IVDR Compliance Services for In Vitro Diagnostic Devices
Navigate the European IVDR requirements with confidence. From regulatory assessments and technical documentation reviews to Authorised Representative services and ongoing compliance support, Obelis helps menufacturers maintain access to the EU market.Â
Obelis Group
Boulevard Brand Whitlock 30,Â
Brussels, 1200, Belgium
Tel: +32 (0)2 732 59 54
hello@obelis.net
© Obelis Group 2026
Frequently Asked Questions
Does the 26 May 2026 deadline apply to all legacy IVDs?Â
No, this deadline specifically applies to legacy devices that did not require CE certificate under IVDD and that will become IVDR class C device.Â
What happens if I don't apply to a Notified Body by 26 May 2026?
Your device may no longer be legally placed on the EU market. Formal application to Notified Body before 26 May 2026 is legal condition to enjoy the extended transition period and continue placing the device on the market.Â
When must my IVDs, upclassified to IVDR class C, be fully IVDR compliant?
By 31 December 2028, IVDs upclassified to IVDR class C must complete the transition and fully met IVDR requirements, ensuring they can continue to be lawfully placed and made available on the EU market.Â
Can Obelis Group support my legacy device transition?
Obelis provides IVDR transition support tailored to IVDs upclassified to IVDR class C. Our team assists manufacturer with every stage of the process, from upgrading and aligning QMS with IVDR requirements to preparing and submitting a complete application package to the Notified Body. As your Authorised Representative, we guide you throughout the entire transition period.Â
IVDR Specialists
End-to-End Support
Global Regulatory Partner
What's Next Under IVDR?
The In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746) sets the regulatory framework for IVD devices in the EU.Â
It introduces stricter requirements for clinical evidence, performance evaluation, risk classification, PMS and vigilance to enhance patient safety and ensure high-quality diagnostics. Manufacturers whould prepare for upcoming IVDR legacy deadlines, including 26 May 2026 for Class C devices and 26 May 2027 for Class B and Class A sterile devices to ensure continued compliance.Â
Stronger clinical evidence
Risk-based classification (A-D)
Enhanced transparency
Ongoing PMS and Vigilance
Better patient safety
Who Must Comply with IVDR?
Manufacturers
Non-EU Manufacturers
Importers
Distributors
Place and market IVD devices in the EU
Need an EU Authorised Representative
Responsible for market entry obligations
Must verify compliance before distribution
Why Manufacturers Need IVDR Support?
Device classification and rules
Performance evaluation requirements
Technical documentation updates
PMS & vigilance obligations
Notified Body interaction
Legacy device transition
Regulatory strategy planning
Obelis IVDR Compliance Services
EU Authorised Representative
IVD Gap Assessment
Technical Documentation Review
Label & UFI Review
PMS & Vigilance Support
Notified Body Selection
Regulatory Consulting
EUDAMED Registration
Ongoing Compliance
Get our free supporting tools
Download it now:
Client Success Stories
The EUDAMED verification and mandate update were completed successfully, allowing us to maintain our device on the EU market without any regulatory issues or interruptions. The process was efficient and well managed.Â
We successfully maintained our EU market access
Biobeat Technologies Ltd.Â
The notification process was completed smoothly and efficiently. Thanks to the clear guidance and detailed communication, we were confident that all requirements were met and that the submission was properly aligned with EU expectations.
We achieved a fully compliant submission throughout a well-managed process
Bogenebiotech Co., Ltd.
Thanks to our consultant's expert support, the EU/IVDR review and EUDAMED registration were completed successfullt, and our biochemistry analyser is not fully compliant and placed on the EU market. The process was seamless, and we had full confidence at every step.
Their expert support gave us confidence at every step of the compliance process
Athenese-Dx Pvt.Ltd