In Vitro Diagnostic Regulation [ IVDR 2017/746)

Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

• Concerning a physiological or pathological state, or
• Concerning a congenital abnormality, or
• To determine the safety and compatibility with potential recipients, or
• To monitor therapeutic measures.

General laboratory products are not in vitro diagnostic medical devices unless the manufacturer claims to be used for in vitro diagnostic examination.

For in vitro diagnostics there is no classification as per MDD (93/42/EEC). However, there is a categorization as follows,

• Devices according to Annex II, List A
• Devices according to Annex II, List B
• Devices for self testing
• Devices for performance evaluation
• All other in-vitro diagnostics

Depending on the category the manufacturer has to carry out a suitable conformity assessment, as stipulated in Article 9 of the IVDD, according to the relevant Annexes III, IV, V, VI or VII.

Few examples for such type of devices are the following:

• Automatic Cell Counter - General
• Cholesterol Test - Self-Testing
• 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-erythrocyte antibodies.  -  List B

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