IVD (In Vitro Diagnostic) Medical Device Tests

The In Vitro Diagnostic Medical Devices Regulation, published in the European Union countries, will be implemented gradually as of May 2022. In the current pandemic process, a vital need has arisen for accurate diagnosis and a flexible regulatory framework for in vitro medical devices. The in vitro diagnostic medical devices regulation has guidelines to ensure that important medical devices, such as COVID or HIV tests, continue to be available and safe.

According to the legislation in question, new requirements for higher risk devices such as HIV or hepatitis tests (risk class D) will apply from May 2025. For lower risk devices, such as some influenza tests (risk class C), the application date has been extended to May 2026. For lower risk class devices (risk class B and A), implementation will start in May 2027.

In the new implementation, conformity assessment bodies (notified bodies) are given a more important role. Namely, these organizations will independently inspect whether the devices comply with the safety and performance requirements before they reach the European Union market.

In vitro diagnostic medical devices are tests used on biological samples to detect a person's health status. A wide variety of in vitro diagnostic devices (IVDs) are used, from self-tests for pregnancy and blood glucose tests for diabetics to complex tests performed in clinical laboratories.

The said in vitro diagnostic medical device regulation aims to ensure a high level of public health and patient safety and to be trouble-free, taking into account scientific progress.

The regulation includes four risk classes:

• Class A, low individual risk or low public health risk
• Class B, moderate individual risk or low public health risk
• Class C, high individual risk or moderate public health risk
• Class D, high individual risk or high public health risk

Our organization also provides IVD (in vitro diagnostic) medical device testing services with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.