IVDR Certification Process – Team-NB Consensus on Conformity Assessment

Team-NB has released a consensus paper outlining the certification process for in vitro diagnostic medical devices (IVDs) under the IVDR. The document presents a harmonised approach among notified bodies for technical documentation review and lifecycle management of certificates. Its objective is to improve clarity, predictability, and efficiency of the process for manufacturers. These guidelines aim to reduce deficiencies and streamline communication with notified bodies.

Stages of the IVDR conformity assessment cycle

The guidance structures the certification pathway into clearly defined phases.

• Application submission – including the full technical documentation, QMS information, and post-market surveillance planning,
• Formal review – assessment of completeness and eligibility, assignment of the review team,
• Technical review – evaluation of clinical evidence, PMPF data, PMS plans, and compliance with GSPRs (Annex I),
• Queries and clarifications – interactive rounds of questions and responses between the notified body and manufacturer,
• Final decision and certificate issuance – upon satisfactory resolution of all requirements,
• Surveillance and recertification – conducted annually according to the chosen conformity assessment route (e.g., Annex IX, XI).

Key recommendations from Team-NB to improve the certification

Team-NB emphasises that the efficiency of the certification depends on preparation, documentation quality, and communication. Recommendations include:

• Clear dossier structure – strictly aligned with Annex II and III, ensuring logical traceability between risk, evidence, and post-market planning,
• Early preventive actions – conduct a gap analysis to identify potential deficiencies before submission,
• Dedicated communication channels – designate formal contacts and align expectations on response formats and timelines,
• Adaptation to procedure type – tailor documentation to the specific conformity route (e.g., full QMS vs. technical file review).

Summary

The Team-NB consensus contributes to harmonising expectations and practices among notified bodies, helping reduce divergence in interpretations. It enhances transparency for manufacturers—especially SMEs and first-time applicants—and facilitates smoother certification under IVDR. The guidance supports both compliance and business continuity in a complex regulatory environment.

Read the article: Team-NB IVDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document