EUROPEAN IN VITRO DIAGNOSTIC MEDICAL DEVICES REGULATION

 

IN VITRO DIAGNOSTIC MEDICAL DEVICE REGULATION

Medical devices have a vital role in providing better diagnosis, prevention, Screening, monitoring, and treatment of various diseases. The COVID -19 pandemic challenge has shown the necessity to have accurate diagnostics and a stringent framework for the in vitro medical devices (IVDs). IVDs are biological tests that can detect disease, condition and infections. In vitro means glass that means the tests are usually conducted in glass test tubes. The examples of IVDs include Pregnancy test device, Glucometer kits to monitor blood sugar, HIV test kit, COVID 19, and many more. 

EUROPEAN IN VITRO DIAGNOSTIC MEDICAL DEVICE REGULATION (EU IVDR): AN OVERVIEW  

 The EU lawmakers did not change any requirements of the In vitro Diagnostic Regulation (IVDR) but only changed the transitional provisions to allow the Regulation’s gradual application.EU updated the rules with a purpose to improve the safety of IVDs. The duration of transition periods depends on the type of device. For example, the transition period for higher risk devices that is class D such as HIV or Hepatitis and few Class C devices such as influenza is until May 2025 and 2026, while lower risk devices belonging to Class A and B   have transition periods till May 2027. 

Read More – IVDR Technical Documentation

CLASSIFICATION OF DIAGNOSTIC DEVICES UNDER IVDRs. 

According to IVD Regulation (EU) 2017/746, medical devices are classified as classes A, B, C and D, based on the intended purpose of the devices and risks associated. 

Read More – IVDR Classification – CE marking

The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) has laid down a new regulatory framework for in vitro diagnostic medical devices.  The examples include HIV tests, pregnancy tests or SARS-CoV-2 tests. There is an increase in the involvement of independent notified bodies. Manufacturers will have to adapt quality management systems for their devices so as to apply to a notified body well in advance before the transition periods.  

Read More - IN VITRO DIAGNOSTIC MEDICAL DEVICE REGULATION

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