The European In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 remains the top priority for the medical devices industry. While recent legislative updates (Regulation 2024/1860) have pushed the final date for placing on the market or putting into service legacy Class C devices to December 31, 2028 (subject to certain requirements), manufacturers must not be lulled into a false sense of security.
There is often confusion between the application deadline and the transition deadline. Under the new rules, legacy Class C devices can stay on the market until December 31, 2028 only if the manufacturer takes active steps toward IVDR certification now. Therefore, the transition deadline is conditional and you must hit a critical milestone by May 26, 2026 to qualify for that extra time.
To keep your Class C device on the market, you must meet these specific checkpoints:
- As of May 26, 2025: you must have an IVDR-compliant Quality Management System (QMS) in place
- By May 26, 2026: you must lodge a formal application for conformity assessment with a Notified Body, such as SGS
- By September 26, 2026: you must have a signed formal agreement (contract) with that Notified Body
- By December 31, 2028: transition must be complete. The Directive-compliant device must be replaced with an IVDR-compliant device
If you miss the May 2026 application window you will not benefit from the extended transition provisions. This means you could be forced to pull your product from the market until a full IVDR certificate is granted, a process that currently takes 18–24 months on average.
How we support your transition
As a leading Notified Body (NB 1639), we understand the pressure of these staggered deadlines. We offer a streamlined pathway to help you secure your market position well before the capacity crunch hits.
Our IVDR services include:
- Certification through conformity assessment: expert auditing and technical file review for IVD devices, including Class B and Class C devices, to ensure legal market access
- Quality management system (QMS) certification: auditing your QMS, such as in ISO 13485 (medical devices) QMS, to ensure it meets IVDR Article 10(8) requirements
- Training: providing essential learning paths, including EU IVDR introduction training, technical document training and ISO 13485 internal auditor/lead auditor training
Act now to secure your slot
With approximately 80% of IVDs requiring Notified Body involvement for the first time, capacity is the industry's biggest bottleneck. Backed by a global network of specialized experts and laboratories, we understand the hustle of medical devices regulatory compliance and the nuances of the EU market. Lodging your application with us today ensures you won’t be left waiting.
For further information, please contact:
Eric Chow
Global Marketing Manager
Business Assurance
t: +44 (0) 127 669 7722
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of over 100,000 dedicated professionals. With more than 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and a portfolio of trusted specialized brands, including Applied Technical Services, Brightsight, Bluesign and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN SW).
