Webinar - 2026 EU IVDR Regulatory Updates and Key Considerations for Certification Applications
Explore the practical implications of Regulation (EU) 2026/977, proposed changes to the IVDR, and key considerations to help manufacturers prepare stronger certification applications and avoid unnecessary delays.
The EU regulatory landscape for in vitro diagnostic medical devices (IVDs) continues to evolve in 2026. Commission Implementing Regulation (EU) 2026/977, published in May 2026 and applicable from 25 February 2027, introduces harmonized requirements relating to Notified Body quotations, conformity assessment timelines and recertification procedures, with direct implications for the information manufacturers need to provide during the application process.
In parallel, the proposed revision of the MDR and IVDR, COM(2025) 1023, published on 16 December 2025, is currently under consideration by the European Parliament and the Council. If adopted, the proposal is expected to introduce significant changes affecting future certification practices.
With the EUDAMED registration deadline of 28 November 2026 also approaching, it is increasingly important for manufacturers preparing to enter the European market or currently pursuing IVDR certification to understand these developments and prepare accordingly.
Jointly hosted by DNV and the Korea In Vitro Diagnostic Medical Devices Association (KIVDA), this webinar will explore the key provisions of Commission Implementing Regulation (EU) 2026/977 and the main IVDR-related changes proposed under COM(2025) 1023. The session will also address common causes of delays during certification applications, key information and requirements expected by Notified Bodies, and practical considerations to support a smoother and more efficient IVDR certification process.
Webinar details
- Date: Monday, 2 November 2026
- Time: 2:00–3:00 PM KST
- Language: Korean
- Hosted by: Korea In Vitro Diagnostic Medical Devices Association (KIVDA) & DNV
- Speakers: Yeoni Woo, IVDR Auditor; Sunghwa Bae, IVDR Auditor
Who should attend?
This webinar is designed for RA/QA professionals, certification and regulatory affairs teams, product development professionals, and international business teams at IVD manufacturers preparing for EU market access or IVDR certification.
It will be particularly relevant for those seeking to understand the latest IVDR regulatory developments and potential future changes, as well as the preparation required to minimize delays during the certification application process and better understand key Notified Body requirements.
Stay informed about the latest IVDR regulatory developments and gain practical insights to support a more effective certification application and preparation process.
※ Please note: COM(2025) 1023 is currently under consideration by the European Parliament and the Council, and its provisions may change during the legislative process. This webinar is intended for regulatory information sharing purposes and does not constitute consulting or advice for individual products.