The transition from IVDD to IVDR introduces significant regulatory requirements for manufacturers of in vitro diagnostic (IVD) devices. Particularly affected are legacy devices, which did not require the involvement of a Notified Body for CE marking under IVDD, and which are now classified as class C devices under IVDR.
With the IVDR deadlines in 2026 approaching, manufacturers must act now and submit their application for IVDR certification to a Notified Body in due time. This is essential to ensure continued market access within the EU.
What does the transition from IVDD to IVDR mean for class C devices?
Under IVDR (EU) 2017/746, significantly stricter requirements apply regarding safety, performance evaluation, and clinical evidence. Products that previously did not require certification must now obtain CE marking with the involvement of a Notified Body.
For manufacturers of IVDR class C IVDs, this includes:
- Conducting a conformity assessment procedure with a Notified Body
- Preparing an IVDR-compliant quality management system
- Preparation of technical documentation
- Demonstration of performance and safety
IVDR deadlines for class C in 2026
Meeting the regulatory deadlines is critical for maintaining market access:
- 26 May 2026: Submission of the application to a Notified Body for IVDR certification
- 26 September 2026: The certification contract between the Notified Body and the manufacturer must be signed
The formal and successful IVDR application is a legal requirement and a prerequisite for placing products on the EU market.
Role of the Notified Body in the IVDR certification process
For class C devices, cooperation with a Notified Body is mandatory. The Notified Body evaluates, among others:
- Technical documentation, including performance evaluation of IVD devices
- Quality management system for manufacturing and management of IVD devices
- Clinical and analytical performance data
We offer the certification service under IVDR with our Notified Body SGS Fimko Oy with direct contacts and auditors located in Germany. You are welcome to contact us for further information.
Your benefits with SGS
With SGS as your partner, you benefit from:
- Direct access to a Notified Body (CE 0598)
- Local contacts and auditors in Germany
- Efficient communication and streamlined processes
- High planning reliability throughout the certification process
- Extensive experience in IVD and IVDR compliance
Further information about the IVDR designation scope of SGS Fimko Oy can be found here. We also provide FINAS accredited ISO 13485 certification (S009_M38_2026.pdf) to be accompanied with IVDR certification.
Contact
Vasily Kalakutskiy
t: +49 89 78 74 75-137
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Customer Service Team
t: +49 89 78 74 75-222
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