To be marketed in the EU, your medical device, whether digital or not, must meet general safety and performance requirements. These requirements are defined in the European regulations relating to medical devices, and compliance with them makes it possible to obtain a certification called CE marking. Obtaining CE marking is something you need to plan for starting in the development phase of your product. Other European regulations may apply (e.g. GPDR).

Note: A regulatory transition phase is currently underway for medical devices already CE marked under the old European directives. The new devices must comply with European regulations.

It is up to you to choose the scope of your solution’s CE marking. Ask yourself the following questions: Which of your product's features fall under the definition of a medical device, and for what indications of use?

• It is possible to obtain CE marking for only "part" of one's solution, i.e. a feature, a software brick, or a subsystem. Collection accessories, and accessories associated with your device, for example, do not always need to be marked.
• The system to be CE-marked must fall within the definition of a medical device. Other systems or features do not need to be marked (e.g. an authentication feature can be made independent and excluded from the CE marking of a digital medical device).

To answer these questions, you must properly segment your company, your software, and your infrastructure.

In medical imaging, a digital system has the following features, which do not have the same purpose and do not all fall under the definition of a medical device:

• Producing images interpreted by doctors is a medical device
• Diagnostic support for these images is a medical device
• Image storage (PACS) is not a medical device

In this case, the storage system (PACS) and the diagnostic support software can be made independent and interoperable. The regulatory matters of these devices can then be dealt with separately. This means that diagnostic support software can obtain its CE marking independently of the imaging system. Thus, a modification to the imaging system does not necessarily impact the CE marking of the diagnostic software.

The assessment of this conformity is carried out by an independent organization called a "notified body" (NB), which you choose on your own, making sure that it is designated to carry out conformity assessment activities for this category of medical device. The use of a NB is subject to a fee, and European regulations requires that the rates be available for consultation by manufacturers. It is possible to use a foreign NB from the European Union.

Please note: For Class I medical devices, there is no need for a NB, the regulatory process entails self-certification. The exception is Class I medical devices placed on the market in a sterile state, with a measuring function or reusable surgical instruments, which are also subject to assessment by a NB.

Which class is your digital medical device in? With the implementation of new European regulations, the vast majority of digital medical devices are class 2A or higher, 80% are class 2A.

The evaluation procedures for obtaining CE marking vary based on the risk class of your solution; however, whatever its risk class, you must prove the performance that you claim
Please note: The higher the risk class of the device, the more exacting the compliance checks by the NB will be.

In the vast majority of cases, the following will be examined:

• The Quality Management System (QMS) which evaluates how well your company is organized (design and development of the software, risk management, change management, etc.)
• Your product’s technical documentation (safety and performance of the medical device, including ergonomics/usability)

For more information on the choice of evaluation procedure, go to 1.1.3 of the HAS guide

To succeed in your CE marking process, certain expertise in key areas is essential. You need to hire or be accompanied by external experts regarding:

• Regulations: It is mandatory (under European regulations) to recruit an expert (with at least 1 year experience). Note that there is a tight labor market for this position, so it must be planned in advance.
• Quality and technique: It is recommended to recruit a quality expert or an employee trained in standards (ISO-13485 for example)
• Clinical: European regulations require a clinical evaluation of medical devices, which must be planned for. It is therefore essential to set up a competent team for these matters. It can be composed of an internal team member, external experts or a clinical board formed for the clinical development of the product.

• Set up a QMS which describes all the processes associated with the production of your medical device and its compliance with the requirements of CE marking (change management, risk management, deployment and release management, etc.)
• Based on your QMS, build your technical documentation which proves that your product meets the safety and performance requirements of that same regulation

Well enough in advance of your request for conformity assessment to the NB that has agreed to do the assessment, you must specify the level of clinical evidence necessary to demonstrate the compliance of your solution with the requirements of European regulations. Therefore, you should plan, conduct, and document a clinical assessment.

The extent of the clinical assessment depends on the risk class of the device.

At this stage, you must anticipate your business model and the clinical evidence that will be required to obtain reimbursement from the national health insurance system if your product is eligible for such reimbursement. Please note that the clinical assessment carried out for CE marking is not sufficient to obtain reimbursement by the national Health Insurance Fund.