CE marking for medical devices

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CE marking for medical devices

In order to be allowed for marketing a medical device in Europe, it is necessary to demonstrate its compliance with the new Regulations relating to medical devices (CE marking for medical devices).

Since May 2017 two new Regulations enter into force in:

  • Regulation 2017/745 on Medical Devices,
  • Regulation 2017/746 on in vitro diagnostic medical devices.

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