The European Committee for Electrotechnical Standardization (CENELEC) has released a draft of the EN IEC 62115-2:2026 standard, introducing stricter requirements for radiofrequency/LED/microcurrent beauty devices. Set to take effect in Q3 2026, the new regulations will impact manufacturers, exporters, and supply chains, particularly those unprepared for electromagnetic compatibility (EMC) testing and safety certifications.

Event Overview

On April 5, 2026, CENELEC published the EN IEC 62115-2:2026 draft, which updates safety standards for beauty devices. Key changes include EMC immunity thresholds, skin contact temperature limits, and user misuse protection. The regulation will become mandatory in Q3 2026, affecting products entering the EU market.

Impact on Sub-Sectors

Manufacturers and OEMs

Small and medium-sized Chinese OEMs lacking EMC pre-testing capabilities may face market exclusion. Larger manufacturers with full CE MDR, EN 60335, and EN 62115 certifications stand to gain competitive advantages.

Exporters and Distributors

Companies exporting beauty devices to the EU must ensure compliance with the new standards. Non-compliant inventory may require rework or face rejection at customs, increasing costs and delays.

Supply Chain Providers

Component suppliers and testing labs will see increased demand for EMC-compliant parts and certification services. Providers offering turnkey compliance solutions may benefit from higher engagement.

Key Focus Areas and Recommended Actions

Prioritize Compliance Testing

Manufacturers should conduct EMC and thermal performance tests immediately to identify gaps. Early compliance reduces last-minute certification bottlenecks.

Review Product Designs

Redesigns may be necessary for devices exceeding new temperature limits or lacking misuse safeguards. Focus on RF/LED/microcurrent product lines first.

Update Technical Documentation

Align technical files with EN IEC 62115-2 requirements, including risk assessments and test reports. Documentation audits should precede formal certification applications.

Monitor Certification Timelines

With the Q3 2026 deadline, schedule Notified Body assessments well in advance. Expect longer lead times due to anticipated demand surges.

Industry Perspective

From an industry standpoint, this regulation signals the EU's tightening safety framework for aesthetic devices. While posing challenges for smaller players, it creates opportunities for compliant manufacturers to differentiate. The phased implementation allows for adaptation, but proactive measures are critical given testing and certification lead times.

Conclusion

The EN IEC 62115-2 update represents a significant shift in EU beauty device regulations. Companies should treat this as an urgent compliance priority rather than a distant deadline. Early adopters may secure first-mover advantages in a consolidating market.

Source Information

Primary source: CENELEC EN IEC 62115-2:2026 draft publication (April 5, 2026). Ongoing monitoring recommended for final implementation guidelines expected in late 2025.