Compliance with EN IEC 61010 2 101 is critical for in vitro diagnostic (IVD) devices placed on the EU market, yet the EU Group Differences introduced in EN IEC 61010 2 101:2022/A11 add substantial requirements beyond the base IEC standard. This webinar will provide regulatory professionals with a clear, technical understanding of those deviations and their impact on design controls, testing, labeling, EMC, functional safety, and risk management under IVDR. The session will also address additional safety considerations for IVDs incorporating lasers or LEDs, including applicable radiation standards and regional regulatory expectations. Attendees will gain practical insights to better support technical documentation, Notified Body interactions, and cross functional compliance efforts for both legacy and next generation IVD systems.
Learning Objectives:
- Distinguish IEC 61010 2 101 requirements from EU Group Differences in EN IEC 61010-2-101:2022/A11.
- Identify regulatory and technical documentation impacts resulting from EU-specific deviations.
- Apply EN safety, EMC, functional safety, and risk management expectations to IVDR submissions.
- Evaluate additional compliance considerations for IVDs incorporating lasers.
Audience Learning Level:
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Who Should Attend:
This program is designed for product development engineers, compliance engineers, and regulatory affairs professionals supporting in vitro diagnostic (IVD) devices for the EU market, particularly those involved in electrical safety, risk management, and IVDR submissions, Notified Body interactions, and harmonized standards compliance.
It is especially relevant for professionals responsible for interpreting and applying EN IEC 61010-2-101 EU Group Differences within technical documentation and regulatory strategies. Attendees supporting IVDs that incorporate lasers or LEDs, or managing legacy device remediation for ongoing EU compliance, will find the content highly applicable.
Speaker
James Benscoter
