Drugdu.com expert's response:

The EU In Vitro Diagnostic Regulation (IVDR) imposes comprehensive and stringent regulatory requirements on self-testing and point-of-care testing (POCT) products, covering aspects such as classification management, technical documentation, labeling and instructions, conformity assessment, and post-market surveillance. The specifics are as follows:

I. Classification Management: Scientific Risk-Based Grading

The IVDR classifies in vitro diagnostic products into four categories—A, B, C, and D—with risk levels increasing sequentially. Self-testing products are typically categorized as Class C, with the following exceptions:

Class B Self-Testing Products: Examples include pregnancy tests, ovulation tests, cholesterol detection reagents, and tests for glucose, red blood cells, white blood cells, and bacteria in urine.

Class C or D Special Self-Testing Products: Products used to detect sexually transmitted pathogens, blood or tissue typing, or where erroneous results could lead to death or severe disability may be classified as Class C or D.

II. Technical Documentation and Performance Evaluation: Ensuring Scientific Validity

Manufacturers are required to compile detailed technical documentation, including:

Performance Evaluation Report: Covering scientific validity, analytical performance (e.g., accuracy, precision), and clinical performance (e.g., diagnostic accuracy).

Clinical Evidence: Demonstrating product performance through clinical performance studies or literature reviews, with particular attention to usage scenarios by non-professional users.

Risk Management File: Systematically assessing risks throughout the product lifecycle and developing mitigation measures.

III. Labeling and Instructions: Clarity and Comprehensibility to Ensure User Safety

Labeling Requirements:

Indicate "Self-testing" and the sample type (e.g., blood, urine).

Provide a list of additional materials required for testing and contact information for obtaining assistance.

Use icons compliant with EN ISO 15223-1 standards to ensure intuitive information.

Instructions Requirements:

Written in an official EU language, covering:

Intended use and medical background explanation.

Test limitations and handling measures for unexpected results.

Behaviors or information that may affect results (e.g., diet, medications).

Whether user training or specific qualifications are required.

IV. Conformity Assessment: In-Depth Involvement of Notified Bodies

Assessment Process:

Annex IX Process: Review of the manufacturer's quality system and technical documentation (e.g., test reports on intended users, data demonstrating product suitability for intended use).

Annex X Combined with Annex XI Process: Quality management system assessment focused on production.

Role of Notified Bodies:

Conduct 100% technical documentation assessments for Class B, C, and D self-testing products and issue CE certificates (including quality management system and technical documentation assessment certificates).

Ensure product compliance with IVDR requirements before manufacturers can affix the CE mark and notified body identification number.

V. Post-Market Surveillance: Continuous Tracking and Improvement

Post-Market Surveillance Plan (PMS Plan): Required for all product categories, defining data collection and safety monitoring strategies.

Periodic Safety Update Report (PSUR): Annual submission required for Class C and D products to update performance and safety data.

Post-Market Performance Follow-Up (PMPF): Class C and D products must actively collect and analyze post-market performance data to support product improvements.

Unique Device Identification (UDI): Enabling Full Lifecycle Traceability

UDI Requirement: Each self-testing product must be assigned a unique identifier and labeled on both the product and packaging.

Database Registration: Product information must be entered into the EUDAMED database, clearly indicating "self-testing use."

VII. Usability Studies: Ensuring Safe Use by Non-Professional Users

Study Content:

Verify whether non-professional users can correctly understand instructions and obtain reliable results.

Assess user comprehension of result interpretation and subsequent actions (e.g., isolation, seeking medical attention).

Special Considerations: POCT products must reference U.S. CLSI guidelines to ensure correct usage in non-laboratory environments.