CE Marking Checklist

For manufacturers & importers entering the EU / EEA market · eucertify.com

2026 Edition

How to use: Work through each step in order. Tick items as you complete them. Requirements vary by product category and directive — always confirm with a compliance specialist for your specific product. This checklist covers the general CE marking path; product-specific regulations (MDR, ATEX, CPR, etc.) add further requirements.

Required Applies to virtually all products

Conditional Depends on product / directive

Optional Best practice / recommended

Identify Applicable Directives & Regulations

Define product category, intended use and target market Electronics, machinery, medical device, toy, PPE, construction product, radio equipment, etc.

Required

Identify all applicable EU directives and regulations LVD (2014/35/EU) · EMC (2014/30/EU) · RED (2014/53/EU) · Machinery (2006/42/EC) · MDR (2017/745) · IVDR (2017/746) · PPE · Toys · CPR…

Required

Check product-specific substance and environmental regulations RoHS (2011/65/EU) · REACH (1907/2006) · WEEE (2012/19/EU) · F-Gas · Battery Regulation (2023/1542)

Conditional

Confirm if UK UKCA or Swiss conformity mark is also required CE marking alone is no longer valid in Great Britain post-Brexit. Switzerland requires CH mark for some product categories.

Conditional

Harmonised Standards & Essential Requirements

Identify applicable harmonised EN standards (Official Journal list) Applying harmonised standards gives presumption of conformity with the corresponding essential requirements.

Required

Verify standards are current — not withdrawn or superseded Check the latest OJ list. Transition periods after withdrawal of old editions must be respected.

Required

Address any essential requirements not covered by harmonised standards Risk assessment and engineering judgement required where no harmonised standard exists.

Required

Testing & Conformity Assessment Route

Determine conformity assessment module (A, B+C, D, E, F, G, H) Module A = internal control (lower-risk products). Higher-risk categories require Notified Body involvement.

Required

Select accredited test laboratory (ISO/IEC 17025) for required tests Safety, EMC, radio, performance, chemical. Verify lab accreditation scope covers your product and standards.

Required

Obtain full test reports referencing applicable standards Reports must be traceable, include sample identification and be retained with the technical file.

Required

Engage Notified Body (NB) where third-party assessment is mandatory Required for: medical devices Class IIa+, PPE Category III, certain radio equipment, pressure equipment PED Cat. II+.

Conditional

Technical Documentation (Technical File)

Product description, design drawings, schematics, BOM Sufficient detail to demonstrate compliance. Must cover all variants / model numbers in scope.

Required

Risk assessment / FMEA or equivalent Documented risk identification, evaluation and mitigation. Mandatory under virtually all CE directives.

Required

Full test reports and measurement results Referenced standards, test dates, lab name and accreditation number, conclusions.

Required

User instructions / manual in all required EU languages Must be in the official language(s) of each member state where product is placed on the market.

Required

Technical file stored and accessible for minimum 10 years Must be made available to market surveillance authorities upon request within a reasonable time.

Required

EU Authorised Representative (EAR) — Non-EU Manufacturers

Confirm whether EAR is required for your directive(s) Required under LVD, EMC, RED, Machinery, MDR/IVDR, PPE and others for manufacturers outside the EU/EEA.

Conditional

Appoint a registered EU Authorised Representative in an EU member state EAR name and address must appear on product labelling or packaging. Written mandate required.

Conditional

Provide EAR with DoC, technical file and product information EAR must be able to cooperate with market surveillance authorities and provide documentation on request.

Conditional

Check additional representative requirements (GDPR Art. 27, DSA Art. 13, Swiss FADP) Data processing or digital services in EU / Switzerland may require separate regulatory representatives.

Conditional

Declaration of Conformity & CE Marking

Draw up EU Declaration of Conformity (DoC) Must include: manufacturer name/address, product ID, applicable directives, standards applied, NB number (if any), date and signature.

Required

Affix CE marking — visible, legible, indelible; min. height 5 mm On product, packaging or accompanying document (directive-dependent). Proportional scaling only; no modification to shape.

Required

Add Notified Body identification number after CE mark (if applicable) Four-digit NB number follows CE mark where conformity assessment involved a Notified Body.

Conditional

Market Registration & Post-Market Obligations

Register in EUDAMED (medical devices & IVDs) Mandatory before placing on market under MDR/IVDR. Covers manufacturer, device and UDI registration.

Conditional

Register in EPREL (energy-related products) Mandatory before advertising or placing energy-labelled products on the EU market.

Conditional

Establish post-market surveillance & serious incident reporting Ongoing obligation for all CE-marked products: monitor field performance, handle complaints, report serious incidents to authorities.

Required

Ensure WEEE producer registration in each target member state Required for electrical & electronic equipment. National registration mandatory before placing on market in each country.

Conditional

Typical CE marking timeline

Low-risk products (Module A): 2–4 months · Medium-risk (with testing): 4–8 months · High-risk with NB: 8–18 months. Start early — most delays come from documentation gaps and lab backlogs, not the certification process itself.

Common reasons for failure

Missing or incorrect risk assessment · Using withdrawn standards · Incomplete technical file · No EU Authorised Representative · Incorrect CE marking dimensions · User manual not in required languages.