In Vitro Diagnostic Medical Device Regulation

 

IVDR stands for In Vitro Diagnostic Regulation.

IVDR is a risk-based approach to classify device with increased notified body and competent authority controls. The Regulation identifies four risk classes:

·       Class A (lowest risk),

·       Class B,

·       Class C, and

·       Class D (highest risk)

 

while Annex VIII define seven classification rules to correctly classify the products.

 

Regulatory Authority:

IVDs are devices as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act, and may also be biological products subject to section 351 of the Public Health Service Act. Like other medical devices, IVDs are subject to premarket and postmarket controls.

CE Marking is required for all in vitro diagnostic (IVD) devices sold in Europe. CE Marking indicates that an IVD device complies with the European In-Vitro Diagnostic Devices Directive (IVDD 98/79/EC) and that the device may be legally commercialized in the EU.

The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) establishes a new regulatory framework for in vitro diagnostic medical devices, such as HIV tests, pregnancy tests or SARS-CoV-2 tests. It is estimated that around 70% of clinical decisions are made using in vitro diagnostic medical devices.

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