Introduction: If your In Vitro Diagnostic (IVD) device has made its way into the European market and is currently compliant with IEC 61010-2-101, there’s crucial information you need to be aware of. In August of 2023, the International Electrotechnical Commission (IEC) introduced new European Group Differences to IEC 61010-2-101, bringing about significant changes that demand your attention.
Key Changes: These notable changes encompass various aspects crucial to the functionality and safety of your IVD device. They include a heightened focus on:
- Hand-Transmitted Vibration
- Is your or your partner test lab capable of conducting this test?
- Consideration of Electromagnetic Disturbances:
- Addressing potential electromagnetic disturbances becomes a pivotal aspect, ensuring the resilience of your IVD device in real-world scenarios.
- Functional Safety Requirements:
- Functional safety aims to enhance the overall reliability and performance of your IVD device.
- Usability Engineering:
- A renewed emphasis on usability engineering ensures your device is user-friendly, meeting the evolving expectations of both healthcare professionals and end-users.
- Static Electricity Mitigation:
- Mitigating static electricity is critical for the proper functioning of electronic components, safeguarding your IVD device against potential issues.
- Risk Management:
- The updated standards place a heightened focus on comprehensive risk management, ensuring potential risks are identified, assessed and mitigated effectively.
Compliance Transition: For those well-versed in the IEC 60601 series of standards, transitioning your IVD device into a Quality Management System that aligns with the additional requirements imposed by the European Deviations to IEC 61010-2-101 should be a relatively straightforward task. However, if your compliance department predominantly works with the IEC 61010-1 series of standards it might be the opportune moment to consider external expertise.
Why Choose Medeq Consulting, LLC: Engaging with a seasoned partner like Medeq Consulting, LLC can prove invaluable during this transition phase. We offer comprehensive services, including training sessions, GAP analyses and collaborative partnerships with your compliance department. Our goal is to ensure your IVD device meets the updated European requirements so when it is time to update the technical file it’s as simple as marking the applicable clauses as “Pass”.
Conclusion: Staying abreast of regulatory changes and ensuring your IVD device complies with the latest standards is crucial for sustained success in the European market. With the right expertise and support, your device can navigate the intricacies of European Deviations to IEC 61010-2-101 seamlessly, ensuring both compliance and excellence in performance. Contact us or request a quote today!