CE Self-Declaration vs Notified Body Assessment
Compare CE marking self-declaration vs assessment by a Notified Body: when each is required, costs, and timelines.
CE Marking Routes
Self-Declaration
Manufacturer declares conformity themselves based on testing against harmonized standards. Applicable for low-risk product categories.
Pros
- ✓Lower cost
- ✓Faster process
- ✓Full control over timeline
- ✓No third-party fees
Cons
- ✗Manufacturer bears full liability
- ✗Must understand all applicable standards
- ✗Market surveillance can challenge
- ✗Requires technical expertise
Best for: Low-risk products (electronics, toys under certain conditions)
Cost: ask the operator for the current rate; this page does not invent a range
Setup: Confirm timing with the operator or competent authority 2-6 weeks
Notified Body
Independent third-party organization assesses conformity. Required for higher-risk products under specific EU directives.
Pros
- ✓Third-party validation
- ✓Higher market credibility
- ✓Reduced liability risk
- ✓Expert guidance
Cons
- ✗Higher cost (€5,000-50,000+)
- ✗Longer timeline
- ✗Scheduling dependencies
- ✗Annual audits
Best for: Medical devices, machinery, pressure equipment, PPE
Cost: ask the operator for the current rate; this page does not invent a range
Setup: Confirm timing with the operator or competent authority
FAQ
How do I know if my product needs a Notified Body?+
Check the applicable EU directive for your product. If the directive requires a Notified Body (listed in Annex I or similar), you must use one. Common examples: medical devices (MDR), machinery with complex safety systems, PPE.