DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training ...

This was conducted between April and May 2023, eliciting responses from all 39 notified bodies designated under the Medical Devices Regulation (MDR) and 10 Notified bodies designated under the In ...

Previously governed by the IVDD (Directive 98/79/EC), the IVDR (Regulation (EU) 2017/746 on in-vitro diagnostics) took effect on May 26, 2022, after a five-year transition period, requiring ...

What Is IVDR 2017/746? IVDR 2017/746 is the European Union's regulation governing in vitro diagnostic medical devices. Effective from May 26, 2022, with transitional provisions extending to May ...

has been recognized by the European Commission as a notified body for the certification of devices under the European Union's In Vitro Diagnostic Regulation (IVDR). The designation increases ...

has announced that its algorithm for mitotic figure counting has achieved CE marking under the In Vitro Diagnostic Regulation (IVDR) for use in diagnostics. This milestone establishes Aiosyn ...

IVDR is a set of regulations that came into effect on May 26, 2022 that were put in place by the Europe Union (EU) to ensure the safety, traceability, quality and performance of in-vitro ...