IVDR In Vitro Diagnostic Device Certification Service

Core Content of New IVDR Requirements

• 01 CE Technical Documentation

  Adopt internationally recognized medical device nomenclature

  Comply with Annex II documentation requirements

  Include UDI related documents

  Complete risk management documentation

  Performance assessment and post-market performance follow-up (PMPF) documents

  Obtain Single Registration Number (SRN) after submitting Part A technical documents

• 02 UDI Technical Documentation

  Device Identifier (DI)

  Production Identifier (PI)

  UDI-DI shall be submitted to official system and Notified Bodies. UDI is mandatory for post-market surveillance and adverse incident handling. A unique registration number is required after UDI database registration. UDI-DI shall be marked on Free Sale Certificates (FSC) and EU Declarations of Conformity (DoC).

• 03 Enterprise Registration Documents

  Cover enterprise registration and official form filling, formulated in accordance with official database rules, similar to Part A of CE technical documents.

• 04 Quality Management System

  (a) Regulatory compliance strategy, including conformity assessment procedures and change management;

  (b) Identification of applicable general safety and performance requirements;

  (c) Management responsibility specification;

  (d) Resource management, including supplier and subcontractor control;

  (e) Risk management in accordance with Section 3 of Annex I;

  (f) Performance assessment including post-market performance follow-up as specified in Article 56 and Annex XIII;

  (g) Product realization planning covering design, R&D, production and after-sales service;

  (h) UDI assignment verification and information consistency control as required;

  (i) Establish and maintain post-market surveillance systems per Article 78;

  (j) Communication mechanism for competent authorities, notified bodies and relevant operators;

  (k) Reporting procedures for serious incidents and field safety corrective actions;

  (l) Corrective & preventive action management and effectiveness verification;

  (m) Product monitoring, data analysis and continuous improvement procedures.

• 05 Risk Management System

  Risk assessment covers technical update, field safety corrective action and clinical benefit evaluation.

  Lifecycle-based risk management system, updated in the first year after establishment and reviewed every two years thereafter to maintain continuous compliance.

• 06 Post-Market Surveillance System

  Post-market surveillance plan includes vigilance system, technical upgrade risk assessment, field safety notices, corrective actions, complaint collection, clinical risk control, PMPF, performance evaluation and non-compliance recall mechanism.

• 07 Ethical Review

  Class A and Class B devices are exempt from EU clinical performance evaluation; Class C and Class D devices require EU-based clinical performance assessment.

  Residual sample clinical evaluation is exempt from EU approval but requires ethical review, complying with the Declaration of Helsinki and ISO 14155 for clinical study design.

• 08 Performance Study Plan

  For Class C and D devices, performance testing based on Common Specifications in EU reference laboratories is a prerequisite for clinical research. Study plans shall be submitted to the EU database. Plan modifications require official approval. Study summaries and final reports must be submitted within three months after completion or suspension.

• 09 Clinical Evidence

  Including analytical & clinical performance evaluation, scientific literature data, cross-interference verification, PMPF and benefit-risk assessment.

• 10 Periodic Safety Update Report (PSUR)

  Manufacturers of Class C and Class D devices shall compile PSUR regularly.

  PSUR contents:

  (a) Conclusions of benefit-risk monitoring;

  (b) Key findings of post-market performance follow-up;

  (c) Sales volume, user group analysis and actual application frequency assessment.

  PSUR shall be updated at least annually for Class C & D devices and archived as part of Annex II & Annex III technical documents.

  Class C manufacturers shall submit PSUR to the assigned notified body and provide documents to competent authorities on request.

  Mandatory reporting for serious incidents, field safety corrective actions, periodic summary reports, trend reports and post-market surveillance documents.

• 11 Trend Reporting

  Mandatory reporting to competent authorities:

  (a) All serious incidents of EU-marketed devices, excluding predictable errors recorded in technical documents, which require trend analysis per Article 83;

  (b) Timely reporting of field safety measures and regular trend report submission schedules;

• 12 Post-Market Performance Follow-Up (PMPF)

  Refer to Annex XIII for performance evaluation, performance study and PMPF specifications.

  PMPF plan key items:

  (a) General principles for data collection including clinical feedback, literature review and performance data statistics;

  (b) Specific methods such as ring trial, epidemiological study and post-market clinical research;

  (c) Feasibility justification for selected evaluation methods;

  (d) Reference to performance evaluation reports and Annex I risk management requirements;

  (e) Clear objectives of PMPF activities;

  (f) Performance data comparison with equivalent devices and cutting-edge technical analysis;

  (g) Compliance with Common Specifications, harmonized standards and official PMPF guidelines;

  (h) Detailed schedule for PMPF data analysis and regular review.

• 13 Adverse Incident Reporting

  UDI is mandatory for reporting serious adverse events and field safety corrective actions.

  Unique identification numbers generated in clinical performance studies shall be used for incident reporting.

  Sponsors shall fully record during performance studies:

  (a) All adverse events affecting performance evaluation results;

  (b) All serious adverse incidents;

  (c) Device defects that may cause severe hazards without timely intervention.

• 14 CE Certificate Issuance Rules

  Class D devices require dual approval by Notified Body and EU competent authority with batch-by-batch certification.

  Class B and Class C devices are certified solely by Notified Bodies.

  Class D devices require performance verification by EU reference laboratories, covering analytical and safety performance with documented test plans.

  Class B & C verified by notified bodies; Class A verified by manufacturers internally.

  Class B technical document review complies with Annex IX 4.4-4.8, Annex I and Annex II, covering common specifications, harmonized standards, performance assessment, traceability, training, PMPF and risk vigilance. Unannounced quality system audits are strengthened.

  Trend reports are mandatory for Class B and Class C certification.

  All CE certificates shall be filed in the official certificate database.

  Valid CE certification is a prerequisite for EU market access and FSC application.

• 15 Free Sale Certificate (FSC)

  FSC shall indicate the basic UDI-DI of devices and unique identification numbers issued by notified bodies. The member state where manufacturers or authorized representatives are registered shall issue FSC upon application.

• 16 Classification Rules

  Refer to Annex VIII