CE marking certifies a medical device's conformity: essential pointers for buyers.

CE marking shows a medical device meets the applicable safety and performance requirements. It is a prerequisite for the European market and a widely recognised reference.

Device classes

Devices are classified by risk (I, IIa, IIb, III). The class drives the level of assessment and required documentation.

Documentation to request

  • Declaration of conformity
  • Instructions for use and labelling
  • Available technical file
  • Device identifier and traceability

Watch-points

Check consistency between intended use, class and documentation. When in doubt, ask the manufacturer: a serious supplier provides these without difficulty.