A technical documentation review by a notified body is not random. Assessors follow precise evaluation grids, and certain questions come up in every assessment, whatever the device. Knowing them allows you to build a file that answers the questions before they are asked.
On the clinical evaluation
“How do you demonstrate equivalence with the reference device from a technical, biological and clinical standpoint?” This is the most frequent question for files that rely on a demonstration of equivalence. The assessor checks that all three dimensions are documented specifically, with point-by-point comparative data — not a general statement of similarity.
“Do the available clinical data cover the entire target population and all claimed indications?” Subpopulations (paediatric, geriatric), secondary indications, and use in specific clinical contexts (hospital setting vs outpatient use) are often insufficiently covered in the CERs of SMEs.
“Is the PMCF plan proportionate to the clinical gaps identified in the CER?” The assessor looks for a direct correspondence between the gaps listed in the CER and the activities of the PMCF plan. A PMCF that does not explicitly address the gaps in the CER is sent back for additional information.
On risk management
“Is the list of hazards exhaustive?” The assessor looks for foreseeable risks that may not have been identified: risks linked to foreseeable misuse (not only to correct use), risks linked to environmental conditions, risks linked to interaction with other devices or medicinal products.
“Have the risk control measures been objectively verified under representative conditions?” A risk control measure such as “users will be trained” without data verifying the effectiveness of that training is not acceptable.
On the QMS
“How do you manage significant changes made to your device?” The assessor ensures that a change management procedure is in place and that it provides for a systematic assessment of the impact on the technical documentation and on the certificate.
“How do post-market data feed into your clinical evaluation?” The link between PMS, PMCF and updating of the CER must be documented and traceable. A CER that has not been updated for several years even though post-market data exist is a warning sign.
The method for anticipating these questions
Before submitting a file to an NB, reread each section of the file through the assessor’s eyes: “If I had to explain out loud why this demonstration is sufficient, what would I say?” The sections for which the answer is vague or hesitant are the ones that will generate requests for additional information.