In Vitro Diagnostic Regulation (IVDR)

PentaBase is on track to comply with IVDR 

In May 2017, a significant transformation emerged with the publication of the In-Vitro Diagnostic Regulation (IVDR), replacing the EU Commission’s former Directive (IVDD) on in vitro diagnostic medical devices (98/79/EC). Understanding the nuances between IVDD vs IVDR is crucial in navigating the evolving regulatory landscape within the EU.

The arrival of the IVDR signifies more than just regulatory change; it embodies a dynamic commitment to precision, safety, and innovation, shaping the future of in vitro diagnostics. As a company operating in this space, it’s imperative to stay informed on IVDR regulations to ensure compliance and maintain market access.

Devices that obtained the CE mark under Directive 98/79/EC retain validity during a transitional period following the IVDR’s implementation, extending until 26 May 2025. However, for devices not previously subjected to a Notified Body under the IVDD, such as General Devices, adherence to the IVDR necessitates a phased transition based on risk classification.

Making the transition from IVDD to IVDR

At PentaBase A/S, we pride ourselves on being at the forefront of delivering cutting-edge in vitro diagnostic solutions that meet and exceed the highest standards of quality and reliability. As such, we are actively engaged in the process of recertifying our product portfolio under the new IVDR legislation, ensuring continued compliance and market competitiveness.

Our commitment to quality management is evident in our QMS adherence to both ISO 13485:2016 and IVDR standards. By aligning our practices with these stringent requirements, we assure our customers of the safety, efficacy, and regulatory compliance of our products.

Provisions outline the specific classifications assigned in the IVDR. Currently is it under review if the timelines shall be extended to ensure the availability of In vitro diagnostics (IVDs)