CE MARKING FOR MEDICAL DEVICES
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CE Marking For Medical Devices

When your product is a medical device in accordance with the Medical Device Directive 93/42/EEC or the Medical Device Regulation (EU) 2017/745, it is legally obliged that they bear the CE mark.

The procedure to CE mark your medical device goes beyond only affixing the CE mark onto your product. In order to affix the CE mark on your medical device the legal manufacturer of the medical device shall ensure that it complies to the requirements indicated in the aforementioned Directive or the Regulation. The legal manufacturer shall ensure compliance by carrying out the required conformity assessment procedure. This procedure consists of both Technical Documentation requirements as well as quality management system requirements. For medical devices higher than Class I involvement of a third party, a Notified Body, is required. The Notified Body will then assess the quality management system as well as the Technical Documentation.

The experts of CE Medical can fully guide your company through the conformity assessment procedure which enables compliance of your medical device with the Medical Device Directive 93/42/EEC or the Medical Device Regulation (EU) 2017/745. The guidance comprises of:

  • Classification of the medical device.
  • Determining the correct conformity assessment procedure.
  • Evaluating the available Technical Documentation.
  • Guidance to draw up and complete the Technical Documentation.
  • Evaluating the available quality management system.
  • Guidance to implement a quality management system in accordance with the legislation.
  • Correspondence with the Notified Body.

Contact one of our experts now to discuss the CE marking of your medical device.

 

CE Marking Medical Devices

Contact one of our experts now to discuss the possibilities regarding CE-marking for your medical device

 

CE Marking Medical Devices