Short answer: CE marking shows that a device meets EU requirements and can be sold in the EU. For surgical instruments, the manufacturer classifies the device, prepares technical documentation, follows the required conformity assessment (with a notified body for Class Ir and Is) and signs an EU declaration of conformity.
CE marking under the MDR
- Classify the device
- Meet general safety and performance requirements
- Prepare technical documentation
- Conformity assessment (notified body where required)
- Issue EU declaration of conformity
- Register in EUDAMED as required
- Affix CE mark
- Post-market surveillance
What buyers should see
- CE mark: On label and device where applicable
- Notified body number: Next to CE mark for Ir and Is
- Declaration of conformity: Signed by manufacturer
- Manufacturer details: On label
- Authorised representative: For non-EU makers
- UDI: Where required
Checking a CE claim
- Declaration of conformity available
- Class stated
- Notified body number if required
- Certificate valid and covering product
- Labels match documentation
In detail: legacy CE marks
Some instruments are still sold under certificates or declarations from the old Medical Device Directive during the MDR transition. Check that the transition conditions are met.
Worked example
A distributor receives instruments with a CE mark but no notified body number, labelled “reusable”. It asks the maker for clarification, since reusable instruments are usually Class Ir requiring notified body involvement.
Proof box
Proof: EU MDR Article 20 covers the CE marking; Annex VIII covers classification rules, including rules for reusable surgical instruments.
Frequently asked questions
Is CE marking a quality mark? It shows legal conformity, not a quality grade.
Who affixes the CE mark? The manufacturer.
Is CE required outside the EU? Some countries accept it as evidence; requirements vary.
What is a notified body number? A four-digit number identifying the body.
Glossary
- Conformity assessment: process to show compliance.
- Declaration of conformity: formal statement of compliance.
- EUDAMED: EU device database.
Key takeaways
- CE = legal conformity in the EU
- Check class and notified body number
- Ask for the declaration
Standards and sources
- EU MDR text
- European Commission: medical devices
- Related: EU MDR guide (see The EU MDR for surgical instrument distributors: the complete guide)
Ask Tata Surgical
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