To be able to place a medical device or an IVD on the market within the European Economic Area (EEA) and the countries that have a collaboration agreement with the EEA, the manufacturer must apply the legal procedure for CE marking. The CE marking applied to a device guarantees that the essential requirements of the applicable legislation are met and thus that the performance, safety and benefits of the device have been considered proven for the circumstances of use intended by the manufacturer. The CE-marking must be visibly, legibly and indelibly on the device as far as is technically possible, and in any instructions for use and on any sales packaging.
Regarding CE marking, three possibilities exist:
1. The CE marking is approved by a notified body
For most medical devices and IVDs, the application of the CE marking must first be approved by a notified body. A notified body is a private organisation that is designated and registered by the competent authorities of the member states. In Belgium, notified bodies are designated by the FAMHP. Before being designated, the body must meet certain requirements regarding knowledge, experience, independence and resources to perform conformity assessments.
Once the manufacturer has been certified by a notified body, they may apply CE marking to the packaging, on the device and in the instructions for use, followed by four numbers that refer to the notified body. On the website of the European Commission you can find which notified body corresponds to these four numbers.
2. The CE marking does not have to be approved by a notified body
For some medical devices and IVDs that belong to the lowest risk classes, no prior notified body approval is needed for CE marking. This applies to class I medical devices of and class A IVDs. The manufacturer is the only body responsible for the quality, safety and efficacy of the product. The device is placed on the market by a self-certification by the manufacturer. These devices are thus recognizable by the CE-marking without the four digit code of a notified body.
An exception to this are medical devices in class I which are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments and also IVDs of class A that are sterile. In those cases, the notified body must check the following aspects:
- the aspects relating to establishing, securing and maintaining sterile conditinos for class I sterile medical devices and class A sterile IVDs;
- the aspects relatinf to the conformity of the devices with the metrological for devices which have a measuring function;
- the aspects relating to the reuse of the device, in particular cleaning, disinfection, sterilisation, maintenance and functional testing and the related instructions for use for reusable surigcal instruments.
This means that the CE marking on these types of medical devices and IVDs is also followed by the four digit code of a notified body.
3. Medical devices and IVDs without CE marking
- Custom-made devices, systems and procedure packs, medical devices for clinical studies and IVDs for performance studies do not need to bear CE marking. Custom-made medical devices are placed on the market by a self-certification by the manufacturer (however, for class III custom-made implantable devices, an approval by a notfied body is required despite the absence of CE marking). Systems and procedure packs are placed on the market by a self-certification by the assembler.
An exception are: (i) systems and procedure packs that incorporate devices which do not bear the CE marking or where the chosen combination of devices is not compatible in view of their original intended purpose, or where the sterilisation has not been carried out in accordance with the manufacturer's instructions. In that case, a CE marking needs to be applied to the assembly that is itself considered a medical device. (ii) As regard clinical studies with medical devices or performance studies with IVDs, it is possible that the manufacturer wants to extend the use of its medical device or IVD to other indications and this means that the performance and clinical benefit of the known device must be proven again for this new indication. These studies are thus performed with devices that already bear CE marking.
- In some circumstances and under specific conditions, the minister of public health or his delegate can allow the placing on the market of a device without CE marking (according to the art. 59 of regulation 2017/745 or art. 54 of regulation 2017/746). It must be demonstrated, among other things, that there are no real therapeutic alternatives to treat the patient(s) concerned.