CE marking assessor for medical devices, a strategic job
Hip prostheses, scanners, probes and catheters, breast implants… To serve the medical devices (MD) market in Europe, the 2,000 or so French manufacturers in this strategic sector were impatiently awaiting the arrival of a new player who could affix the CE mark to their equipment. On 22 April 2024, the French National Agency for the Safety of Medicines and Health Products (ANSM) and the European Commission authorised AFNOR Certification to issue the precious seal of approval. In the jargon, the AFNOR Group subsidiary thus becomes a ‘notified body’.
A new player in a market under pressure
This should help to clear the long waiting list in France, where manufacturers are finding it so difficult to quickly find a national contact to process their marking applications and open the door to the European market. As is the case for thousands of other product families, CE marking is in fact required to market a medical device in the EU, providing proof that the product complies with the safety rules in force (those in regulations 2017/745 and 746) within the EU-27. The procedure is demanding and represents a cost for the manufacturer, often integrated downstream of the clinical trials. ‘Despite being Europe’s second-largest medical device market, France has until now had only one notified body, compared with 10 in Italy and Germany,’ explains Thomas Lommatzsch, head of AFNOR Certification’s medical offering.
The company comes to the market with a team of highly specialised experts who are keen to expand. Their mission: to verify both the conformity of a medical device with the requirements of the regulation, and the effectiveness of the quality management system put in place by the manufacturer, as defined by the ISO 13485 standard. Knowledge of this quality standard is therefore an important prerequisite for becoming an assessor, whether you work in this sector as an independent assessor or for a manufacturer. In the latter case, you will be required to examine marking applications other than those submitted by your company, for product families other than those with which you are familiar.
Evaluating DMs: much more than a list of checkboxes
Thomas Trullen, recently certified as an audit manager and an expert in ISO 13485, chose to enter this sector with patient protection in mind: “I did my first year in nursing school before studying medicine. At the time, I noticed that there was a lot of mistreatment, which really upset me. Hence my interest in compliance. I don’t audit to be mean and stop the manufacturer going round in circles,” he continues, ”but to ensure that the processes are such that the products on offer help the patient and therefore protect him or her. Admittedly, reading 250 pages of technical documentation may seem daunting, but your perspective changes when you grasp the underlying human issues.”
For Chrystel Gary, who trained as an engineer and now works as a QSE and ISO 13485 auditor, what she likes most about her job is “meeting the teams: it’s rich in experience and offers a more global vision. Because auditing is also about people. The key to success: active listening, empathy, keen observation of your contacts and precise questioning to understand their approach and context”. The human side remains at the heart of every approach. “A good auditor needs to be very open-minded, and eliminate prejudices in order to concentrate on what they can bring to the auditee”, insists Chrystel Gary.
AI-enabled medical devices, a market of the future
Another point of interest for the auditors who join the AFNOR Certification team for CE marking: finding out what manufacturers actually do to comply with the standard and reference documents. Sometimes, we’re surprised to see that they’ve managed to do it using processes we hadn’t even thought of,” comments Thomas Trullen. This job requires intellectual gymnastics, curiosity and the ability to adapt, as well as knowledge of ethical rules. You also need to be an educator, so that any points of non-compliance are clearly understood.
Professionals wishing to specialize in the CE marking of medical devices can count on AFNOR Certification’s support to lead them to qualification, by way of training. With a focus on medical devices incorporating artificial intelligence and digital e-health devices, this is a booming market in which French start-ups are particularly innovative and well placed.
