CE marking for medical devices

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CE marking for medical devices

In order to be allowed for marketing in Europe, all medical devices must comply with the following Directives:.

  • Medical Device Directive 93/42/EEC,
  • Active Implantable Medical Device Directive 90/385/EEC
  • New Directive 2007/47/EC, amending the MDD and AIMD
  • In Vitro Diagnostic Directive 98/79/EC

The 'CE' mark indicates that a product can be marketed in the EU without any trade restrictions.
A ‘CE’ mark may only be affixed on a product after a conformity assessment has been conducted by the manufacturer. Merc supports its customers through all the different steps of this process.

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CE Marking