Choosing a notified body is a strategic decision that many manufacturers treat as an administrative step. They compare prices, pick the cheapest or the geographically nearest one, and then discover that the selected notified body is not designated for their type of device, has an 18-month backlog, or works exclusively in English with teams unfamiliar with the French market.
The most common selection mistakes
Mistake 1: failing to check the scope of designation. Each notified body is designated for specific categories of devices, identified by codes in the NANDO database. A notified body designated for orthopaedic implants is not necessarily designated for medical software or in vitro diagnostic devices. Checking the designation in NANDO before any contact is the first, non-negotiable step.
Mistake 2: failing to ask for the real timelines. The timelines advertised on notified bodies’ websites do not always match the actual review timelines. A notified body may advertise “6 to 9 months” on its website while in fact having an 18-month queue. You must ask explicitly: “What is your current timeline for the initial review of a class IIa file, from submission to issuance of the certificate?”
Mistake 3: choosing on price alone. Notified body fees are comparable between providers of the same level. An offer that is significantly lower should prompt the question: what is not included? Review of the clinical file by a senior expert costs more than a review by a junior. The two do not produce the same level of examination.
Mistake 4: ignoring the contractual relationship. The contract with the notified body commits you for 5 years. The termination conditions, the arrangements for transferring certification in the event of a change of notified body, the procedure for handling non-conformities, and the guaranteed response times are clauses that matter. Failing to read them before signing is a common mistake.
Mistake 5: failing to assess linguistic and cultural compatibility. For a French SME whose regulatory team works mainly in French, a notified body whose every communication and every review exchange takes place in English creates permanent friction that lengthens timelines and increases the risk of misunderstanding on technical points.
Timelines in 2024: a reality you must factor in
Review timelines for the first MDR files remain long in 2024, even though the situation has gradually improved compared with the years 2021-2022. For a first class IIa file, allowing 9 to 15 months between submission and issuance of the certificate is realistic. For class IIb, 12 to 24 months. These timelines assume a file submitted complete and of high quality — a file with significant gaps will return to the back of the queue after each cycle of requests for additional information.