To be marketed in the EU, my medical device, whether digital or not, must meet general safety and performance requirements. These are defined in European regulations on medical devices, and compliance with these requirements allows me to obtain a certification called CE marking. Obtaining CE marking must be anticipated from the development phase of my product. Other European legislation may also apply (e.g., GDPR).

Please note: a regulatory transition phase is currently underway for MDs that already have CE marking under the old European directives. New devices must comply with European regulations.

The choice of the scope of the CE marking for your solution is yours. Ask yourself the following questions: Which feature(s) of my product fall within the definition of a medical device and for which indications? 

• It is possible to obtain CE marking for only a "part" of your solution, i.e., a feature, a software component, or a subsystem. For example, collection accessories and accessories associated with your MD do not always require marking.
• The system or part of the system that falls within the definition of a MD must obtain CE marking. Other systems or functionalities do not need to obtain marking (for example, an authentication functionality can be made independent and excluded from the CE marking of a digital MD). 

To answer these questions, you must carefully segment your business, your software, and your infrastructure.

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

• Production of images that are then interpreted by doctors is a medical device
• Diagnostic assistance based on these images is a medical device
• Storage, archiving of images, or simple communication of data (without analysis of this data) is not a MD

In this case, the image storage and archiving system and the diagnostic assistance software can be made independent and interoperable. These devices can then be treated separately for regulatory purposes. This means that the diagnostic assistance 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.

See here for other examples of software and mobile applications illustrating the regulatory positioning.

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

What class does my digital MD belong to? With the implementation of the new European regulations, the vast majority of digital MDs are class 2A or higher, with 80% being class 2A.

The assessment procedures for obtaining CE marking vary depending on the risk class of my solution: however, regardless of the risk class of my solution, I must prove the performance I claim.
Note: The higher the risk class of the device, the more stringent the conformity checks by the NB.

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

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

For more information on choosing the assessment procedure, see section 1.1.3 of the HAS guide.

To successfully obtain CE marking, certain expertise in key areas is essential. I need to recruit or be supported by external experts in the following areas:

• Regulatory matters: it is mandatory (required by European regulations) to recruit an expert (with at least one year of experience). Please note that this profession is in high demand, so recruitment must be planned in advance.
• Quality and technology: it is advisable 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 in advance. It is therefore essential to put together a team with expertise in these areas. This team may consist 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 Medical Device Diagnostics service to finance up to 50% of the costs of quality, regulatory, and clinical development experts who can assist me and train my teams in each of these three areas. If I don't know any experts, bpifrance can recommend several who are referenced for this service.

Link to the Diagnostic Desk fact sheet

• I am implementing a QMS that describes all the processes associated with the production of my MD and its compliance with CE marking requirements (change management, risk management, deployment management, production launches, etc.). 
• Based on my QMS, I am compiling technical documentation that proves that my product complies with the safety and performance requirements of this same regulation. 

Well in advance of my request for conformity assessment to the NB, which has agreed to carry out this assessment, I must specify the level of clinical evidence required to demonstrate that my solution complies with the requirements of the European regulation. I therefore 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 must anticipate my business model and the clinical evidence I will need to obtain reimbursement from the national health insurance system if my product is eligible for coverage as such. It should be noted, however, that the clinical evaluation carried out for CE marking is not sufficient to obtain coverage by the Health Insurance system.