--- title: IVDR and the Notified Body Bottleneck description: The IVDR notified body pool is much smaller than MDR's. Here is how IVD startups should plan for that bottleneck realistically. authors: Tibor Zechmeister, Felix Lenhard category: IVDR & In Vitro Diagnostics primary_keyword: IVDR notified body bottleneck canonical_url: https://zechmeister-solutions.com/en/blog/ivdr-notified-body-bottleneck source: zechmeister-solutions.com license: All rights reserved. Content may be cited with attribution and a link to the canonical URL. --- # IVDR and the Notified Body Bottleneck *By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.* > **The IVDR notified body pool is much smaller than the MDR pool. Fewer designated bodies, narrower scope codes, longer queues. For an in vitro diagnostic startup in Class B, C, or D, that is a planning problem before it is a money problem. If a founder treats IVDR notified body engagement like MDR notified body engagement, the calendar will punish them. The honest plan: qualify the device early, map the real-world notified body scope options, start conversations 12 to 18 months before the file is ready, and design the technical documentation around what a resource-constrained IVD notified body can actually review.** **By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.** --- ## TL;DR - The IVDR (Regulation (EU) 2017/746) requires notified body involvement for Class B, Class C, and Class D devices. Only Class A non-sterile IVDs are fully self-declared. - The number of notified bodies designated under the IVDR is materially smaller than the number designated under the MDR. Tibor has observed this gap as a structural constraint, not a temporary one. - A smaller pool means fewer scope code combinations, fewer reviewers, and longer waiting times for an engagement slot. - An IVD startup that waits until its technical documentation is "almost done" before contacting a notified body will usually discover that the next available slot is months out. - The Subtract to Ship approach. Treat notified body capacity as a scarce resource. Plan for it like cash runway. - This post is about strategy and sequencing. It is not legal advice, and it is not a substitute for a scoping call with a specific notified body. --- ## Why this matters An in vitro diagnostic founder building a Class C assay walks into the IVDR assuming the pathway will look like MDR. Classify the device, build the quality management system, write the technical documentation, apply to a notified body, get certified. On paper the sequence is the same. In practice the bottleneck sits at step four. Under the MDR there are many designated notified bodies across the European Union. A startup with a reasonable Class IIa or IIb device can usually find multiple candidates willing to open a scoping conversation. Under the IVDR the designated pool is smaller. Considerably smaller. That is not a temporary artefact of the transition. In Tibor's direct experience guiding IVD companies through conformity assessment, the smaller pool is a durable feature of the IVDR landscape, and founders who fail to plan for it end up re-sequencing their entire go-to-market. The consequence is operational, not theoretical. Fewer notified bodies means fewer scope options. Fewer scope options means that a specific assay type, technology, or sample matrix may only be covered by two or three notified bodies in the entire union. Those two or three bodies each have finite auditor capacity. If every IVD startup in that niche is contacting them in the same quarter, the waiting list forms quickly and the first available slot drifts out by months. Sometimes more. ## What IVDR actually says about notified body involvement The IVDR is Regulation (EU) 2017/746. It classifies in vitro diagnostic medical devices into four classes based on risk to the individual and to public health. Class A for the lowest risk devices, Class D for the highest. The conformity assessment routes are laid out in IVDR Articles 48 and 49 and in the corresponding annexes. For Class A non-sterile devices the manufacturer self-declares against the general safety and performance requirements. No notified body is involved. That is the simple path, and it is the only self-declared path under the IVDR. Everything else requires a notified body. Class A sterile devices need notified body involvement for the sterility aspects. Class B devices need notified body assessment of the quality management system and sampled technical documentation. Class C devices need quality management system assessment plus technical documentation assessment on a per-generic-device-group basis. Class D devices sit at the top of the ladder with the most intensive conformity assessment, including involvement of EU reference laboratories where they are designated for the device category. The practical point. Once a founder leaves Class A non-sterile territory, they are in the notified body pool, and the pool is small. Classification under the IVDR is not a smaller version of MDR classification. IVDR has far fewer classification rules than MDR, and those rules turn on what the device is intended to diagnose or detect, what substances are used, and how the result informs clinical decision making. Tibor has repeatedly seen founders assume their device is Class A, work on that assumption for months, and then discover during a scoping call that the intended purpose phrasing puts them in Class B or Class C. The notified body bottleneck only matters if the classification lands the device inside the bottleneck, but many more devices land inside it than founders expect. ## A worked example Consider a hypothetical startup building a molecular assay for the early detection of a bacterial infection in primary care settings. The founder classifies it as Class C, correctly, because the result informs immediate treatment decisions for an infectious condition. The team builds the quality management system on EN ISO 13485:2016+A11:2021. The performance evaluation plan and the performance evaluation report are drafted. The technical documentation skeleton is in place. Total effort so far. About 14 months and most of a seed round. At month 15 the founder starts contacting notified bodies. The commercial assumption is that engagement will take four to six weeks, contract signature will happen by month 17, the audit will be in month 20, certification by month 24. The fundraising deck reflects this. The reality once the calls start. Of the notified bodies designated under IVDR, only a subset have scope codes covering molecular diagnostics for infectious disease. Of that subset, two are not accepting new clients. One is accepting new clients but the next available scoping call is three months out, and after the scoping call the earliest slot for an initial audit is another nine to twelve months. The fundraising deck now implies a timeline that cannot be delivered, not because the file is wrong, but because the calendar belongs to someone else. Felix has coached founders through exactly this kind of re-sequencing in adjacent regulated domains. The pattern is the same. The fix is not to work harder on the file. The fix is to contact notified bodies before the file is finished, get the real availability numbers, and rebuild the plan around the scarcest resource in the system. ## The Subtract to Ship playbook for IVDR notified body strategy Subtract to Ship is not about doing less regulatory work. It is about removing the steps and assumptions that do not contribute to getting a safe device on the market. For IVDR notified body engagement the playbook has five moves. **Move 1. Lock the classification early and in writing.** Before any notified body conversation, the founder needs a defensible classification rationale that cites the specific IVDR classification rule, the intended purpose sentence, and the reasoning that leads from one to the other. If the classification is ambiguous, name the ambiguity. Notified bodies do not enjoy guessing, and an ambiguous classification is the single fastest way to lose a scoping slot to a better prepared competitor. **Move 2. Map the notified body pool against the device scope.** Not every IVDR notified body covers every technology, every sample matrix, every indication. The scope codes matter. Before contacting anyone, the founder should build a short spreadsheet of every currently designated IVDR notified body, the scope codes each one holds, and whether each one is publicly accepting new clients. The published designation information is the starting point. The real answer only comes from direct outreach. **Move 3. Open conversations 12 to 18 months before the file is ready.** This is the move that most founders resist because it feels premature. It is not premature. Notified bodies are willing to take a preliminary scoping call on an incomplete file because it helps them plan their own capacity. The call is not a commitment. It is a seat reservation on a flight that has fewer seats than the queue. **Move 4. Design the technical documentation for review ergonomics.** An IVDR notified body reviewer is a person with a workload. A technical documentation file that is well-structured, cross-referenced, and explicit about performance evaluation evidence will be reviewed faster than a file of the same content that is poorly organised. The quality of the evidence matters most. The ergonomics of the file matter more than founders think. **Move 5. Build the fundraising and commercial plan around a realistic calendar.** If the earliest credible certification date is month 30, the plan should say month 30, plus a buffer. A plan that says month 20 because it sounds better to investors will collide with reality at exactly the worst moment. Felix has watched this specific collision damage more startups than regulatory cost overruns ever have. The founders who execute this playbook do not get shorter notified body queues. They get accurate ones. That is the difference between shipping and not shipping. ## Reality Check 1. Does the device classification under IVDR rest on a written rationale with specific rule citation, or on an assumption the founder made early and never revisited? 2. Has someone on the team built a current map of IVDR notified bodies and their scope codes relevant to the device? 3. How many of those notified bodies are publicly accepting new clients this quarter? 4. Has the team had any direct contact with a notified body, or is the plan built on published timelines alone? 5. If the next available scoping call is three months out and the first audit slot is twelve months after that, does the fundraising plan still work? 6. Is the technical documentation file being written with a specific reviewer ergonomics in mind, or as an internal document that "will be reformatted later"? 7. If the preferred notified body loses its designation or stops accepting new clients, is there a named second option? 8. Who on the team owns the relationship with the notified body, and do they have the calendar authority to move fast when a slot opens? If any of these questions do not have a confident answer, the notified body bottleneck is already shaping the startup's reality, whether or not the founder has noticed. ## Frequently Asked Questions **How many notified bodies are currently designated under the IVDR?** The number varies as designations are added or removed, and the public NANDO database is the authoritative live source. The operational point is that the number is materially smaller than the MDR pool and should be treated as a constraint. A founder should check NANDO directly rather than relying on secondhand counts. **Can an IVD startup self-declare under the IVDR?** Only if the device is Class A and non-sterile. Everything else, including Class A sterile, requires notified body involvement. Self-declaration is not a general option under the IVDR the way it is for Class I non-sterile non-measuring devices under the MDR. **What happens if a notified body loses its IVDR designation mid-project?** The certificate becomes invalid within a period specified by the regulation, and the manufacturer has to transition to another designated body. This is a real risk given the size of the pool, and it is one reason the Subtract to Ship playbook includes having a named second option before signing the first contract. **How long does a typical IVDR Class C conformity assessment take once contracted?** Tibor has seen ranges from nine months to more than eighteen months, depending on the quality of the file, the responsiveness of the manufacturer, and the notified body's own workload. The contracted start date is not the same as the available start date, and the available start date is often months after contract signature. **Does the notified body bottleneck affect Class B devices as much as Class C and D?** Yes, in the sense that Class B still requires notified body involvement and competes for the same reviewer capacity. The assessment scope is lighter, but the queue is the same queue. **Is there any way to accelerate a notified body engagement?** The honest answer is no, not through effort alone. What does help. Starting conversations early, presenting a well-organised file, having a classification rationale that does not need to be renegotiated, and being the customer that reviewers find easy to work with. None of these remove the queue. They place the founder higher in it. ## Related reading - [Notified Body Bottleneck Under the MDR](/blog/notified-body-bottleneck). The MDR version of the same structural problem, for comparison. - [What Is a Notified Body](/blog/what-is-notified-body). Foundational explainer on the role notified bodies play in European conformity assessment. - [How to Choose the Right Notified Body](/blog/choose-right-notified-body). Selection criteria that apply with even more force when the pool is smaller. - [IVDR Compliance Checklist for In Vitro Diagnostic Startups in 2026](/blog/ivdr-compliance-checklist-2026). The phase-by-phase closing checklist for the IVDR mini-cluster. - [The Subtract to Ship Framework for MDR](/blog/subtract-to-ship-framework-mdr). The broader methodology this post draws on. ## Sources 1. Regulation (EU) 2017/746 on in vitro diagnostic medical devices, consolidated text. Articles 48 and 49. Annexes VII and IX. 2. European Commission, NANDO database of notified bodies designated under Regulation (EU) 2017/746. 3. EN ISO 13485:2016+A11:2021, quality management systems for medical devices. 4. Tibor Zechmeister, direct experience guiding IVD companies through IVDR conformity assessment, 2022 to 2026. --- *This post is part of the [IVDR & In Vitro Diagnostics](https://zechmeister-solutions.com/en/blog/category/ivdr) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*