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IVDR Regulation Process
The new European Union IVDR regulation described in Article 10(4), Technical File, is a mandatory requirement for all manufacturers applying for IVDR CE certification with any notified body.
The IVDR replaced the IVDD and entered into force on May 26, 2017, with an implementation due date of May 26, 2022. All new in vitro diagnostic devices placed on the EU market, including class A non-sterile devices, must follow the new IVDR regulation. The major changes are as below:
- IVD classification based on Rule
- Requirements for clinical evidence and post-market performance follow-up
- Increased traceability of devices (UDI)
IVDR Transition Timeline
In-Vitro Diagnostic Device Confirmation as per IVDR
According to EU IVDR 2017/746, an in vitrodiagnosticl medical device is any medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software, or system.
Whether used alone or in combination, it is 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 mainly for the purpose of providing information on one or more of the following:
- regarding a physiological or pathological process or state;
- regarding congenital physical or mental impairments;
- regarding the predisposition to a medical condition or a disease;
- to establish the safety and compatibility with potential recipients;
- to forecast treatment response or reactions;
- to define or monitoring therapeutic measures.
CLASS A
To be added
CLASS B
To be added
CLASS C
To be added
CLASS D
To be added