In 2026, the EU has strengthened compliance and market surveillance.
1.Mandatory e‑DoC FilingElectronic Declaration of Conformity replaces paper versions. Must include traceability code and report number.
2.Stricter Market Surveillance
·Document consistency
·Product authenticity
·Labeling compliance (CE mark ≥5mm, permanent)
3.Directive Updates
·RED: Stricter spurious emissions in sleep mode for BLE
·MDR: New clinical risk warnings for Class I medical devices
·EMC: Test equipment calibration numbers required
II. Products Requiring CE Certification in 2026
·Electronics, machinery, medical devices, toys, construction products
·Smart wearables with health monitoring: Class I medical device
·Wireless car chargers: EMC + LVD + RED
III. 2026 CE Process
1.Select directives and accredited labs
2.Prepare traceable documents
3.Lab testing
4.e‑DoC registration
5.Marking and archiving (files kept ≥10 years)
For more information, follow BLUEASIA.Contact: +86 13534225140 (WeChat same number)
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