Laws and rules

Medical devices in Europe must comply with EU legislation. The laws for medical devices are described in the Medical Devices Regulation, the MDR, and must ensure that devices are safe and effective. Before a device can be placed on the market, it must be established that the device complies with the regulation. The CE marking indicates that the device has been developed according to the MDR.

What does CE stand for?

The letters CE stand for "Conformité Européene". This means that the product has been developed by European rules. These rules are described in a European Directive or Regulation. There are Directives for various product groups. The full list of directives and regulations that lead to CE certification is available on the EU website. One of these regulations is the European Regulation (EU) 2017/745 on medical devices, also called the Medical Device Regulation (MDR). Another one is the European Regulation (EU) 2017/746 on in-vitro diagnostic medical devices, also called the In-vitro Diagnostic Medical Device Regulation (IVDR).

The MDR and IVDR contain quality and safety requirements that every medical device must meet. Before a device can be marketed, it must be established that the device meets these requirements. If the device complies, this is indicated by the CE marking (also known as the EC marking or the EC conformity marking). The process of meeting the requirements of the MDR is therefore also referred to as the CE procedure.

Guidance documents provide explanations about certain parts of the MDR, and are published on the website of the European Commission.

CE is not a quality mark

The CE marking is sometimes mistaken for a quality mark. However, there are important differences between CE marking and a quality marking. The main difference is that CE marking is legally required and indicates that the product complies with the law. A quality marking, on the other hand, indicates that the product meets points that have been established by an independent party. However, a quality marking is never legally required.

Exceptions

Exceptions apply to a number of device group, for example single patient devices and clinical research devices.

Other exceptions are devices that will not be traded. This is the case with devices that are developed for one specific patient (custom-made devices) and with devices for clinical investigation. In these cases, there will be no CE marking on the product. However, just like "normal" devices, the device must meet the requirements of the MDR. This tool will not further discuss the CE procedure for these devices. Annex XIII of the MDR defines the procedure for the custom-made devices, Annex XV describes the procedure for the clinical investigation devices.

Responsibility

The person who makes the medical device available on the market under their own name is called the manufacturer. The manufacturer is responsible for the device's compliance with the MDR. Even if the manufacturer does not carry out some actions themselves, such as design, manufacturing, programming or packaging, they are responsible.

If a device has caused damage or injury to a user, the manufacturer can be sued. The manufacturer has an obligation to demonstrate that the device complies with the law.