Only CE marked medical devices can be placed on the market. The CE mark shows that the device meets the legal requirements for medical devices. To place a CE mark on a medical device, the manufacturer must document the product's quality, safety and performance.
Why do medical devices have to be CE marked?
The CE marking shows that medical devices meet the current EU legislation. The CE marking means that medical devices can be marketed in the EU, provided that the devices meet the national requirements (e.g. regarding registration and language requirements)
The executive order on medical devices stipulates that a medical device must bear a CE mark before it can be placed on the market. In this context, marketing refers to the first time a medical device is made available for distribution or use (e.g. to a distributor, healthcare professional or patient). This applies whether the device is new or recently refurbished and whether it is provided with or without charge.
However, there is no legal requirement for CE marking of custom-made devices, system and medical treatment packages and devices for clinical investigation.
How to place a CE marking on a product
Before placing a CE marking on a medical device, the device must be covered by the definition of medical devices and be classified correctly in accordance with the classification rules laid down in annex IX of the executive order on medical devices. Medical devices are divided into four risk classes: I (Im, Is), IIa, IIb and III. Class I is associated with the lowest risk, while class III is associated with the highest risk. The manufacturer of a class I device is responsible for the CE marking process. A notified body must be involved in the certification of medical devices belonging to higher risk classes.
The notified body
Notified bodies are authorised by the authorities to ensure that manufacturers of medical devices have the required technical documentation and perform quality control for processes and products that may pose a significant risk.
A notified body must be involved before marketing any medical devices, with the exception of class I devices that do not include sterile products or a measuring function, custom-made devices as well as in vitro diagnostic devices that are not covered by annex II.
Manufacturers can choose which notified body they want to involve in the certification process.
The technical documentation should be established based on the essential requirements as to safety and performance, see annex I of the three executive orders on medical devices. The purpose is to document the properties of the product based on an evaluation of the product's quality, safety and performance.
In addition, the documentation must comprise a clinical evaluation. A clinical evaluation is an ongoing process in which clinical data from different relevant sources, e.g. scientific journals and own clinical investigations, are analysed and assessed to document that the device complies with the essential requirements as to safety and performance. The clinical evaluation must provide evidence that the risks associated with using the device are acceptable in relation to the benefits of using the device.
The risk analysis is the central document of the technical documentation. It describes the risk elements associated with the intended use of the device. The document is a means to assess whether the risks associated with using the product are acceptable in relation to the benefits for the individual user or patient. The risk analysis must be regularly maintained and updated in case of changes that may affect the product's risk profile (e.g. production changes and user experiences).
When the product is in compliance with the requirements for safety and performance, and the technical documentation has been established, the manufacturer must date, sign and keep a declaration of conformity to show that the product complies with the requirements of the executive order.
The manufacturer is required to have the declaration of conformity and the technical documentation available at any time to the Danish Medicines Agency for at least five years after discontinuation of the manufacture of the product for non-implantable devices and in vitro diagnostic devices, and at least 15 years for implantable medical devices. The documentation should not be submitted to the Danish Medicines Agency, but be available on request.
Once the manufacturer has signed the EU declaration of conformity, the CE mark can be placed on the device. The CE mark should be placed visibly, legibly and indelibly on the instructions for use and is a symbol that the product complies with the legal requirements.
The CE mark must also be affixed to the packaging and on the device. On sterile devices, the CE mark should be placed on the package that ensures sterility of the device. The identification number for a notified body has to be placed below the CE mark.
The CE mark is shown in annex XII of the executive orders on medical devices.