Notified bodies (NBs) are third-party entities designated by the Member States and notified to the European Commission to assess the conformity of medical devices that require third-party assessment. Their number, their scope and their timelines have changed profoundly with the MDR. Choosing an NB without a method remains one of the most costly strategic mistakes in a certification project, and in 2026 the question of changing NB has joined that of the initial choice.
When is an NB required?
The involvement of an NB is mandatory for classes IIa, IIb and III. For class I, three sub-classes are also subject to it, each for a limited scope (Article 52(7)):
- Sterile devices (Is), for aspects relating to establishing, securing and maintaining the sterile condition.
- Devices with a measuring function (Im), for compliance with metrological requirements.
- Reusable surgical instruments (Ir), for aspects relating to reuse: cleaning, disinfection, sterilisation, maintenance, functional testing and the associated instructions for use.
This third sub-class is new under the MDR. Under the directive, a manufacturer of class I reusable surgical instruments self-certified entirely. Under the MDR, it now has an NB in its life. This is the case that still surprises the most manufacturers in 2026, particularly in instrument subcontracting.
For classes IIa to III, the assessment procedures are defined in Article 52 and Annexes IX to XI. The Annex IX route, assessment of the quality management system combined with assessment of the technical documentation, is the most commonly used.
What the NB actually assesses
The QMS. The NB audits the quality management system against the requirements of Annex IX. An existing ISO 13485 certification is taken into account, but the NB verifies the MDR-specific requirements that go beyond the standard: post-market surveillance, your vigilance obligations, the PRRC function required by Article 15, EUDAMED registrations.
The technical documentation. The examination is proportionate to the class. In class IIa, the NB assesses the documentation of at least one representative device per category of devices. In class IIb, sampling is done by generic device group. In class III, each device is examined. A broad portfolio in IIa or IIb will therefore not be read in full, but every file must be ready: the manufacturer does not choose the sample.
The clinical evaluation. The clinical evaluation report is systematically examined. It is the document that generates the most requests for additional information, and therefore the most weeks lost when it arrives immature.
How many NBs are designated, and where to find them
In 2026, around 45 to 50 bodies are designated under the MDR, compared with more than 80 under Directive 93/42/EEC. The more demanding designation process (Annex VII, joint assessment by Member State and Commission) explains this contraction: not all former NBs obtained or applied for their MDR designation.
The reference list is the European Commission’s NANDO database, now hosted on the Single Market Compliance Space. It is the first document to consult before any process: designations change during the year, both in extension and in restriction of scope.
How to choose an NB: the criteria that matter
The scope of designation. Each NB is designated for specific codes, defined by Implementing Regulation (EU) 2017/2185: MDA codes for active devices, MDN for non-active devices, MDS for specific characteristics (sterile, software, nanomaterials, etc.), MDT for technologies and manufacturing processes. Checking in NANDO that the NB covers the codes corresponding to your device is the first, non-negotiable step. A manufacturer of an active device that only looks at MDN codes is searching in the wrong place. For software, the MDS codes govern the classification of your software.
The observed timelines. The ranges observed in 2026: in the order of 9 to 18 months for an initial certification in class IIa, 12 to 30 months in IIb and III, with the Article 54 clinical consultation procedure adding its own delay for the devices concerned. These timelines vary according to the NB’s queue and, above all, according to the maturity of the submitted file. Contacting several NBs to obtain recent, written estimates remains the only reliable method: advertised timelines and lived timelines diverge.
The working language. If the regulatory team works mainly in a given language, an NB whose assessors are proficient in the regulatory team’s working language concretely smooths the question-and-answer cycles on the file.
The robustness of the contract. The contract commits the manufacturer for a full certification cycle. Termination conditions, transfer arrangements, handling of non-conformities, the fee schedule for surveillance audits: everything must be read before signing.
Changing NB during a certificate: Article 58
The first MDR certificates issued in 2021 and 2022 are coming up for renewal, and NB transfers are multiplying: restriction of the incumbent NB’s scope, timelines that have become incompatible with a launch, or fee revision. The MDR governs this voluntary change in Article 58.
The mechanism relies on a clearly defined agreement between the manufacturer, the incoming NB and, as far as possible, the outgoing NB. This agreement settles at a minimum the date on which the outgoing NB’s certificates cease to be valid, the date until which its identification number may appear in the information supplied by the manufacturer, the transfer of documents, and each party’s responsibility during the transition. The outgoing NB withdraws the certificates concerned on the agreed date.
Two realities to factor in before starting a transfer. First, the incoming NB does not take over a certificate on paper: it assesses. A transfer is prepared like a certification, with up-to-date documentation; it is the same work as preparing your MDR certification"" in the first place. Second, the schedule is built backwards from the expiry of the current certificate: a transfer started too late ends in a certificate gap, and therefore in a halt to placing on the market.
What this changes for a manufacturer in project mode
The NB does not assess an intention, it assesses a file. The requests for additional information that add six months to the timelines always concentrate on the same areas: insufficiently substantiated clinical evaluation, absent or decorative post-market surveillance data, gaps between the technical documentation and the reality of the QMS. These areas are audited before submission.
The rational sequence in 2026: check the designation codes in NANDO, consult two or three NBs with a precise product description to obtain written timelines, and review your file before submission"". A file that is mature at submission does more for the final timeline than any contractual negotiation.
Regulatory sources: Articles 52, 54 and 58 and Annexes VII and IX to XI of Regulation (EU) 2017/745, EUR-Lex. Implementing Regulation (EU) 2017/2185. NANDO database, European Commission.