Drugdu.com expert's response:

IVD Self-testing products are classified as Class C under IVDR by default (except for urine glucose/red blood cell/white blood cell/bacteria tests, which are Class B). About 80% of IVD products require Notified Body (NB) review, and self-testing products are almost all in this category. The documentation volume is large, the review cycle is long (Class D can take 18–24 months), and the core difficulties focus on usability studies, clinical performance evidence, and IFU label compliance.

I. Mandatory Documentation Checklist

1. Technical Documentation (core, approximately 20+ items)

Table of contents (version status, cross-references); manufacturer name and address, product name (all models/specifications), product description (intended use, model list, photos, drawings); device sample identification, declaration of conformity; list of applicable standards, essential requirements checklist (Annex I); risk management report (EN ISO 14971); product history (sales, complaints, change records); manufacturing method (production flowchart); quality control process description (incoming/in-process/final inspection, batch release criteria); process validation, controlled processes, packaging validation; labels and instructions for use (IFU); stability studies (individual components/after dilution/after opening, including test plan and acceptance criteria); software validation (if applicable).

2. Performance Evaluation Report (full set required for Class C)

Pre-clinical evaluation: plan/execution/evaluation/report/update, including literature search, laboratory testing, simulated use testing, and interface with risk management. Clinical evaluation: Clinical Evaluation Plan (CER Plan), literature search methodology, clinical study/verification, equivalence argument, Clinical Evaluation Report (CER). Post-market clinical follow-up (PMCF plan/report).

Must cover at least 12 performance indicators including precision, accuracy, specificity, sensitivity, linear range, and repeatability. Class C and D products must also include clinical sample data from European populations.

3. Usability Study Report (the lifeline for self-testing products)

This is the most unique requirement that distinguishes self-testing products from professional IVDs. You must prove that a layperson can obtain reliable results in a real-world use environment.

Specifically required: result concordance rate between lay users and professionals; questionnaire-based assessment covering different age groups and education levels, addressing scope of application, sample type, precautions, and result interpretation; subjects must be representative with adequate sample size; if using leftover samples, GDPR and ethics review requirements must still be followed; comply with IEC 62366-1 usability engineering standard.

4. Labels and Instructions for Use (IFU) — a key review item for self-testing products

IVDR imposes mandatory IFU requirements for self-testing products: sample type required for testing (blood/urine/saliva, etc.); additional materials needed to ensure proper use; contact information for further advice; limitation information: age, sex, menstruation, infection, exercise, fasting, diet, medication, etc.; result interpretation guidance (understandable by laypersons); actions to take based on test results (intervention/recommended action/seek medical attention); product name must not imply uses beyond the intended purpose (e.g., "COVID-19 test for ages 12+" cannot be written as "all ages").

5. Quality Management System Documentation (ISO 13485)

Quality manual, procedure documents, record documents; personnel qualification and training records; non-conforming product management records.

6. Others

EC Representative agreement (signed and stamped); UDI labeling (Class C/D must be registered in EUDAMED database); EC Declaration of Conformity; third-party test reports (if any); clinical report (literature on similar products or own research).

II. Five Major Review Difficulties (Especially for Self-testing Products)

Difficulty 1: Usability Study — the most frequently rejected item

The Notified Body will strictly review whether lay users can operate correctly and interpret results. Many companies substitute laboratory data for real-world use environment studies and get rejected outright. Recommendation: start usability studies early in product development, do not wait until just before submission.

Difficulty 2: Misclassification — one mistake, everything gets delayed

IVDR classification rules have 18 criteria (Annex VIII). Self-testing products default to Class C, but urine four-item tests are Class B. COVID-19 antigen tests moved from Class A under IVDD to Class C under IVDR. Some companies declared Class D tumor markers as Class C and got rejected, causing a 6-month delay. Always verify against the rules item by item; for complex products, request a pre-classification from the NB first.

Difficulty 3: Clinical Performance Data — European population data is a hard requirement

Class C self-testing products must provide clinical sample data from European populations. Many companies only have domestic data, which gets rejected due to insufficient regional applicability. Solution: collaborate with EU clinical institutions for multi-center testing, or supplement with literature review of comparable product performance data.

Difficulty 4: Notified Body Resource Bottleneck — long queues, high standards

There are fewer than 20 IVDR Notified Bodies worldwide. Class D queue times are 9–12 months, and Class C self-testing products also need 6–12 months. NBs have extremely high demands on technical documentation logic; duplicate submissions or redundant reports trigger multiple revision requests. Recommendation: start at least 12 months in advance, prioritize NBs with IVDR self-testing product review experience.

Difficulty 5: IFU Readability — reviewed from a layperson's perspective

The IFU for self-testing products is not written for engineers. The NB will review from the perspective of "a complete layperson with zero medical knowledge": Can they understand it? Can they collect the sample correctly? Can they interpret the result? Do they know what to do next? Any ambiguous wording can become a reason for rejection.

III. Practical Recommendations

Confirm classification (cross-check against Annex VIII 18 rules) → complete at project initiation stage.

Launch usability study (IEC 62366-1) → start early in development.

Pre-consult with NB on review path → at least 12 months in advance.

Prepare technical documentation (modular, pre-review each module) → 6 months before submission.

Supplement European population clinical data → 3 months before submission.

EUDAMED registration (Class C/D) → complete before market launch.