In Vitro Diagnostic Medical Devices Regulation

The Role of Laboratories in the IVDR Process

A Changing World with the IVDR: A New Era Has Begun for Laboratories!

The IVDR (In Vitro Diagnostic Medical Devices Regulation - EU 2017/746) is an EU regulation that governs the safety, performance, and quality standards of in vitro diagnostic medical devices (IVD devices) within the European Union. It entered into force on May 26, 2017, and began to be implemented in phases starting May 26, 2022.

The European Union’s new regulation, IVDR (In Vitro Diagnostic Medical Devices Regulation - EU 2017/746), is ushering in a new era not only for manufacturers but also for testing laboratories. From diagnostic kits to software, and from sterile tubes to molecular tests, many products are now subject to much stricter performance and safety criteria.

So what does this new regulation mean for laboratory services?

Why Is the IVDR Important?

The IVDR is a mandatory regulation that replaces the previous IVDD directive, aiming to improve:

• Safety,

• Clinical performance,

• Transparency,

• And traceability

of in vitro diagnostic devices (IVD) on the European market.

With the IVDR, the following changes now apply:

• Product classification has been redefined (from Class A to D)

• CE certification processes are now subject to Notified Body oversight

• Clinical and analytical performance tests must be documented

• Products are registered in the EUDAMED system, and the UDI system is implemented.

The Role of Laboratories in the IVDR Process

Testing laboratories are an integral part of the certification process under the IVDR. Manufacturers must not only design their products but also verify their performance through independent and accredited laboratories.

This is where Nanolab Laboratory Services comes in.

Laboratory Services We Provide During the IVDR Compliance Process

1. Analytical Performance Tests

Limit of Detection (LOD) / Limit of Quantification (LOQ)
Linearity
Repeatability and accuracy
Matrix effect evaluations
Non-target interaction studies

2. Stability Tests

Monitoring chemical stability throughout the shelf life
Sensitivity to environmental factors such as heat, light, and humidity

3. Comparison with Reference Methods

Parallel testing with standard methods for clinical/analytical accuracy
Development and reporting of validation protocols

4. Sterility and Particle Tests

ISO 11737-compliant tests for sterile products
Particle and foreign matter analyses to reduce the risk of recall

5. Chemical Characterization and Residue Analyses

Chemical profile of reagents in contact with the device or consumables
Extract analyses in accordance with ISO 10993-18 and FDA guidelines

Who Needs These Services?

Diagnostic kit manufacturers (IVD)
Sterile consumable manufacturers (blood tubes, pipettes, strips, etc.)
Medical software developers
Medical device distributors
R&D or validation departments

Take Confident Steps Toward IVDR Compliance with Nanolab

Nanolab is here to support you with its competent infrastructure and expert analysts to evaluate your IVDR-covered products in accordance with European regulations and to support your documentation.

Comprehensive data generation for your certification process
International validity with accredited testing infrastructure
Protocol design, reporting, and consulting support

📞 Contact us for more information or to request a quote:

📧 [email protected] | 📍 Beylikdüzü / Istanbul

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