The CE mark isn't a certificate — it's a manufacturer's self-declaration. Slap CE on a product and you're legally claiming it meets all applicable directives. What backs that claim? Technical files. Without them, the mark means nothing.
A smart speaker with Wi-Fi falls under four directives simultaneously: RED, LVD, EMC, and RoHS. Miss one and the CE mark doesn't hold. Common directives include 2014/30/EU (EMC), 2014/35/EU (LVD), 2014/53/EU (RED), (EU) 2023/1230 (Machinery), (EU) 2017/745 (Medical Devices), (EU) 2016/425 (PPE), (EU) 2024/3110 (Construction Products CPR), and 2011/65/EU (RoHS).
2. CE Technical File System
The technical file is a complete set of documents, not a single file.
2.1 Product Description and Design Documents
Product name, model, specifications, intended use, and user manual. Manuals sold in local markets need local language versions. If you're only transiting through without selling, English works.
Design drawings must be complete: structural diagrams, PCB layout, electrical schematics, assembly drawings, and BOM. The BOM doesn't just list part numbers and suppliers — critical components need compliance certificates attached (FCC, KC, BQB, etc.). For antennas, OEM-specified production antennas only need spec sheets; custom PCB antennas require simulation or measurement data.
2.2 Test Reports and Lab Qualifications
In-House Lab Prerequisites
EMC and LVD can genuinely use in-house labs, but the lab must hold ISO 17025 accreditation. Reports from unaccredited in-house labs won't be accepted in the EU. For high-risk categories like high-power equipment, some member states prioritize ILAC-MRA third-party reports.
RF Products Don't Need Notified Bodies
Under the RED directive, standard Wi-Fi and Bluetooth RF testing only requires an ILAC-MRA accredited lab report. Notified body involvement is only needed for high-power broadcast and automotive V2X.
Risk Assessment
Risk assessment scrutiny has tightened, but you can't mix up standards. EN ISO 12100 only applies to machinery. LVD uses EN 62368-1 or EN 60950-1 with built-in assessment. RED RF references EN 300 328.
DoC — Declaration of Conformity
The DoC is a formal document signed by the manufacturer, listing product identification, manufacturer name and address, applicable directives and standards, signer information, and date.
One common trap: EC-REP information doesn't go in the DoC. The DoC only carries the overseas manufacturer's own information. EC-REP documentation stays in the internal technical file.
Document Retention Periods
Retention periods differ by directive. RED, EMC, LVD, and GPSR require 10 years after the last product enters the EU market. Construction products CPR requires 15 years. Medical devices MDR can range from 15 to 30 years depending on the product. Don't blanket-apply 10 years across the board.
3. Construction Products and DoP
Construction windows, doors, tiles, and insulation materials need an extra document beyond the DoC — the Declaration of Performance (DoP).
DoP Core Content
Products with EN harmonized standards or ETA technical assessments must issue a DoP before market entry. Content includes product identification code, EN standard or ETA number, intended use, seven performance characteristics, AVCP system number, and manufacturer information.
Electronic DoP Timeline
The new CPR regulation (EU) 2024/3110 took effect on January 8, 2025. Many assume electronic DoP is mandatory by 2026 — it's not. Electronic DoP becomes mandatory on January 8, 2028. The 2026-2027 period is transitional; paper DoPs remain legal.
4. Timelines You Shouldn't Mix Up
RED 3.3 Cybersecurity
RED Article 3.3 paragraphs d, e, f covering networked device security didn't just land in 2026 — they've been mandatory since August 1, 2024. What's new in 2026 is increased enforcement and spot-check intensity. Also, only devices connecting to public networks need full security documentation. Pure LAN devices can exempt some materials.
GPSR and DPP
The General Product Safety Regulation GPSR (EU) 2021/840 has been fully effective since June 16, 2024. Digital Product Passport (DPP) rolls out by product category in phases — consumer goods won't see mandatory DPP until after 2027. In 2026 it's still draft stage.
5. CE Certification Core Logic
CE can't really be simplified. Too many factories think one test report wraps it up, then get caught at spot checks with incomplete files, unsigned DoCs, or missing directives. CE isn't about one test report — it's a documentation system that holds up under scrutiny. As long as the product hasn't changed and standards haven't updated, the files remain valid long-term. Change the hardware, swap a component, or update a standard, and you must reassess.
For CE certification document checklist and more, contact BlueAsia technical testing and certification consultant at 13534225140 (king) or king.guo@cblueasia.com
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