CE marking

Updated 31 January 2023

Why is CE marking required for medical devices?

CE marking documents that the medical device complies with applicable EU legislation. The purpose of the CE marking is to be able to freely market medical devices in the EU, provided that the devices meet any national requirements (such as registration and language requirements). 

According to the EU regulations on medical devices, such devices are required to bear CE marking when marketed. In this context, marketing means the first time a medical device is made available for distribution or use (for example to a distributor, healthcare professional or patient). This applies regardless of whether the device is new or fully refurbished and independent of whether it is provided free of charge or in return for payment.

According to legislation, custom-made devices, systems and procedure packs and devices intended for clinical testing or performance studies, should not, however, be CE marked.

How to achieve CE marking

To have a medical device CE marked, the device must meet the definition of a medical device and be correctly classified in accordance with the classification rules set out in Annex VIII to the EU regulation on medical devices or in Annex VIII to the EU regulation on in vitro diagnostic medical devices (the IVD regulation). Medical devices are divided into four risk classes: classes I to III for general medical devices and classes A to D for in vitro diagnostic medical devices (IVDs). Class I and class A represent the lowest risk, whereas class III and class D represent the highest risk. For class I and class A devices, the manufacturer is responsible for the CE marking process. Medical devices in higher risk classes must be certified by a notified body.

The role of notified bodies

Notified bodies are designated by the authorities to ensure that manufacturers of medical devices have in place the required technical documentation and quality control for processes and products that involve a serious risk.

Manufacturers are free to choose which notified body for medical devices they want to use.

Technical documentation

Technical documentation must be drawn up based on the general safety and performance requirements set out in Annex I of the regulation on medical devices and the IVD regulation, respectively. The aim is to document the characteristics of the product based on an assessment of the product’s quality, safety and performance.

In addition, the documentation must include a clinical evaluation. A clinical evaluation is an ongoing process in which clinical data from various relevant sources, for example scientific journals and own clinical investigations or performance studies (for IVDs), are analysed and assessed to fully document that the device complies with general safety and performance requirements. The clinical evaluation is to establish that the risks associated with the use of the device are acceptable when weighed against the expected benefits of the device.

The core document of the technical documentation is the risk analysis, which describes the risks associated with the intended use of the medical device. This document must facilitate an assessment of whether the risks associated with the use of the product are acceptable in relation to the benefit achieved by the individual user or patient. The risk analysis must be maintained and updated on an ongoing basis when changes are made which may affect the product’s risk profile (for example production changes and user experience).

Declaration of conformity

Once the safety and performance requirements have been met and the technical documentation has been prepared, the manufacturer must date, sign and keep a declaration of conformity to certify that the product complies with the requirements of the executive order.

The manufacturer must keep the declaration of conformity and the technical documentation available for the Danish Medicines Agency for a period of at least ten years after the last device has been manufactured in the case of non-implantable devices and IVDs; and for a period of at least 15 years in the case of implantable devices. This documentation is not to be submitted to the Danish Medicines Agency, but must be held available to it upon request.

The CE mark

When the manufacturer has signed the declaration of conformity, the device can be CE marked. The CE mark must be affixed visibly, legibly and indelibly on, for example, the instructions for use and symbolises that the product meets the requirements of the legislation.

The CE mark must also be affixed to the sales packaging and the device itself. In the case of a sterile device, the CE mark is placed on the package that keeps the device sterile. In the case of devices involving a notified body, the CE mark must be followed by an identification number of the notified body having assisted in the assessment of the product.

The model for CE marking appears from Annex V of the medical devices regulation.



Learn about self-testing at the website
Testmedfornuft.dk (in Danish)