/ Analytical Performance Evaluation Laboratory

Ensuring the safety and validity of in vitro diagnostic devices

Laboratoire IVDR - ISO 17025

+25 years experience


First laboratory in France accredited ISO/IEC 17025:2017
for IVD evaluation.

We offer the best guarantees of compliance with the requirements of the new EU regulation 2017/746 on in vitro diagnostic devices, the IVDR.

/ Our customers in the European DM-IVD market


We provide you with a complete and rigorous analysis for the validation of your equipment.


We help you provide recommendations and open perspectives.

Start-up ecosystem

We provide you with essential performance assessments for technology development and validation.

/The services of our laboratory for evaluating the analytical performance of in vitro diagnostic medical devices

Performance testing and technical characteristics of the automata and reagents in vitro diagnostics in accordance with IVDR

Continuous monitoring of IVD performance evaluation and updating of PER via the PMPF

Advice and support: analysis parameters and IVDR

Measurements carried out on biological reagents

Evaluation of automatons
and reactive/automatic couples

Would you like to request a quote or discuss your analysis program?

/ Why entrust us with performance evaluation?

Accelerate your devices go to market

Our expertise will enable you to quickly obtain reliable and accurate data.

Build customized regulatory files with the help of our team

The services are specific to your devices. Our team masters the nuts and bolts of regulatory compliance to enable you to create tailor-made regulatory files.

Meet the three requirements required by IVDR and DIN EN ISO 13485-2016

They will guarantee that you can meet the 3 requirements required by the IVDR and the DIN EN ISO 13485-2016 standard, for your device, for the use for which it is intended.

/ New CE IVDR regulation 2017/746: what changes

The implementation of European Regulation EU 2017/746 (IVDR) has modified the responsibilities of professionals in this sector with regard to the analytical performance evidence provided to notified bodies.

All manufacturers and distributors of in vitro diagnostic devices in the EU are therefore obliged to comply with the new IVDR requirements. The percentage of devices requiring the intervention of a notified body has exploded, from 7% to 80%!

To carry out this type of analysis, trusted third parties may be commissioned. For European reference laboratories, this activity can only be carried out by ISO/IEC 17025 accredited structures specialized in the field, such as ours.

The IVDR has also redefined the classes of in vitro diagnostic devices: class A, B, C or D. They are prioritized according to the level of risk for patients and public health (from low to high). The frequency of PER updates will depend on the DIV class. Class A and B devices can be updated as needed, but class C and D devices will be updated at least once a year.

Other changes have been introduced, including higher requirements on pharmacovigilance, transparency, etc.

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What are the regulations for medical devices?

In the EU, medical devices (MD) are regulated by the MDR (EU Regulation 2017/745), which came into force on May 26, 2021. In vitro diagnostic medical devices (IVD MD) are regulated by the IVDR (EU Regulation 2017/746) which entered into force on May 22, 2022. Any new medical or in vitro diagnostic device must comply with the regulations for its European market authorization. In addition to pre-market notification or approval procedures, products are subject to regular inspections and audits. They must also be monitored throughout their life cycle.

What are the conditions for placing medical devices on the market?

The placing on the European market of any medical device (MD) or in vitro diagnostic medical device (IVD) requires CE marking on the product. This certifies regulatory compliance, in terms of performance and safety for patients and users. Manufacturers must follow a conformity assessment process which, depending on the risk class of the device, may require the intervention of a notified body to assess the technical documentation and quality systems.

Manufacturers of IVDMDs must ensure high levels of safety and performance, based on clinical evidence. These are proven by 3 types of data from:

  • scientific validity;
  • analytical performance evaluation;
  • clinical performance evaluation.

A performance evaluation plan should describe the method used to obtain the data and also indicate planning for performance monitoring after the device is placed on the market.

How to evaluate the performance of in vitro diagnostic medical devices?
Analytical performance evaluation is part of the overall performance evaluation of an in vitro diagnostic device. It must demonstrate the ability of the device to detect or measure the analyte (the substance to be analyzed), in accordance with IVDR requirements, in terms of:
  • precision ;
  • sensitivity;
  • specificity;
  • exactness ;
  • linearity.
The necessary tests vary depending on the technology and the intended application of the device.
Why have analytical performance evaluated by a trusted third party?

Evaluation of the analytical performance of medical diagnostic devices by a trusted third party has several significant advantages:

  • Better guarantee of regulatory compliance.
  • Objectivity and impartiality.
    Increased credibility.
  • Specific expertise in evaluating the performance of  IVD MD.
  • Acceleration of the regulatory approval process and marketing.
  • Benefits of an external perspective which can reveal areas for improvement not identified internally.
How to evaluate the clinical performance of in vitro diagnostic medical devices?

Clinical performance evaluation is one of the three pillars of evaluating the performance of an in vitro diagnostic device. Indeed, it adds to the demonstration of scientific validity and the evaluation of analytical performance.

If the device is innovative, the data can be based on a demonstration of equivalence with an existing IVD. This approach requires a very rigorous analysis to establish a solid equivalence, in terms of technology used, performance, and clinical use.

A specific study of clinical performance is necessary if data are insufficient, particularly for class D devices which present the highest level of risk.

In summary, clinical performance can be demonstrated via:

  • clinical performance studies;
  • the study of the state of the art (peer-reviewed literature);
  • published routine diagnostic tests.

The new regulatory requirements of the IVDR, both in terms of documentation and reporting and performance evaluation, involve additional resources and also lead to administrative overloads.

What is a reference laboratory in IVDR?
Reference laboratories are among the new players introduced by the IVDR. Their role is to provide scientific and technical assistance to the various IVD MD stakeholders:
  • European Commission
  • Member States
  • Notified Bodies
  • Manufacturers
They can be involved in different stages of the evaluation of in vitro diagnostic medical devices according to the IVDR:
  • Verification of the declaration of conformity of class D devices
  • Device performance
  • Development of standards and guidelines for performance testing and evaluation.
Implementing Regulation (EU) 2023/2713 which designates the European Union Reference Laboratories (EURL) for IVDs will enter into force on October 1, 2024.The list of reference laboratories is annexed to the Regulation.
Why an ISO 17025 laboratory rather than ISO 15189?

According to Article 8 of Implementing Regulation (EU) 2022/944, performance assessment laboratories should be ISO17025 accredited to comply with the competence requirements. Indeed, it is no longer a question of the skill of use to render a medical analysis, but rather of work on the metrology of measurement and evaluation of the measurement tool.

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