CE Marking – Complete Compliance Guide (2024)
1. What is CE Marking?
- Mandatory conformity mark for products sold in the European Economic Area (EEA)
- Indicates compliance with EU health, safety, and environmental standards
- Not a quality certification but a legal requirement for 23 product categories
- Self-declared by manufacturers (for some products) or requires Notified Body involvement
Key Facts:
✔ Applies to: Machinery, electronics, medical devices, toys, PPE, etc.
✔ Not for: Food, chemicals, pharmaceuticals (they have separate regulations)
✔ Replaced by UKCA for Great Britain (but still accepted until 2024)
2. Product Categories Requiring CE Marking
| Product Category | Applicable Directive/Regulation | Notified Body Required? |
| Medical Devices | MDR (EU) 2017/745 | Yes (Class IIa and above) |
| Machinery | Machinery Directive 2006/42/EC | Sometimes |
| Toys | Toy Safety Directive 2009/48/EC | No (self-certification) |
| PPE | Regulation (EU) 2016/425 | Yes (Category II & III) |
| Electronics | LVD, EMC Directives | No (self-certification) |
| Construction Products | CPR (EU) 305/2011 | Sometimes |
3. Step-by-Step CE Marking Process
Step 1: Identify Applicable Directives
- Check if your product falls under 1+ EU directives (e.g., EMC, RoHS, Machinery Directive)
Step 2: Conduct Conformity Assessment
- Self-certification (for low-risk products)
- Test internally or via a lab
- Prepare Technical Documentation
- Notified Body (for high-risk products)
- Independent assessment required
Step 3: Prepare Technical Documentation
- Essential requirements checklist
- Risk assessment report
- Test reports (EMC, safety, etc.)
- User manuals & warnings
Step 4: Draft EU Declaration of Conformity (DoC)
- Must include:
✔ Manufacturer/importer details
✔ Product model & serial number
✔ Applied directives & standards
✔ Notified Body info (if applicable)
Step 5: Affix CE Mark
- Minimum height: 5mm
- Must be permanent & visible
- No other marks should obscure it
Step 6: Maintain Compliance
- Keep records for 10 years
- Update if regulations change
4. Costs of CE Marking
Cost-Saving Tips:
✅ Self-certify if allowed (e.g., basic electronics)
✅ Use harmonized standards to simplify testing
✅ Test prototypes early to avoid redesigns
5. CE vs. UKCA Marking (Post-Brexit)
| Aspect | CE Marking | UKCA Marking |
| Validity | EEA (EU + Norway, Iceland) | Great Britain only |
| Transition Period | Accepted in UK until Dec 2024 | Required from Jan 2025 |
| Standards | EN (EU harmonized) | BS (UK standards) |
| Notified Bodies | EU-recognized | UK-approved |
Note: Northern Ireland still uses CE marking under the Windsor Framework.
6. Common Mistakes & How to Avoid Them
| Mistake | Solution |
| Assuming all products need CE | Check the EU directives list first |
| Using outdated standards | Always check OJEU (Official Journal) for updates |
| Incorrect labeling | Follow sizing & placement rules |
| Missing post-market surveillance | Set up a system to track incidents |
7. Benefits of CE Marking
✔ Legal access to EU market (500M+ consumers)
✔ Reduced liability risks (proves due diligence)
✔ Competitive advantage (trusted by buyers)
✔ Easier customs clearance
8. FAQs
Q: Can I CE mark my product myself?
A: Yes, if it’s low-risk (e.g., toys, basic electronics). High-risk products (e.g., medical devices) require a Notified Body.
Q: How long does CE certification take?
A: 2 weeks (self-certification) to 6+ months (for complex products needing Notified Body approval).
Q: Is CE marking enough for the US?
A: No – The US requires FCC, UL, or FDA approvals instead.
9. Need Help?
- For self-certification: Download our free CE checklist
- For Notified Body products: Get a list of EU-approved labs
- For UKCA transition: See our step-by-step guide