Free movement of medical devices/in vitro diagnostic medical devices

Only medical devices/in vitro diagnostic medical devices bearing the European conformity CE marking may be placed on the market or put into service; the marking signifies that these devices have been subject to conformity assessment with one of the following European regulations:
REGULATION (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR)
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices

As a general rule, devices should bear the CE marking to indicate that they comply with this Regulation (MDR/IVDR) so that they can move freely within the Union and be put into service in accordance with their intended purpose.

A ‘CE conformity marking’ or ‘CE marking’ means a marking by which a manufacturer indicates that a device is compliant with the applicable requirements set out in the Regulation and with other applicable Union legislation for harmonisation providing for its application.

The CE marking must be affixed visibly, legibly and indelibly to the product or to its sterile packaging, where possible, and to the instructions for use. The CE marking must also be affixed to the packaging in which the device is marketed.

The CE marking must be affixed before the product subject to it is placed on the market. It may be followed by a pictogram or any other marking indicating a special risk or use.

Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for the conformity assessment procedures. The identification number shall also be indicated in any promotional material which mentions that a device meets the requirements relating to the CE marking.

Custom-made medical devices and those intended for clinical investigations are exempted, they do not need to bear the CE marking.

Systems and procedure packs do not need to bear an additional CE marking.

Given the fact that users, especially healthcare providers, must only use medical devices/in vitro diagnostic medical devices which meet the applicable legal provisions, they must be aware of the legislation regarding these devices.

In order to ensure compliance of medical devices with applicable requirements as well as their placing on the market according to the law, healthcare providers must request the manufacturer for compliance documents (the EC declaration of conformity and the conformity assessment certificate, as applicable).

To prevent potential issues related to the quality/performance of medical devices used without the intervention of a specialist, users should pay attention to the existence of the CE conformity marking when purchasing medical devices/in vitro diagnostic medical devices.