CE Marking Assessment: The 2026 Reform Is a Game-Changer for the Industry

2026 Reform of Notified Bodies: Front-Line Assessment of CE Marking

The medical device sector is undergoing a period of intense regulatory activity. On May 4, 2026, the European Commission published the Implementing Regulation (EU) 2026/977 , which sets out much more specific guidelines for how notified bodies manage their quotes, timelines, and performance monitoring. Effective as of February 25, 2027, this regulation aims to improve the predictability and efficiency of conformity assessments, while reducing disparities among notified bodies.
Behind these procedural adjustments lies a practical issue: Europe’s ability to evaluate, within a reasonable timeframe, the thousands of devices awaiting market authorization. As of early 2026, the average certification lead time for Class IIb and III devices is 18 to 24 months. 
In 2026, the European survey of notified bodies In fact, it had already reported nearly 32,000 certification applications filed, compared with approximately 12,000 certificates actually issued. This disparity alone illustrates the pressure on the system. 
At the heart of this system lies a demanding and little-known profession: that of the CE marking assessor. It is precisely this role that AFNOR Certification—which recently became a notified body—is now seeking to expand.

CE Marking for Medical Devices: A New Player in a Tight Market

Hip replacements, CT scanners, probes and catheters, breast implants… To serve the medical device (MD) market in Europe, the 2,000-odd French manufacturers in this strategic sector were eagerly awaiting the arrival of a new player capable of evaluating their devices for CE marking. That has now happened, as on April 22, 2024, the French National Agency for Medicines and Health Products Safety (ANSM) and the European Commission authorized AFNOR Certification to issue the coveted certification. In industry jargon, the AFNOR Group subsidiary thus becomes a “notified body.”
This should help reduce the backlog—which is significant in France—since manufacturers have such a hard time quickly finding a national contact to process their marking applications and thus gain access to the European market. The limited number of notified bodies automatically lengthens processing times: the fewer authorized entities there are, the more applications pile up.

The CE marking required for market access and as proof of European compliance

As with thousands of other product families, the CE marking is, in fact, required to market a medical device in the European Union, serving as proof that the product complies with the safety regulations in force (those set forth in Regulations (EU) 2017/745 and 2017/746) within the 27 member states. The procedure is demanding and entails costs for the manufacturer, which are often factored in after clinical trials.
Here, we must distinguish between two things: access to the European market, which requires valid CE marking, and the conformity assessment itself, which is the prerequisite technical and regulatory condition for that access.

"France, which is actually the second-largest market for medical devices in Europe, has had only one notified body to date, compared with 10 in Italy and Germany," explains Thomas Lommatzsch, head of medical services at AFNOR Certification.

This national tension reflects, more broadly, the quality management challenges that permeate the entire healthcare sector.

Which medical products and devices are subject to CE marking?

All medical devices placed on the European market are subject to the CE marking requirement, from a simple bandage to a CT scanner. However, the level of requirements varies depending on the product’s risk class. For devices in the highest-risk classes (implants, active devices, diagnostic products), the involvement of a notified body is mandatory before any product can be placed on the market. This gradation explains why conformity assessment requires very different technical expertise from one product family to another.

CE Standard, CE Mark, CE Logo: The Meaning of the CE Marking

People often refer to “CE standards” or “CE certification,” but these terms are incorrect. The CE marking is not a standard; it is a regulatory symbol that indicates a product’s compliance with European Union requirements. When affixed by the manufacturer, the CE logo means that the product can circulate freely within the European Economic Area. For medical devices, it is based on Regulations (EU) 2017/745 and 2017/746, and not on a single standard (the 'ISO 13485' (which oversees the manufacturer's quality management system).

ISO 13485 and Conformity Assessment: What the Assessor Checks

Within the notified body, the assessor has a dual role: on the one hand, to verify that a medical device complies with the requirements of European regulations, and on the other hand, to verify the effectiveness of the quality management system implemented by the manufacturer, as defined by the ISO standard  ISO 13485 . 
These two aspects should not be confused: regulations establish the regulatory requirements applicable to the product, while ISO 13485 provides a framework for the manufacturer's quality management system.
Familiarity with this quality standard is therefore an important prerequisite for becoming an evaluator, whether you work in this sector as a freelancer or are employed by a manufacturer. In the latter case, you will be required to review marking applications from companies other than your own, for product families different from those you are familiar with. Independence of judgment and the absence of conflicts of interest remain essential requirements.
Specifically, the evaluator reviews the device’s technical documentation, risk management, traceability, supplier control, and post-market vigilance and surveillance systems. The evaluator analyzes nonconformities and assesses their scope. Each assessment also draws on technical expertise specific to the product family being evaluated: an orthopedic implant is not evaluated in the same way as diagnostic software.

To apply for an evaluator assignment, click here: Become an evaluator.

Evaluating medical devices: much more than a checklist

Thomas Trullen, who recently became a certified audit manager and is an expert on ISO 13485, chose to enter this field with the goal of protecting patients: I completed my first year of nursing school before starting medical school. That’s when I realized that abuse was taking place, which really shocked me. That’s why I’m so interested in ensuring that rules are followed. “I don’t conduct audits to be mean or to keep manufacturers from making progress,” he continues, “but to ensure that the processes in place guarantee the products on the market help patients and, therefore, protect them. Sure, reading 250 pages of technical documentation might seem tedious, but your perspective changes once you grasp the underlying human stakes.”

This approach encapsulates the balance required in the profession: neither a mere inspector checking off boxes nor a consultant for the manufacturer. The assessor must be able to justify a finding of non-compliance, understand the context of the audited company, and demonstrate a willingness to educate, all while maintaining independence and adhering to strict ethical standards.
For Chrystel Gary, an engineer by training and a QSE and ISO 13485 auditor, what she likes most about this job is, "It’s about meeting the teams: it’s a rich learning experience and offers a more comprehensive perspective. Because an audit is also about people. The key to its success lies in active listening, empathy, keen observation of those you’re speaking with, and precise questions to understand their approach and the context." The human element remains at the heart of every process. “A good auditor must be highly open-minded and set aside their biases to focus on what they can contribute to those being audited.” , insists Chrystel Gary.

Digital Medical Devices and AI: New Expertise Needs

Another point of interest for auditors who may join the AFNOR Certification team is learning what manufacturers are actually doing to comply with the standard and guidelines. “Sometimes we’re surprised to see that they’ve achieved compliance through processes we hadn’t even considered,” says Thomas Trullen. “This job requires mental agility, curiosity, and the ability to adapt, in addition to knowledge of ethical guidelines. You also need to be a good teacher so that non-conformities are clearly understood.”
Professionals who wish to specialize in CE marking for medical devices can count on AFNOR Certification to guide them toward certification, starting with training. The focus is on devices incorporating artificial intelligence and digital e-health devices—a rapidly growing market in which French startups are particularly innovative and well-positioned. These products raise unprecedented questions regarding cybersecurity and data management, in addition to traditional medical and regulatory requirements: the evaluator must therefore balance three perspectives—medical, digital, and regulatory—and keep their skills up to date as innovation progresses.

CE Marking Assessment: A Field That Has Become Strategic for Europe

At a time when Europe is tightening its regulations to streamline the evaluation of medical devices, the CE marking assessor plays a pivotal role: he or she contributes to patient safety, the trust of healthcare professionals, the quality of devices, and manufacturers’ access to the European market. The role is strategic precisely because it must balance regulatory requirements, technical expertise, and dialogue with teams—without ever compromising the independence that underpins its legitimacy. This is yet another reason for professionals in the sector to consider Become an evaluator.

FAQ - CE Marking 

What is the CE marking for a medical device?

This is the certification that a device complies with applicable European requirements, in particular those set forth in Regulations (EU) 2017/745 and 2017/746. For many devices, it is a prerequisite for marketing within the European Union. The marking is affixed by the manufacturer following a conformity assessment, which involves a notified body depending on the product’s class.

Who assesses the CE conformity of medical devices?

The assessment is conducted by a notified body designated by the competent authorities. In France, AFNOR Certification was authorized to carry out this activity on April 22, 2024. The notified body assesses the product and the quality system, but it is the manufacturer who draws up the EU Declaration of Conformity and affixes the CE marking.

What is the difference between CE marking and “CE certification”?

The term “CE certification” is commonly used, but it is a misnomer. There is no CE certificate issued to a company in the sense of traditional certification: there is a conformity assessment, an EU declaration of conformity drawn up by the manufacturer, and then the affixing of the CE marking. The correct terms are therefore “CE marking” and “conformity assessment.”

How do I become an assessor for the CE marking of medical devices?

Candidates typically need technical or quality expertise in the sector, a solid understanding of ISO 13485, and experience in auditing or evaluation. AFNOR Certification supports candidates through the certification process, including training, while ensuring compliance with the independence and ethical requirements specific to the profession.

How can you tell if a CE marking is genuine?

The CE mark must adhere to specific proportions and, when a notified body has been involved, must be accompanied by its four-digit identification number. Actual compliance is verified through the manufacturer’s EU Declaration of Conformity and, where applicable, the relevant European databases. The mark alone is not sufficient to guarantee a product’s compliance.

How much does CE marking cost?

There is no single fee. The cost depends on the device class, the complexity of the application, the scope of the evaluation, and the associated clinical trials. For devices requiring the involvement of a notified body, this cost is generally factored in by the manufacturer later in the development process. An accurate estimate can only be provided through a quote tailored to the specific device.

How do you verify a CE certification?

Strictly speaking, it is not the “CE marking” that is verified, but rather the product’s compliance. Compliance is verified through the EU Declaration of Conformity issued by the manufacturer and, when a notified body is involved, through its four-digit identification number accompanying the logo. European databases, such as Eudamed for medical devices, allow this information to be cross-checked.

Is the CE marking related to the European Union?

Yes. The CE marking is the “passport” that allows a product to move freely within the European Economic Area. It certifies that the product complies with applicable European safety requirements. Without it, many products—including most medical devices—cannot be marketed in the European Union.