Drugdu.com expert's response:

Differences in Registration Application Requirements for In Vitro Diagnostic (IVD) Medical Devices between China and the European Union

The differences in registration application requirements for IVD medical devices between China and the European Union are mainly reflected in classification rules, conformity assessment paths, technical documentation requirements, quality management systems, clinical evaluations, and post-market surveillance and traceability. Here is a detailed introduction:

I. Classification Rules

China: Based on risk, IVD products are classified into Class I, II, and III. The classification rules are relatively clear, with reference to the detailed "Classification Catalog of In Vitro Diagnostic Reagents."

European Union (IVDR): Based on risk, IVD products are classified into Class A, B, C, and D (with risk increasing from low to high). The classification rules are more refined and stricter, following the rules in Annex VIII. A key change under the IVDR is that a large number of products that could previously be self-declared under the IVDD are now classified into higher risk categories, requiring the involvement of Notified Bodies (NBs). For example, most products targeting infectious diseases, blood screening, and tumor markers are classified as Class C or D high-risk products.

II. Conformity Assessment Paths

China

Registration for Class I Products (Filing): Submit filing materials to the municipal drug regulatory authority.

Registration for Class II/III Products: Submit a registration application to the Center for Medical Device Evaluation of the National Medical Products Administration. The process covers "testing (type testing) → clinical evaluation → registration application → technical review → administrative approval → issuance of the certificate." Class III products and some Class II products must undergo clinical trials (unless the product is included in the exemption catalog).

European Union (IVDR)

Declaration of Conformity (DoC): All products must sign this declaration.

Involvement of Notified Bodies: Except for Class A non-sterile products, Class B, C, and D products must undergo conformity assessment by a Notified Body. The assessment methods include document review, technical documentation review, and quality system review. The requirements for clinical evidence are extremely high, necessitating a detailed Performance Evaluation Report (PER) covering scientific validity, analytical performance, and clinical performance data. New products or high-risk products usually require clinical performance studies. Overseas manufacturers must appoint an EU Authorized Representative.

III. Technical Documentation Requirements

China: Registration application materials must be submitted, including summary materials, research on main raw materials, production processes, analytical performance evaluation, stability studies, clinical evaluations, etc. These materials have relatively fixed formats and catalog requirements.

European Union (IVDR): Technical documentation must be established, with requirements similar to those in China. However, there is a greater emphasis on "continuous updating" and "whole lifecycle management." Special emphasis is placed on the Performance Evaluation Report (PER), which is a core requirement of the IVDR. As a comprehensive document, the PER needs to be continuously updated. Post-market surveillance (PMS) plans and reports are required to be more systematic.

IV. Quality Management Systems

China: Must comply with the requirements of the "Good Manufacturing Practice for Medical Devices" and its appendices. The National Medical Products Administration conducts on-site inspections of Good Manufacturing Practice (usually for Class III products and some Class II products). Certification is granted only after passing the inspection.

European Union (IVDR): Must establish a quality management system that complies with the EN ISO 13485:2016 standard. Notified Bodies conduct quality system audits (usually on-site audits) as a prerequisite for issuing CE certificates.

V. Clinical Evaluations

China: Clinical evaluations are completed through clinical trials or comparison with similar products. There are clear "Guidelines for Clinical Trials of In Vitro Diagnostic Reagents" and a "Catalog of In Vitro Diagnostic Reagents Exempt from Clinical Trials."

European Union (IVDR): Performance evaluation is the core concept, including scientific validity (proving the association between the marker and the clinical condition), analytical performance (sensitivity, specificity, precision, etc.), and clinical performance (clinical sensitivity, clinical specificity, etc.). Higher levels of clinical evidence are required, with a greater tendency to require prospective clinical performance studies, especially for Class C and D products. The threshold for accepting comparison with similar products is higher.

VI. Post-Market Surveillance and Traceability

China: Requires the establishment of a post-market surveillance system, including adverse event monitoring and reporting, and product traceability. The "Administrative Measures for the Monitoring and Re-evaluation of Adverse Events of Medical Devices" are implemented.

European Union (IVDR): The requirements are extremely strict, forming another core aspect of the IVDR. Post-market surveillance plans (PMS Plans) and post-market performance follow-up plans (PMPF Plans) are mandatory. Serious adverse events, product recalls, safety corrective measures, and performance study results must be reported to the EUDAMED database. The Unique Device Identification (UDI) system is mandatory for the whole lifecycle traceability of products.