To be marketed in the EU, my medical device, digital or otherwise, must meet generalsafety and performance requirements. These are defined in the European regulations on medical devices, and compliance with these requirements enables me to obtain a certification called CE marking. Obtaining a CE mark is anticipated as early as the development phase of my product. Other European regulations may apply (e.g. RGPD).

Please note: a regulatory transition phase is currently taking place for DM already CE marked under the old European directives. New devices must comply with the European regulations.

Please note: a regulatory transition phase is currently underway for DM already CE marked under the old European directives.

The choice of CE marking scope for your solution is up to you. Ask yourself the following questions: what functionality(s) of my product fall within the definition of a medical device and for what indications?

• It is possible to obtain CE marking for only a "part" of one's solution, i.e. a functionality, a software brick, a sub-system. Collection accessories, the accessories associated with your DM, for example, do not always require marking.
• The system or part of the system that ecomes within the DM definition must obtain CE marking. Other systems or functionalities do not need to obtain marking (for example, anauthentication functionality can be made independent and excluded from the CE marking of a digital DM).

To answer these questions, you need to properly segmentyour business, your software, your infrastructure.

In medical imaging, a digital system has the following functionalities, which do not all have the same purpose and do not all fall within the definition of a DM:

• Production of images subsequently interpreted by doctors, is a DM
• Diagnostic assistance on these images, is a DM
• Storage, archiving of images or the simple communication of data (without analysis on this data), is not a DM

In this case, the image storage and archiving system and the diagnostic support software canbe made independent and interoperable. These devices can then be treated in regulatory terms separately. This means that the diagnostic aid software can obtain its CE mark independently of the imaging system. Thus, a modification to the imaging system does not necessarily impact the CE marking of the diagnostic aid software.

Check out here other examples of software and mobile applications illustrating regulatory positioning.

The assessment of this conformity is carried out by an independent body called a "notified body" (NB), which I choose by ensuring that it is properly designated to carry out conformity assessment activities for this category of medical devices. The use of a NB is subject to a fee, and the European regulation requires that fees 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, it is not necessary to call on a NB, as the regulatory process provides for self-certification. With the exception of Class I DM placed on the market in a sterile state, having a measuring function or reusable surgical instruments, which are also subject to assessment by a NB.

What class for my digital DM? With the implementation of the new European regulations, the vast majority of digital DMs are class 2A or higher, with 80% being class 2A.

The assessment procedures for obtaining CE marking vary according to the risk class of my solution: however, whatever the risk class of my solution, I must prove the performance I claim
. Please note: the higher the risk class of the device, the greater the compliance checks by the NB.

In the vast majority of cases, will be studied:

• The Quality Management System (QMS) which assesses the quality of my company's organization (software design and development, risk management, change management...)
• The technical documentation of my product (the safety and performance of the DM, including ergonomics/usability)

To find out more about choosing the evaluation procedure, go to 1.1.3 of the guide de la HAS

To succeed in my CE marking process, certain areas of expertise in key themes are a must. I need to recruit or be accompanied by external experts concerning:

• Regulatory: it is obligatory (imposed by European regulation) to recruit an expert (with at least 1 year's experience). Beware, this profession is "in short supply", so this recruitment must be anticipated.
• Quality and technical: it is advised to recruit a quality expert or an employee trained in standards (ISO-13485 for example)
• The Clinical: European regulations impose a clinical evaluation of DMs that must be anticipated. It is therefore essential to set up a team competent in these aspects. It can be made up of an internal team member, external experts or a clinical board set up for the clinical development of the product.

I can call on bpifrance's Diagnostic DM window to finance up to 50% of the costs of quality, regulatory and clinical development experts who can support me and train my teams in each of these 3 areas. If I don't know any experts, bpifrance can recommend several who are referenced for this window.

Link to the Guichet Diagnostic action sheet

• I set up a QMSwhich describes allthe processes associated with the production of my DMand its compliance with CE marking requirements (change management, risk management, deployment management, production releases, etc.)
• Based on my QMS, I build my technical documentation which proves that my product meets the safety and performance requirements of this same regulation.

Sufficiently in advance of my conformity assessment request to the NB that has agreed to take charge of this assessment, I must specify the level of clinical evidence needed to demonstrate my solution's compliance with the requirements of the European regulation. As a result, I plan, carry out and document a clinical evaluation.

The scope of the clinical evaluation depends on the risk class of the device.

At this stage, I need to anticipate my business model and anticipate the clinical evidence I will need to obtain reimbursement from national solidarity if my product is eligible for reimbursement as such. Note that the clinical evaluation carried out for CE marking is not, however, sufficient to obtain reimbursement by the Assurance Maladie.