Evaluator for CE marking of medical devices, a strategic profession

Hip replacements, scanners, probes and catheters, breast implants... To serve the medical device (MD) market in Europe, the 2,000 or so French manufacturers in this strategic sector were eagerly awaiting the arrival of a new player who could affix the CE marking to their devices. This has now been achieved, 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 mark. In technical terms, the AFNOR group subsidiary has thus become a "notified body."

A new player in a tense market

This will help reduce the long waiting list in France, where manufacturers struggle to find a national contact to process their marking applications and open the door to the European market. As with thousands of other product families, CE marking is required to market a medical device in the EU, providing proof that the product complies with the safety rules in force (those of Regulations 2017/745 and 746) within the EU-27. The procedure is demanding and represents a cost for the manufacturer, often integrated downstream of clinical trials. "France, which is 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.

The company operates in the market with a team of highly skilled experts who are eager to grow. Their mission is to verify both the compliance of medical devices with regulatory requirements and the effectiveness of the quality management system implemented by the manufacturer, in accordance with ISO 13485. Knowledge of this quality standard is therefore an important prerequisite for becoming an assessor, whether you work in this sector as a freelancer or for a manufacturer. In the latter case, you will be required to examine marking applications other than those from your own company, for product families other than those you are familiar with.

Evaluating medical devices: much more than a checklist

Thomas Trullen, recently certified as an audit manager and an expert in ISO 13485, chose to work in this sector with a focus on patient safety: "I spent my first year at nursing school before starting medical school. I then noticed that there was abuse, which shocked me greatly. That's why I'm interested in compliance with the rules.  I don't audit to be mean and prevent manufacturers from doing their job," he continues, "but to ensure that the processes in place mean that the products offered help patients and therefore protect them. Of course, reading 250 pages of technical documentation may seem daunting, but you change your perspective when you understand the underlying human issues at stake."

For Chrystel Gary, who trained as an engineer and QSE and ISO 13485 auditor, what she likes most about her job is "meeting the teams: it's a rich experience and gives you a more global perspective. Because auditing is also about people. The key to her success: active listening, empathy, keen observation of her interlocutors, and precise questions to understand their approach and context." The human aspect remains at the heart of every approach. "A good auditor must be very open-minded and set aside their prejudices in order to focus on what they can bring to the auditees," insists Chrystel Gary.

Medical devices equipped with AI: a market with a promising future

Another point of interest for auditors joining the AFNOR Certification team for CE marking is discovering what manufacturers are actually doing to comply with the standard and reference systems. "Sometimes we are surprised to see that they have achieved this through processes we hadn't thought of," comments Thomas Trullen. "This job requires mental agility, curiosity, and adaptability, in addition to knowledge of ethical rules. You also need to be a good teacher so that points of non-compliance are clearly understood."

Professionals who wish to specialize in CE marking for medical devices can count on AFNOR Certification to guide them through the qualification process, including training. The focus is on medical devices incorporating artificial intelligence and digital e-health devices, a booming market in which French start-ups are particularly innovative and well positioned.