Legal requirements for manufacturer placing medical devices on the market

Medical Device CE Marking

As a manufacturer of medical devices it is required to demonstrate that your medical device meets the requirements in the Medical Devices Directive (MDD) by carrying out a conformity assessment. The conformity assessment route depends on the classification of the device.

The classification of the device in the appropriate class is the first critical activity that a manufacturer needs to complete to identify the device category and applicable rule as outlined in the MDD. The legal manufacturer will have to pass the conformity assessment based on the classification of their device, before being able to place a CE mark on their product to show that the medical device has met the essential requirements.