Certification for In Vitro Diagnostic Medical Devices under EU 2017/746

What are In Vitro Diagnostic medical devices?

In Vitro Diagnostic (IVD) medical devices are used to analyse samples taken from the human body to support diagnosis. Blood, urine, and saliva samples are examined in the laboratory, and the results feed diagnosis, monitoring, and treatment decisions. IVDs play an important role across many diseases.

Certification under EU Regulation 2017/746

EU Regulation 2017/746 (IVDR) sets the EU-wide standards for the placement and use of in vitro diagnostic medical devices. Certification against IVDR confirms the product's safety and performance. Sistem Patent Kalite provides a certification service that aligns with the regulation and supports manufacturers through the route.

How certification is obtained

Manufacturers that need IVDR certification contact Sistem Patent Kalite to open the process. The team provides the technical guidance and manages the certification workflow.

Which products the regulation covers

IVDR applies to reagents, kits, instruments, and systems used for in vitro examination of specimens derived from the human body. Classification is based on risk, and higher-risk classes require more extensive clinical evidence and post-market surveillance.

Advantages of the service

• Work led by specialists with IVD experience.
• A certification plan tailored to the specific product and its risk class.
• Efficient handling that keeps the file moving.
• Certification aligned with EU standards, supporting international market access.

Why IVDR certification matters

In vitro diagnostic devices support early diagnosis and effective treatment, which makes EU-aligned safety and performance evidence essential. Working with Sistem Patent Kalite gives the manufacturer a single partner for technical file preparation, conformity assessment, and the route to CE marking under IVDR.