The number of notified bodies (NBs) designated under Regulation (EU) 2017/745 is growing, but remains structurally insufficient relative to demand. For a medical device manufacturer preparing or renewing a certification, the question is no longer “are there enough NBs?” but “which NB, in what timeframe, for my type of device?”.
How many NBs are designated under the MDR mid-2026?
In January 2024, the NANDO database listed 43 NBs designated under the MDR. In October 2025, the designation of NOTICE (Slovenia) brought the total to 51. Mid-2026, the figure stabilises at around fifty active NBs.
By way of comparison, roughly 80 NBs operated under Directive 93/42/EEC. Overall file-review capacity therefore remains more than a third below what it was before the MDR took effect in May 2021.
Each NB is designated for specific device categories, identified by the codes in Implementing Regulation (EU) 2017/2185. An NB designated for active non-implantable devices and an NB designated for orthopaedic implants are not interchangeable. The scope of designation is the first piece of information to check before making any contact.
The only reliable source for this verification is the European Commission’s NANDO database, now hosted on the Single Market Compliance Space platform. Any list published in an article, including this one, may be out of date by the time you read it.
Two NBs in France: GMED and AFNOR Certification
France has two NBs designated under the MDR, both under the oversight of the ANSM.
GMED (NB 0459), historically the only French NB under Directive 93/42/EEC, was among the first designated under the MDR. Its scope of designation covers a broad range of device categories.
AFNOR Certification (NB 0333) obtained its designation on 23 April 2024. This is notable: AFNOR Certification was not an NB under the previous directives. Its designation was built from scratch, with a file submitted to the ANSM as early as 2020 and a joint assessment process lasting three and a half years. Its initial scope covers active and non-active non-implantable devices. Implantable devices were deliberately excluded at first, to concentrate resources.
For French manufacturers, having two NBs on national territory eases the logistical side (on-site audits, working language), but does not remove the need to check the compatibility of the scope of designation with the device concerned.
IVDR: an even tighter situation
On the in vitro diagnostic side, the situation is markedly more constrained. Around a dozen NBs are designated under Regulation (EU) 2017/746 mid-2026. That is insufficient given the volume of devices concerned: under Directive 98/79/EC, most IVDs did not require the involvement of an NB. Under the IVDR, classes B, C and D are subject to it.
IVD manufacturers must plan earlier and more aggressively than MDR device manufacturers. The transitional deadlines are staggered: May 2025 for class D, May 2026 for class C, May 2027 for class B and sterile class A IVDs. Regulation (EU) 2024/1860 formalised these amended deadlines, but NB review timelines do not compress by decree.
Real review timelines: what we observe
The timelines shown on NB websites are rarely up to date. What we see in the field mid-2026:
For a complete class IIa file submitted to an NB with available intake capacity, the timelines between submission and issuance of the certificate range from 6 to 18 months. The range is wide because it depends on three factors that the manufacturer partly controls: the quality of the file at submission, the clinical complexity of the device, and the number of question/answer iterations with the NB.
For classes IIb and III, timelines are systematically longer. Clinical evaluation, post-market clinical follow-up documentation (PMCF), and the review of the risk management system add further review cycles.
An incomplete or technically weak file lengthens timelines disproportionately. The NB does not “make up for” a poorly prepared file: it asks questions, waits for answers, reassesses. Each cycle can add two to four months.
How to choose and contact an NB
Contacting several NBs in parallel is not rudeness, it is an operational necessity. The approach must be structured.
Check the scope of designation in NANDO for each NB considered. Identify the MDA/MDN/MDS/MDT codes matching the device. Prepare a concise description of the device: risk class, intended purpose, technology, state of progress of the technical file. Explicitly request the estimated timeline between submission of a complete file and issuance of the certificate, as well as the availability of audit slots.
The intake capacity of NBs varies with the time of year and the type of device. An NB may have three months’ availability for an active non-implantable device and a twelve-month queue for an implant. Answers obtained in January no longer hold in June.
One point many manufacturers overlook: choosing an NB is also choosing a working relationship over five years (the validity period of an MDR certificate, with annual surveillance audits and at least one unannounced audit per cycle). Technical, linguistic and logistical compatibility matter as much as the initial timeline.
What is changing on the NB regulation side
In December 2025, the European Commission published a draft implementing regulation aimed at harmonising NB practices under the MDR and IVDR. This text clarifies the requirements of Annex VII on quotation procedures, conformity assessment timelines and recertification processes. The aim is to reduce practice gaps between NBs and improve predictability for manufacturers.
Since May 2026, the “Notified bodies and certificates” module of EUDAMED is mandatory. NBs must register in it any information relating to certificates issued, suspended, withdrawn or refused. For manufacturers, this means greater public traceability of the status of their certificates.
In October 2024, the European Parliament adopted a resolution on the urgency of revising the MDR, explicitly identifying NB capacity as a limiting factor. The Commission’s reform proposal (December 2025) provides, among other things, for a move to periodic risk-based review rather than a fixed five-year recertification cycle. This text has not yet been adopted mid-2026, but it indicates the direction of travel.
Anticipate, don’t endure
The manufacturer who waits until the technical file is finalised before contacting an NB runs the risk of a 12- to 18-month shift in its market-launch roadmap. Contacting the NB must be built into the development schedule from the design phase, not at the end.
Your certification schedule depends on a solid technical file, an operational QMS and a conformity assessment strategy aligned with your risk class. If you are preparing a submission and NB timelines threaten your calendar, now is the time to talk about it.
Sources
- NANDO — list of designated NBs, European Commission
- Notified bodies for medical devices — DG Santé
- ANSM — Designation of AFNOR Certification as an NB