Arazy Group: IVD Device Regulation in EU

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How to Get CE Mark of an IVD Device

In order to get CE mark, you need to comply with one or more of the following requirements:

Establish and maintain a Medical Quality Management System (QMS)
Test your product in order to demonstrate compliance with applicable standards.
Prepare a Technical File / Design Dossier for each family of products that you wish to obtain CE mark for.
Contract a European Authorized Representative.
Contract a Notified Body who will audit your Quality Management System and Technical Files / Design Dossiers.
Register your company and list your product with at least one European Competent Authority.

The actual requirements for you family of products are subjected to the classification of your devices. This classification is based on the level of risk your device contains.

Here are some examples of devices relating to product classification.

Description	CE Classification
Automated Tissue Resistance Measuring System	General
Automatic Cell Counter	General
Centrifugues	General
Cholesterol Test	Self-diagnostic
Chromatograph	General
Gas blood Analyzer	General
Haematology Analizar	General
Ion Blood Analyzer	General
Male Fertility Test	Self-diagnostic
Menopause Test	Self-diagnostic
Osmometer	General
Ovulation Predictor Test	Self-diagnostic
pH-meter	General
Pregnancy Test	Self-diagnostic
Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell,	List A
Reagents and reagent products, including related calibrators and control materials, for the detection, confirmation and quantification in human specimens of markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D.	List A
Reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies.	List B
Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: anti-Duffy and anti-Kidd.	List B
Reagents and reagent products, including related calibrators and control materials, for determining the following HLA tissue groups: DR, A, B,	List B
Reagents and reagent products, including related calibrators and control materials, for determining the following human infections: cytomegalovirus, chlamydia,	List B
Reagents and reagent products, including related calibrators and control materials, for determining the following tumoral marker: PSA,	List B
Reagents and reagent products, including related calibrators and control materials, for diagnosing the following hereditary disease: phenylketonuria,	List B
Reagents and reagent products, including related calibrators and control materials, for the detection and quantification in human samples of the following congenital infections: rubella, toxoplasmosis.	List B
Reagents and reagent products, including related calibrators, control materials and software, designed specifically for evaluating the risk of trisomy 21,	List B
The following device for self-diagnosis, including its related calibrators and control materials: device for the measurement of blood sugar.	List B
Urine Qualitative Dipstick Bilirubin	Self-diagnostic
Urine Qualitative Dipstick pH	Self-diagnostic
Vaginal Acidity Test	Self-diagnostic
Vis / UV-Vis Spectrophotometer	General

If any of these examples is equal or similar to your type of products, take note of its classification and click on the corresponding blue button. If you are not sure, click on the Tell us what you need button and let us do the work for you.