Instructions for Use (IFU) and user manuals are essential documents for any medical device. They ensure the safe and effective use of the device by providing clear, step-by-step guidance to healthcare professionals and/or patients. While these documents are standardized to a certain extent, there are specific requirements to keep in mind when registering such products in Mexico.
IFUs vs. Manuals
The two primary types of documents found with medical devices are IFUs and manuals. While both are developed by technical and clinical experts early in the device’s lifecycle, they differ in scope and detail:
- IFUs: Typically shorter, providing concise step-by-step instructions on device usage.
- Manuals: More comprehensive and detailed, often accompanying complex devices like medical electrical equipment.
Despite the distinction, IFUs and manuals are often considered equivalent, as both provide detailed information on how to proper use certain type of device.
International Standards and Guidelines
Creating IFUs and manuals is not just a regulatory requirement, but also a basis of Quality Management Systems. This process involves Risk Management approaches and Good Manufacturing Practices to ensure patient safety.
Key international standards include:
- MDR (Medical Device Regulation): Article 2 (14) emphasizes the importance of IFUs in communicating intended use, correct usage, and precautions.
- ISO 20417:2021: Section 6.6 Provides detailed guidance on IFU development.
- EN 60601-1: Section 7.9.2 and Table C.5 outlines specific requirements of manuals for medical electrical equipment.
IFUs and Manuals in Mexico
In Mexico, IFUs are regulated by various guidelines, including NOM-241-SSA1-2021, the Regulation on Health Supplies, and the Supplement of Medical Devices of the Mexican Pharmacopoeia.
The “Guide to Obtain Sanitary Registrations of Class I, II and III Medical Devices” offers the most practical guidance on meeting COFEPRIS expectations. It outlines the minimum sections that IFUs and manuals must contain:
- Distinctive name and generic name
- Description
- Purpose of use
- Presentations
- List of components or parts
- Assemble and disassemble
- Operation, cleaning and sterilization
- Conditions of conservation and storage
- Maintenance
- Calibration
- Precautions
- Preparation
- Warnings and corresponding allusive legends
- Contraindications
- Adverse events
- Route of administration, dosage form and content of active ingredient.
- Surgical technique
Note: Some items may not be applicable to all types of devices.
It is fundamental to mention that IFUs and manuals must be in Spanish for the Mexican market. Although COFEPRIS checks for the inclusion of required sections, it does not evaluate the accuracy or validity of the information provided. The responsibility for accurate and comprehensive content lies with the manufacturer.
Conclusions
IFUs and manuals are essential documents for all medical devices. By adhering to international standards and understanding local regulations, medical device manufacturers can ensure a smooth registration process in Mexico.
If you need expert advise on how to prepare your IFUs and manuals for COFEPRIS submissions, please contact us at contact@veraqueconsulting.com.
