System Requirements
Hardware Requirements
Detail the minimum hardware specifications needed to operate the device.
Software Requirements
List required software configurations, such as operating system versions or browser compatibility.
IT Security Measures
Describe necessary measures to secure user data and prevent unauthorized access, like firewalls and VPN setups.
Installation
Provide a step-by-step installation guide, including IT integration requirements and credential management.
Safety and Maintenance
Lifetime & Updates
Specify the device’s expected lifetime (e.g., three years) and how updates are deployed to adapt to technological advancements or cybersecurity changes.
Incident Reporting & Support
Explain procedures for reporting malfunctions, incidents, or security breaches, as well as recovering lost credentials.
Additional Sections:
– User Guide: Step-by-step instructions with screenshots.
– Algorithm Description: For machine learning devices.
– Alternative Devices/Services: Relevant options, if applicable.