Navigating the IVDR Transition: What Private Label Manufacturers Must Know
With the implementation of Regulation (EU) 2017/746 (IVDR), the regulatory framework for in vitro diagnostic medical devices (IVDs) in the […]
IVDR compliance
In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
The In Vitro Diagnostic Regulation (IVDR) marks a significant shift in the European Union’s regulatory framework for in vitro diagnostic
Understanding IVDR Gap Assessment and Consulting Services for Medical Devices
The In Vitro Diagnostic Regulation (IVDR) is a critical legislative framework introduced by the European Union to ensure that in
Developing and Maintaining a QMS for IVDs
In vitro diagnostics (IVDs) are crucial for detecting diseases, conditions, and infections through tests conducted outside the human body. The
Understanding the In Vitro Diagnostic Regulation (IVDR)
In Vitro Diagnostic Regulation (IVDR) EU 2017/746 took full effect, replacing the previous Directive, IVDD 98/79/EC. This new regulation significantly
Approaching IVDR Compliance: Key Considerations for In Vitro Diagnostic Devices
With the European Union’s In Vitro Diagnostic Regulation (IVDR) deadline quickly approaching, it is crucial for manufacturers to understand the