New IVDR Compliance: Get Ready with confinis

Urgency of Compliance

The transition period for the new European In-vitro Diagnostic Medical Devices Regulation (IVDR, (EU) 2017/746) is nearing its end. Having replaced the older In-vitro Diagnostic Medical Devices Directive (IVDD, 98/79/EC), the new regulation mandates full compliance by May 26th, 2022. This tight deadline makes it imperative for manufacturers and stakeholders in the diagnostic medical devices industry to ensure their products meet the new standards promptly.

How confinis Can Help

At confinis, our in-vitro diagnostic medical device experts are equipped to guide you through every step of the IVDR implementation process. From initial assessment to final certification, our comprehensive support includes:

Why IVDR Compliance is Critical

  • Strategic IVDR Compliance Planning

    We develop a tailored strategy that encompasses all aspects of IVDR compliance, ensuring that your approach is both pragmatic and effective. This strategy will focus on establishing or enhancing your Quality Management System, refining product technical documentation, and facilitating smooth submissions and interactions with notified bodies.

  • Technical Documentation and Quality Management

    Our experts will assist in preparing and reviewing the necessary technical documentation required under IVDR. This includes performance evaluations, clinical evidence reports, and risk management files, all aligned with the stringent requirements of the new regulation.

  • Notified Body Interaction

    With extensive experience in regulatory affairs, our team will support you in managing communications with notified bodies, ensuring that your compliance efforts are recognized and validated without delays.

Achieving compliance with IVDR is not just about adhering to legal requirements—it’s about securing your market presence in Europe and other international markets that recognize the European CE marking. Ensuring IVDR readiness is crucial for continued access to these markets and for maintaining the trust of consumers and healthcare professionals in the safety and efficacy of your diagnostic products.

Stay Ahead with confinis

Don’t let the compliance deadline catch you unprepared. Partner with confinis to navigate the complexities of IVDR and ensure your in-vitro diagnostic devices continue to meet the highest standards of market entry and patient safety.