Drugdu.com expert's response:

Core Requirements for Product Instructions under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) to Ensure Safety, Effectiveness, and Proper User Application

I. Basic Information Requirements

Manufacturer and Authorized Representative Information

Must include the manufacturer’s full name, address, and the name and address of the EU authorized representative (if the manufacturer is located outside the EU).

Example: If the manufacturer is based in China, the EU authorized representative’s contact details must be clearly indicated.

Product Identification and Classification

Must specify the product name, model number, unique device identifier (e.g., UDI code), and IVD product classification (Class A/B/C/D).

Example: The front page of the instructions should clearly state: "Product Name: XX Blood Glucose Meter, Classification: Class B."

CE Marking and Compliance Statement

Must include the CE mark and indicate compliance with IVDR requirements.

Example: Display "CE 2017/746" prominently on the cover or a visible location, along with the compliance declaration number.

II. Content Detail Requirements

Intended Use and Target Population

Must provide a detailed description of the medical context, applicable symptoms, detection targets (e.g., pathogens, genetic mutations), and target users (e.g., pregnant women, diabetic patients).

Example: Clearly state: "This product is intended for quantitative detection of glucose concentration in whole blood and is suitable for self-monitoring by patients with Type 2 diabetes."

Performance Characteristics and Clinical Evidence

Must provide key performance parameters such as sensitivity, specificity, and accuracy, supported by clinical validation data or literature.

Example: List: "Sensitivity: 99.5% (95% CI: 98.2%–100%), validated with 200 clinical samples."

Operating Procedures and Sample Handling

Must provide step-by-step instructions, including sample collection, processing, testing procedures, and result interpretation.

Example: Detail: "After collecting a blood sample from the fingertip, place the blood into the test card’s sample well and wait 10 seconds to read the result."

Risk Information and Preventive Measures

Must list potential risks (e.g., false positive/negative results), contraindications (e.g., prohibited for patients with severe infections), and emergency response measures.

Example: Warn: "If results do not align with clinical symptoms, consult a physician immediately and do not adjust treatment plans independently."

III. User-Friendliness Requirements

Multilingual Support

Instructions must be provided in the language(s) of EU member states or the sales region to ensure user comprehension.

Example: If sold in Germany, a German-language version of the instructions must be provided.

Readability and Formatting Standards

Use concise language, avoid technical jargon, and include illustrations or tables where necessary to aid understanding.

Example: Use flowcharts to depict operating steps or tables to compare interpretations of different test results.

Explanation of Symbols and Abbreviations

Define symbols (e.g., warning signs, CE mark) and abbreviations (e.g., UDI, IVD) used in the instructions.

Example: Note in the footer: "UDI: Unique Device Identifier, used for product traceability."

IV. Compliance and Update Requirements

Regular Updates

Instructions must be updated periodically to reflect product improvements or regulatory changes, ensuring information remains current.

Example: If clinical validation data is updated, revise performance parameters in the instructions accordingly.

Electronic Labeling and Accessibility

Electronic instructions are permitted but must ensure users can easily access, print, or save them.

Example: Include a QR code in the product packaging for direct download of the electronic instructions.

V. Special Scenario Requirements

Self-Testing IVDs

Must provide additional information on test limitations, guidance for unexpected results, and user training requirements.

Example: Clearly state: "This product is intended for non-professional use only. Watch the training video before use."

In-House IVDs

For devices developed and used internally by healthcare institutions, demonstrate that no equivalent product is available on the market and comply with specific exemption criteria.

Example: Note in the instructions: "This device is for internal use only at XX Hospital and must not be commercially distributed."

Summary

The IVDR’s requirements for product instructions cover three key dimensions: information completeness, user-friendliness, and compliance. The primary goal is to safeguard patient safety, enhance product traceability, and minimize usage risks. Manufacturers must strictly adhere to Annex I, Section 20 of the IVDR and the EN ISO 18113 series standards to ensure instructions are accurate, clear, and compliant with the latest regulations.