Key changes in MDCG 2020-16 rev.4

The revised guidance introduces: new classification scenarios for virological (e.g., SARS-CoV-2) and genetic tests, including those using molecular techniques, interpretation guidance for point-of-care tests (POCT), where classification may depend on user supervision, clarified criteria for self-testing devices, such as glucose meters, pregnancy tests, and diagnostic strips. The document also addresses the growing importance of IVD software, outlining how to classify it based on its function in the diagnostic decision-making process.

Companion diagnostics (CDx)

Special attention is given to companion diagnostics, i.e. IVDs used to support therapeutic decisions related to specific medicinal products. The updated guidance covers: requirements to demonstrate the link between the test and the drug, expectations for clinical evidence, recommendations for post-market performance monitoring.

Practical implications of the guidance

Although the guidance is not legally binding, it is widely adopted as a standard by notified bodies and competent authorities across the EU. It plays a critical role in: interpreting risk classification criteria, preparing technical documentation, ensuring compliance with IVDR. This update supports a harmonised interpretation of IVDR and helps facilitate consistent market access for IVDs throughout the EU. MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

Check information about EU Medical market ⚕️ MDR Regulator

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.

December 19, 2024

MDR Certification Process for Medical Devices: Key Insights from the Team-NB Consensus Document

The certification of medical devices under MDR is a multi-step process requiring thorough preparation and collaboration with Notified Bodies. Explore the key stages outlined in the Team-NB consensus document to streamline your certification journey.