Understanding Common Specifications for In Vitro Diagnostic Medical Devices in the EU

What are Common Specifications?
Common Specifications are essentially a set of technical and/or clinical requirements designed to ensure that a particular IVD medical device, process, or system meets the legal obligations necessary for patient safety and effectiveness. They act as a benchmark or guideline for manufacturers, providing clear directions on the minimum requirements their products should meet.

In an ideal scenario, every IVD medical device or process would have a harmonized standard, which is an internationally recognized set of criteria that a product, service, or process can be measured against. However, due to the dynamic nature of the medical tech industry, not all products or processes have such a standard. Even if they do, sometimes these standards may not adequately address all the requirements.

In such instances, Common Specifications come into play, filling the gaps where harmonized standards might be missing or insufficient.

EU Commission and Class D IVDs
The EU Commission, recognizing the significance of these IVD medical devices, has recently adopted new Common Specifications for several types of Class D IVDs. Class D IVD medical devices are considered high-risk, and ensuring their safety and effectiveness is crucial. These new CS bring more clarity and detail to manufacturers about what is expected of their products, particularly in areas like:

Minimum Performance Characteristics:This relates to the efficiency and accuracy of the IVD. For instance, how sensitive is the device? How specific is it to the condition it’s diagnosing?

Number of Tests Per Method: This specification gives clarity on the volume of tests an IVD medical device should be able to handle based on the manufacturer’s claims.

Qualification Criteria: What criteria should be met for an IVD medical device or system to be deemed suitable for use? This might include standards for equipment, procedures, or personnel.

Acceptance Criteria: This details the standards that a test result must meet to be considered acceptable. It ensures consistency and reliability in the results produced by the IVD.

The Road Ahead
The adoption of these  Common Specifications by the EU Commission is a significant step forward in ensuring that IVDs, especially those of Class D, are reliable, safe, and effective. For manufacturers, these CS provide a clear pathway to ensure their products meet the necessary requirements. For medical professionals and patients, it gives added confidence in the devices that play a critical role in diagnosis and treatment.

In July 2022 Regulation (EU) 2022/1107 was published, Common Specifications – IVDR | QRcompliance, in which common specifications for the following Class D IVDs are laid down:

Devices intended for detection of blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems.
Devices intended for detection or quantification of markers of human immunodeficiency virus (HIV) infection.
Devices intended for detection or quantification of markers of human T-cell lymphotropic virus (HTLV) infection.
Devices intended for detection or quantification of markers of hepatitis C virus (HCV) infection.
Devices intended for detection or quantification of markers of hepatitis B virus (HBV) infection.
Devices intended for detection or quantification of markers of hepatitis D virus (HDV) infection.
Devices intended for detection of markers of variant Creutzfeldt-Jakob disease (vCJD).
Devices intended for detection or quantification of markers of cytomegalovirus (CMV) infection.
Devices intended for detection or quantification of markers of Epstein-Barr virus infection (EBV).
Devices intended for detection of markers of Treponema pallidum infection.
Devices intended for detection or quantification of markers of Trypanosoma cruzi infection.
Devices intended for detection or quantification of markers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

If you’re finding the IVDR tough to navigate, don’t worry – QRcompliance is here to help. Visit our website at www.qrcompliance.nl. We also provide a selection of templates in our online shop to assist you in setting up compliant documentation seamlessly. Let QRcompliance guide you through the intricacies of the IVDR.

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