Introduction
When ensuring product compliance with EU and UK regulations, manufacturers must determine whether self-certification or third-party testing is required. Understanding the differences between these two conformity assessment procedures is crucial for ensuring products meet safety, health, and environmental requirements before entering the market.
What is Self-Certification?
Definition
Self-certification allows manufacturers to assess their own products for compliance without the need for external testing by a Notified Body (EU) or an Approved Body (UK).
When is Self-Certification Allowed?
Manufacturers can use self-certification when: ✅ Their product falls under low-risk categories. ✅ The applicable directive or regulation explicitly permits self-assessment. ✅ They can conduct necessary testing in-house or through independent laboratories.
Examples of Self-Certifiable Products
General electronic devices under the Electromagnetic Compatibility (EMC) Directive.
Simple toys that comply with EN 71-1 (Mechanical and Physical Properties).
Low-voltage electrical equipment under the Low Voltage Directive (LVD).
Household furniture under the General Product Safety Regulations (GPSR).
Pros of Self-Certification
✔️ Faster time-to-market – No waiting for third-party testing.
✔️ Lower cost – No need to pay for external assessment.
✔️ More control – Manufacturers oversee their own compliance process.
Cons of Self-Certification
❌ Higher risk – If compliance is incorrect, legal consequences apply.
❌ Regulatory scrutiny – Market surveillance authorities may audit self-certified products.
❌ Not applicable for high-risk products – Some regulations mandate third-party testing.
What is Third-Party Testing?
Definition
Third-party testing requires manufacturers to send their product to an independent, accredited testing body (Notified Body for EU or Approved Body for UK) to verify compliance with applicable regulations and directives.
When is Third-Party Testing Required?
Third-party testing is mandatory when: ✅ The directive requires certification from a Notified/Approved Body. ✅ The product poses significant risks (e.g., medical devices, pressure equipment, gas appliances). ✅ Specific harmonized standards require third-party verification.
Examples of Products Requiring Third-Party Testing
Personal Protective Equipment (PPE) under Regulation (EU) 2016/425.
Medical devices under Medical Devices Regulation (MDR) (EU 2017/745).
Pressure equipment under the Pressure Equipment Directive (PED) (2014/68/EU).
Radio equipment under the Radio Equipment Directive (RED) (2014/53/EU).
Pros of Third-Party Testing
✔️ Greater credibility – Certified by independent labs.
✔️ Lower risk – Ensures compliance with stricter regulations.
✔️ Recognized by regulatory bodies – Reduces the chance of market rejection.
Cons of Third-Party Testing
❌ Higher cost – Testing fees can be expensive.
❌ Longer approval process – Testing can take weeks or months.
❌ Less control – Compliance depends on external organizations.
Key Differences Between Self-Certification and Third-Party Testing
Feature | Self-Certification | Third-Party Testing |
Who conducts testing? | Manufacturer (in-house or independent lab) | Notified/Approved Body |
Allowed for all products? | ❌ No – Only for low-risk products | ✅ Yes – Required for high-risk products |
Cost | 💲 Lower | 💲💲 Higher |
Timeframe | ⏳ Faster | ⏳ Slower |
Regulatory scrutiny | ⚠️ Higher risk of audit | ✅ Lower risk, as an independent body verifies compliance |
Market acceptance | May face challenges in certain regions | More widely accepted worldwide |