CE Marking is one of the most recognized symbols in global trade. Yet few manufacturers and conformity assessment bodies understand the legal framework behind it. Based on insights from a recent webinar by Perry Johnson Laboratory Accreditation (PJLA), this article breaks down the EU notification process, explains why accreditation alone is not enough, and outlines how products legally gain access to the European market.
The Compliance System Most Companies Never See
When a product carries the CE Mark, many assume it simply means it passed a test. That mark represents:
- European legislation
- Government oversight
- Technical conformity assessment
- Legal authorization
- Continuous market surveillance
In PJLA’s recent webinar, George Anastasopoulos explained how the system truly functions.
“This presentation explains the real mechanism behind EU notification and conformity assessment; not just the symbol you see on the product.”
Without proper notification, no laboratory or certification body can legally approve CE-marked products, even if fully accredited.
Why EU Notification Is the Gateway to the European Market
The European Union is one of the world’s largest regulated markets, importing products from North America, Asia, and beyond.
Understanding notification provides both regulatory compliance and business advantage.
Benefits of EU Notification
| Advantage | Business Impact |
| Legal authority | Certify CE-marked products |
| Market access | Sell across 30+ EU countries |
| Reduced risk | Avoid regulatory violations |
| Faster approvals | Streamlined conformity |
| Increased trust | Government-recognized competence |
As George emphasized:
“Notification is the passport that opens the commercial door of the European Union.”
Accreditation vs Notification: The Most Common Compliance Mistake
Many organizations mistakenly believe accreditation equals legal approval.
Accreditation Provides:
- Technical competence
- ISO standard compliance
Notification Provides:
- Legal authority to issue CE-related conformity assessments
- Recognition by EU regulators
- Listing in the official NANDO database
“Accreditation is required, but it does not mean notification. Without notification, CE-related activities have no legal standing.”
What CE Marking Really Means
CE Marking is not a quality seal or voluntary label.
It is a legal declaration that a product complies with European safety, health, and environmental regulations.
CE Marking Confirms
| Area | Purpose |
| Consumer safety | Prevents hazardous products |
| Harmonized rules | Same standards across Europe |
| Legal accountability | Manufacturer responsibility |
| Market freedom | EU-wide product movement |
George explained:
“CE Marking is not a certification level; it is a legal commitment that a product complies with EU requirements.”
When Notified Bodies Are Required
While a few low-risk products allow self-declaration, most regulated products must be assessed by a notified body.
Common Product Categories Requiring Third-Party Assessment
| Industry | Examples |
| Medical devices | Surgical tools, diagnostics |
| Machinery | Industrial equipment |
| Electrical products | Chargers, radios |
| Consumer products | Toys, electronics |
| Emerging technologies | AI & cybersecurity |
| Environmental | Packaging & waste |
Many products fall under multiple EU regulations, increasing the need for careful classification.
Who Issues EU Notification?
EU notification is granted by national authorities within EU Member States, not by accreditation bodies.
The Three-Level Structure
| Level | Role |
| Accreditation bodies | Technical evaluations |
| National authorities | Legal designation |
| European Commission | Central registry |
Once notified in one EU country, recognition applies across all EU Member States.
Europe’s Unique Accreditation Framework
Under EU Regulation 765/2008:
- Each country has one national accreditation body
- No competition between states
- Government-backed authority
These bodies support notification technically but do not grant legal approval.
Can Non-EU Organizations Become Notified?
Yes, through Mutual Recognition Agreements (MRAs).
Countries with EU MRAs
Eligible Countries:
United States, Canada, Australia, Japan, New Zealand, Switzerland, Turkey
Organizations outside these countries must establish an EU-based entity to pursue notification.
CE Compliance Does not End at Certification
European market surveillance authorities routinely:
- Inspect products in stores
- Perform independent testing
- Review technical documentation
- Enforce recalls and penalties
“You cannot certify one compliant product and later downgrade quality; surveillance systems will catch it.”
The Most Common Regulatory Errors
| Mistake | Result |
| Confusing accreditation with notification | Illegal approvals |
| Wrong directive selection | Delays and redesign |
| Missing multiple regulations | Non-compliance |
| Outdated standards | Invalid certification |
| Poor documentation | Rejection |
| Ignoring surveillance | Fines & bans |
George warned:
“Approval in one non-EU country does not transfer to Europe, and compliance must be continuous.”
Why Understanding EU Notification Matters Today
With expanding EU regulations in:
- Medical technology
- Artificial intelligence
- Cybersecurity
- Environmental compliance
Conformity is becoming more complex, and more strictly enforced.
Organizations that understand notification early:
- Enter markets faster
- Avoid costly redesigns
- Protect legal standing
- Strengthen credibility
Watch the Full Webinar
Explore the complete explanation of EU notification and CE Marking here: https://youtu.be/uz4qX0plB7k?si=uXvSS7KRH2Jpord3
About PJLA
Perry Johnson Laboratory Accreditation (PJLA) is a globally recognized accreditation body established in 1999 and headquartered in Troy, Michigan. PJLA has performed more than 2,200 accreditations in over 30 countries, supporting laboratories, inspection bodies, and certification organizations in achieving internationally recognized competence.
PJLA is recognized internationally through major cooperation frameworks including International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Accreditation Cooperation (APAC).
PJLA Contact Information
Website: www.pjlabs.com
Email: [email protected]
Phone: +1 (248) 519-2603
