EU Type Examination
EU type-examination is the procedure by which a Notified Body examines, tests, and certifies a representative type of a product as meeting the essential safety requirements of the applicable EU regulation.
Procedure:
1. Manufacturer submits application and technical documentation
2. Notified Body reviews documentation (technical file, risk analysis, clinical evaluation for medical devices)
3. Physical testing of the type specimen
4. Assessment of conformity with harmonised standards
5. Issue of EU type-examination certificate if positive
Validity: type-examination certificates have a limited term (typically 5 years for medical devices under MDR) and must be renewed.
Legal basis:
- Medical devices (MDR): Annex X (type-examination) and Annex IX (QMS assessment with sample examination)
- PPE (PPE Regulation): Article 19 (EU type-examination)
Important: the EU type-examination certificate is only one of several possible routes to CE marking - the manufacturer must additionally conduct a conformity assessment procedure for ongoing production.
Frequently asked questions
What is the difference between EU type-examination and CE marking?
EU type-examination is one part of the conformity assessment - it tests the product type. CE marking is the result of the complete procedure: type-examination PLUS conformity of ongoing production. CE marking may only be applied after the full procedure is complete.
How long is an EU type-examination certificate valid?
For medical devices under MDR, certificates are typically valid for 5 years. For PPE under the PPE Regulation, validity may vary. After expiry, a renewal assessment by the Notified Body is required.
What happens if a product is modified and a type-examination certificate exists?
Substantial modifications require a new or supplemented type-examination. The manufacturer must notify the Notified Body of any planned changes. Minor changes may under certain conditions be covered by a supplement to the existing certificate.