To be able to bring a medical device to market within the European Economic Area (EEA) and the countries that have a collaboration agreement with the EEA, the manufacturer must undergo the legal procedure for CE marking. Custom-made devices, systems and treatment packages, medical devices for clinical research and IVDs intended for performance studies are exceptions to this and do not need to bear CE marking.
For most medical devices, the application of this CE marking must first be approved by a notified body.
A notified body is a private organization that is designated and registered by the competent authorities of the member states. In Belgium, notified bodies are designated by the FAMHP and registered by BELNANDO. Then the notified body is registered with the European Commission. 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 and on the device, followed by four numbers that refer to the notified body. On the website of the European Commission you can see the institutions consistent with these four numbers.
The CE marking applied to a medical device guarantees that the essential requirements are met and thus that the performance, safety and benefits of the medical device have been considered proven for the circumstances of use intended by the manufacturer.
Custom-made medical devices that do not bear a CE mark, and all systems and treatment packages are marketed with notification to the FAMHP.
For medical devices of class I and some IVDs, the manufacturer is the only body responsible for the quality, safety and efficacy of the product. The product is marketed using a notification to the FAMHP and by a self-certification that is recognizable by the CE-marking without four digit code.
Another specific case are medical devices in class I which are sold sterile and/or with a measurement function and class I reusable surgical instrument. The maintenance of sterility and the measurement function must be checked by a notified body.
Reusable surgical instruments must be assessed by a notified body with regard to aspects related to the reuse of the device, in particular cleaning, disinfection, sterilization, maintenance and functional testing and the related instructions for use.
This means that the CE-marking on these types of medical devices are also followed by the four digit code.
There are two exceptions:
- For a clinical study with medical devices or a performance study with IVDS, it is possible that the manufacturer wants to extend the use of its medical device to other indications and this means that the performance and clinical benefit of the known device must be proven again for this new indication.
- In the case of a derogation to the CE marking (according to the art. 59 of the regulation 2017/745), this deviation is permitted by the minister of public health for a certain patient and under certain conditions. It must also be shown that there are no real therapeutic alternatives to treat the affected patient.
The CE-marking must be visibly, legibly and unmistakeably printed on the medical device as far as is technically possible, and on the instructions for use and the commercial packaging.
For systems and treatment packages, the assembly of the medical device must bear a CE-marking. If this assembly occurs with unmarked devices, this marking must be applied to the assembly considered a medical device.