Yahoo! JAPAN

2022/4/27 -Clinical benefit is a new term under the IVDR and means to provide an accurate result which supports appropriate patient management decisions ...

The IVR codes may specify a field of in vitro diagnostic medical application (e.g. IVR 0401 Devices intended to be used in screening/confirmation of congenital/ ...

2023/3/23 -The In Vitro Diagnostic Regulation (IVDR) is a European Union regulation applicable to in vitro diagnostic medical devices.

Critical content for compliance with the In Vitro Diagnostics Regulation (IVDR). A Summary of Technical Documentation (STED) file is a detailed description ...

2020/1/23 -Intended purpose is key because it is a key input into the design of a device, risk management, performance evaluation and classification.

2020/3/24 -The Technical Documentation submission guidance is aligned to the requirements of the IVDR, described in detail in Annex II and III. Notified ...

FAQs - IVDR Transitional provisions. When does the IVDR apply? The in vitro diagnostic medical devices Regulation (EU) 2017/746. (IVDR) will apply from 26 May ...

The IVDR is the current regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the ...

2023/12/14 -This article talks about an overview of assigning IVDR codes in conformity assessment applications to ensure safety and compliance market ...

2022/8/1 -... IVDR regulates when manufacturers do not have to provide the IFU in paper format: “When the device is intended for professional use only ...