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).

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

Check information about EU Medical market ⚕️ MDR Regulator

Medical professional holding rapid diagnostic test cassette with positive result

April 18, 2025

IVDR Certification Process – Team-NB Consensus on Conformity Assessment

The “IVDR Certification Process – Consensus Document” was developed by Team-NB to provide a unified set of good practices for conformity assessment under IVDR. It reflects not only the regulatory framework but also operational insights gained from notified body assessments during the first years of IVDR implementation. While not legally binding, the document serves as a valuable reference for manufacturers preparing for certification.

March 27, 2025

MDCG Updates Guidance on IVD Classification under IVDR

The Medical Device Coordination Group (MDCG) has published an updated version of its guidance MDCG 2020-16 rev.4, concerning the classification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR). The revision aims to clarify classification rules in light of emerging technologies and the evolving diagnostic landscape. It includes new examples, refined terminology, and practical advice to support both manufacturers and notified bodies in assigning the appropriate risk class to IVDs.

March 20, 2025

Certificates with Conditions – Team-NB proposal under MDR and IVDR

The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) provide the possibility to issue certificates with conditions, limitations, or restrictions. This regulatory flexibility can facilitate market access for innovative and breakthrough medical technologies that may not yet have a complete clinical evidence base. Team-NB, the European Association of Notified Bodies, has published a position paper promoting the wider use of this tool.

February 27, 2025

MDR Regulator at MedTech Summit in Budapest!

Last week, for the second consecutive year, we participated in the MedTech Summit in Budapest – one of the key industry events dedicated to medical device regulations. Our CEO, Katarzyna Wesołowska, shared her expert insights during the discussion panel “Consultants' Experiences in Transitioning from MDR to IVDR.”

February 24, 2025

Registration of Specific Medical Devices in the United Kingdom

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated the registration requirements for Class I medical devices and those with expired CE certificates. The new regulations aim to improve oversight of medical device safety and compliance with UK regulations.

February 22, 2025

New Version of MDCG 2019-6 Rev.5 Document on Notified Body Requirements

The Medical Device Coordination Group (MDCG) has published a new version of the MDCG 2019-6 Rev.5 document, which includes updates on the organization, operation, and obligations of notified bodies in the conformity assessment process.

January 30, 2025

MHRA: IMDRF’s Latest Guidance on AI and Medical Device Software

On January, 2024, the IMDRF published guidance on Good Machine Learning Practice (GMLP) for Medical Devices and considerations for medical device software & software-specific risk. These documents provide a framework for ensuring best practices in AI-based medical devices and systematic risk assessment for medical software.

January 17, 2025

MHRA Guidance on New Medical Devices: Post-Market Surveillance Requirements

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance on post-market surveillance (PMS) requirements for medical devices. These new regulations are critical for manufacturers, distributors, and healthcare professionals to ensure the continued safety and effectiveness of medical devices in the UK.

December 27, 2024

A year of breakthroughs in medical devices and in vitro diagnostics: Summary of 2024 year

The year 2024 has been a time of intensive changes and challenges for the medical device and in vitro diagnostics (IVD) industries. As active participants in these sectors, we had the opportunity to witness and contribute to key events that shaped the future of the market and regulatory standards.