EU CENELEC Publishes EN IEC 60601-2-57:2026 Safety Standard for Non-Laser Medical and Aesthetic Devices

Details of the Update

The standard establishes essential safety and performance requirements for optical radiation devices used in therapeutic, diagnostic, monitoring, and aesthetic procedures. It introduces enhanced risk group classification, hazard labeling, and operator instructions to mitigate risks including skin burns and eye damage. 

Manufacturers must document risk group classification for all covered optical radiation sources and ensure uniform light output verification. High-risk devices are required to carry durable hazard labeling with exposure information and include clear instructions on protective measures for operators.

The scope is limited to professional-use equipment and explicitly excludes home-use appliances and sunbeds. 

Alignment with EU MDR

Devices compliant with the standard benefit from presumption of conformity to EU MDR requirements starting in January 2026. Manufacturers of clinical phototherapy systems, diagnostic imaging devices, monitoring equipment, and aesthetic devices using non-laser optical radiation must align technical documentation and labeling practices to maintain EU market access.

Effective Date

The standard EN IEC 60601-2-57:2026 enters into force on 1 January 2026, establishing formal compliance requirements for non-laser light source medical and aesthetic equipment in the European Union.

Why It Matters

This update provides regulatory clarity by harmonizing safety expectations for non-laser optical radiation devices under the EU MDR framework. It supports technical and digital alignment through standardized verification and documentation requirements, enhances operational efficiency, and maintains a neutral regulatory burden for manufacturers already operating under MDR obligations.

Who This Is Relevant For

This update is relevant for Regulatory Affairs, Quality Assurance, R&D, Engineering, and IT teams responsible for product design, risk management, technical documentation, and MDR compliance of optical radiation-based medical and aesthetic devices.

Next Steps

Regulatory teams should assess current product portfolios against the new standard, review risk classification and labeling practices, and coordinate with R&D and quality teams to ensure technical documentation and instructions for use support MDR presumption of conformity.

As organizations prepare for the application of this new CENELEC standard, RegASK helps teams stay ahead of evolving EU safety requirements. RegASK is a leading agentic AI regulatory intelligence and workflow orchestration platform that empowers global organizations in highly regulated sectors, including consumer products and life sciences, to proactively navigate complex regulatory landscapes. By combining advanced Agentic AI with experts in the loop, RegASK delivers timely predictive actionable insights and end-to-end automation, streamlining compliance processes, mitigating risks, and accelerating market access across more than 160 countries. Learn more or book a demo now. 

FAQs

What is the new CENELEC standard for non-laser light source medical equipment? 

It is a European safety standard published on 27 February 2026 that defines safety and performance requirements for professional-use medical and aesthetic devices emitting UV, visible, or IR radiation from non-laser sources. 

When does EN IEC 60601-2-57:2026 take effect? 

The standard takes effect on 1 January 2026.

Which devices fall under the scope of this standard?

It applies to professional-use medical and aesthetic equipment used in therapy, diagnostics, monitoring, and cosmetic procedures, excluding home-use devices and sunbeds.

How can RegASK support compliance with this standard?

RegASK enables teams to track applicable standards, assess MDR impact, and align documentation workflows, supporting efficient compliance with new EU safety and performance requirements.