If you’re a manufacturer looking to sell your product in the European market, CE marking is a legal must. It’s more than just a label. It shows that your product meets the European Union’s health, safety, and environmental standards.
But getting that CE mark doesn’t happen overnight. It involves several steps, and each one takes time. This guide will help you understand what to expect at every stage of the process so you can plan smarter and avoid last-minute surprises.
Let’s walk through the CE timeline, from the very beginning of classification to the final certification.
Step 1: Product Classification (1–2 weeks)
Before anything else, you need to classify your product correctly. This is especially important for medical devices, machinery, or electronics.
Ask yourself:
- What does the product do?
- Who uses it?
- Where and how is it used?
This classification decides the route you’ll follow for CE marking. For example, a low-risk medical device may need a different process than a high-risk one. Getting this step right saves you from going back and redoing the work.
If needed, you can ask a consultant or expert for help with classification. But with the right documents, most manufacturers can do this step quickly, usually within a week or two.
Step 2: Identify Applicable EU Directives and Standards (1–2 weeks)
Each product must meet certain EU laws called “Directives” or “Regulations.” Some examples:
- Medical devices follow the MDR (Medical Device Regulation).
- Electronics follow the EMC and Low Voltage Directives.
- Toys follow the Toy Safety Directive.
You’ll also need to find the “harmonized standards” , technical rules that help show your product is safe. Using these makes the process easier and faster, since they’re already accepted by the EU.
Most businesses can complete this step in one to two weeks, depending on how complex the product is.
Step 3: Risk Assessment and Technical Documentation (3–8 weeks)
This is often the most time-consuming part. You’ll need to show that your product meets safety, performance, and other key requirements.
What you’ll prepare:
- Risk analysis
- Design drawings
- Test reports
- Manufacturing process details
- Instructions for use and labeling
For simple products, this can take about 3–4 weeks. For complex items like electronics or medical devices, it may take 6–8 weeks or more, especially if testing labs are involved.
If your product needs testing, you’ll need to schedule lab time. Some labs may have waiting periods, so it’s smart to book this early.
Step 4: Involve a Notified Body (If Required) (6–12 weeks)
Some products , especially high-risk items , must be reviewed by a Notified Body (NB). These are independent organizations approved by the EU to assess products for compliance.
The Notified Body will:
- Review your documentation
- Conduct audits (if needed)
- Approve the product for CE marking
How long this step takes depends on:
- The NB’s availability
- The product’s complexity
- The quality of your documents
Expect this step to take 6 to 12 weeks. If the NB finds problems, you may need to revise and resubmit documents, which can add more time.
Tip: Contact a Notified Body early, even during the documentation stage, to book a review slot in advance.
Step 5: Draft and Sign the Declaration of Conformity (1 week)
Once all the steps above are complete, it’s time to write your Declaration of Conformity (DoC). This is a legal document where you state that your product meets all relevant EU rules.
The DoC includes:
- Manufacturer’s name and address
- Product description and model
- Directives and standards followed
- Details of the Notified Body (if used)
- Signature of an authorized person
This is a short step, most companies can draft, review, and sign the DoC in about a week.
Step 6: Affix the CE Mark (Same Day)
After you complete the Declaration of Conformity, you can apply the CE mark to your product and packaging. There are specific size and visibility rules, so check the correct format for your product type.
This step usually takes just a day, as long as you’ve prepared the artwork and labels.
Once marked, your product is legally ready for sale in the European Economic Area (EEA).
Total Estimated Timeline
Let’s put it all together:
| Step | Estimated Time |
| Classification | 1–2 weeks |
| Identify Directives | 1–2 weeks |
| Documentation | 3–8 weeks |
| Notified Body Review (if needed) | 6–12 weeks |
| Declaration of Conformity | 1 week |
| CE Marking | 1 day |
Overall time: 6 to 14 weeks (or more for complex or high-risk products).
Tips to Speed Up the Process
- Start early: Don’t wait until the last moment, especially if working with a Notified Body.
- Keep clean records: Well-organized documents reduce back-and-forth and delays.
- Use harmonized standards: These make it easier to show compliance.
- Outsource testing early: Testing labs can have long queues, get your place early.
- Stay updated: EU rules change. Make sure you follow the latest versions.
What Slows Down CE Marking?
Many delays happen when companies:
- Misclassify their product
- Submit incomplete documents
- Miss required testing
- Wait too long to contact a Notified Body
- Fail audits and need to correct problems
Planning ahead and getting the first steps right makes the entire process smoother.
Final Thoughts
CE marking may seem complex, but with the right timeline and clear steps, it becomes manageable. It’s not just a sticker on your product. It’s a signal that your item is safe, tested, and ready for European markets.
The key is to start early, follow the right route, and stay organized. Whether you’re building medical devices, machinery, electronics, or toys, you can complete the process confidently by moving step by step.
Don’t rush it. Good planning at the start avoids costly delays at the end.
