EU Deviations to IEC 61010-2-101: What IVD Manufacturers Need to Know

11:00 a.m. Eastern U.S. | 6:00 p.m. Central Europe 

Compliance with EN IEC 61010‑2‑101 is critical for in vitro diagnostic (IVD) devices placed on the EU market. However, the EU Group Differences introduced in EN IEC 61010‑2‑101:2022/A11 add substantial requirements beyond the base IEC standard.

This webinar, hosted by the Regulatory Affairs Professionals Society (RAPS), will provide regulatory professionals with a clear, technical understanding of these deviations and their impact on design controls, testing, labeling, EMC, functional safety and risk management. The session will also address additional safety considerations for IVDs incorporating lasers or LEDs, including applicable radiation standards and regional regulatory expectations.

You will hear practical insights that can help you better support technical documentation, notified body interactions and cross‑functional compliance efforts for both legacy and next‑generation IVD systems.

In this session, UL Solutions experts will show you how to:

• 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.
• Engineering applications of EN safety, EMC, functional safety and risk management expectations.
• Evaluate additional compliance considerations for IVDs incorporating lasers.

The RAPS-hosted webinar is designed for product development engineers, compliance engineers and regulatory affairs professionals supporting IVD devices for the EU market, particularly those involved in electrical safety, risk management, 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 those managing legacy device remediation for ongoing EU compliance, will find the content highly applicable.

Speakers

James Benscoter, principal engineer

Winn Henderson, principal engineer