Medical devices must be CE marked before they can be placed on the market.
CE marking shows that the device complies with the legislation for medical devices. In order to CE mark a medical device, the manufacturer must be able to document the quality, safety and performance of the device. This documentation must be available to the Danish Medicines Agency at all times.
According to legislation, measurement, system and treatment packages as well as equipment for clinical testing do not require CE marking. However, such products may be required to obtain other forms of certification or to meet specific marking requirements. Read more on the website of the Danish Medicines Agency under CE marking.
The Four Risk Classes
As medical devices are used on patients, they must be safe to use. CE marking of medical devices has been grouped into four risk classes:
- Class 1/I
- Class 2a/IIa
- Class 2b/IIb
- Class 3/III
A class 1 device has the lowest risk, while class 3 products have the highest risk. A class 1 device could be a zimmer frame, whereas breast implants are class 3 devices.
Certifying the Safety of the Device
If a medical device is in a higher risk class than class I, then a so-called notified body must assess the product documentation.
A notified body is a private organisation which has been authorised by the national health authorities to assess the documentation and determine whether it meets the legal requirements. If the requirements are met, the notified body will issue a certificate which forms part of the manufacturer’s documentation of the safety of the device.
New EU Rules
In May 2017, the European Parliament adopted a new set of rules in this area. The so-called Medical Device Regulations (MDR) will be implemented over a three-year period. All information on this page applies both to the previous and new regulations.