--- title: IVDR Conformity Assessment Routes: Notified Body Involvement description: IVDR conformity assessment routes explained by class. Class A non-sterile self-declares, everything else needs a notified body at some level. authors: Tibor Zechmeister, Felix Lenhard category: IVDR & In Vitro Diagnostics primary_keyword: IVDR conformity assessment routes canonical_url: https://zechmeister-solutions.com/en/blog/ivdr-conformity-assessment-routes source: zechmeister-solutions.com license: All rights reserved. Content may be cited with attribution and a link to the canonical URL. --- # IVDR Conformity Assessment Routes: Notified Body Involvement *By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.* > **IVDR conformity assessment routes track the Class A through D risk scale. Only Class A non-sterile devices can be self-declared without notified body involvement. Everything else, from Class A sterile upwards, needs a notified body at some level, with Class D carrying the heaviest scrutiny. The routes mirror MDR in shape but not in detail.** **By Tibor Zechmeister and Felix Lenhard.** ## TL;DR - IVDR classifies in vitro diagnostic devices into Class A, B, C, and D based on risk to individuals and public health . - Class A non-sterile devices are the only category a manufacturer can bring to market under a self-declaration of conformity without notified body involvement. - Class A sterile, Class B, Class C, and Class D all require notified body involvement at escalating levels . - The IVDR Annex IX full QMS and technical documentation assessment route parallels MDR Annex IX [MDR VERIFY]. - Class D devices attract the highest scrutiny, including batch verification and reference laboratory involvement for devices where reference laboratories have been designated [MDR VERIFY]. - The IVD notified body pool is much smaller than the MDR pool. Route selection without an engaged notified body is premature. ## Why this matters Tibor has watched IVD founders make one specific planning mistake over and over. They look at the IVDR class of their device, glance at the conformity assessment annexes, pick what looks like the lightest route, and build a project plan around it. Nine months later, at the notified body kickoff, they discover the route is not quite what they thought, the evidence requirements are heavier, and the timeline is off by a quarter or more. The root cause is usually the same: they treated route selection as a document-reading exercise rather than a conversation with a notified body. Felix sees the same pattern from the business side. Founders pitch an IVD product to investors with a regulatory timeline that assumes the lightest plausible route. Investors accept the timeline because it sounds disciplined. Neither side has spoken to an IVD notified body. The first honest conversation with one reveals that the timeline was optimistic and the cash runway is now too short. This post is a plain-language map of the IVDR conformity assessment route logic. It is not a substitute for the IVDR text and it is not a substitute for a notified body conversation. It is a framework for asking the right questions before committing to a plan. ## What IVDR actually says about conformity assessment routes IVDR conformity assessment follows a risk-graded structure that any reader of MDR will recognise. The higher the class, the more involved the notified body . **Class A non-sterile.** The manufacturer draws up a technical documentation file to IVDR Annex II, runs a QMS, holds the declaration of conformity, and affixes the CE mark. No notified body is involved in the conformity assessment. This is structurally analogous to MDR Class I non-sterile, non-measuring, non-reusable-instrument self-certification . Important point Tibor raises repeatedly: self-declaration is not "no compliance work". The manufacturer still has to meet the GSPRs, run a compliant QMS, hold a complete technical file, run PMS, and be ready for a competent authority inspection. Self-declaration removes the notified body, it does not remove the regulation. **Class A sterile.** The moment sterility enters the picture, a notified body is required. The notified body's scope is limited to aspects related to establishing, securing, and maintaining sterility . The rest of the technical file is still the manufacturer's responsibility but is not scrutinised by the notified body in the same way. **Class B.** Notified body involvement steps up. A QMS audit aligned with the IVDR expectations is required, and the notified body assesses technical documentation on a sampling basis . The manufacturer cannot self-declare. **Class C.** Heavier scrutiny. Full QMS assessment and technical documentation assessment by the notified body. For generic device groups, the notified body reviews the technical file at a defined sampling rate . **Class D.** The heaviest route. Full QMS assessment, technical documentation assessment, and for devices in categories where an EU reference laboratory has been designated, the reference laboratory is involved in verifying performance claims . Batch verification obligations may apply depending on the specific device [MDR VERIFY]. The three annexes most often cited for IVDR conformity assessment routes map in broad terms to: - **Annex IX** [MDR VERIFY]: conformity assessment based on a quality management system and assessment of technical documentation. - **Annex X** [MDR VERIFY]: type examination. - **Annex XI** [MDR VERIFY]: conformity assessment based on production quality assurance. These annex numbers parallel the MDR Annex IX, X, and XI structure. The content differs in detail because the device type differs, but any team fluent in the MDR annex logic will find their way around the IVDR equivalents. ## A worked example A startup is developing two products under the same corporate umbrella. Product one is a specimen transport medium intended for use with respiratory virus PCR assays. Product two is the respiratory virus PCR assay itself, targeting a list of viruses with clinical significance. Product one is, depending on intended purpose and claims, potentially a Class A device . If it is non-sterile and the claims stay narrowly within specimen preservation during transport, the route is self-declaration. The startup writes its technical file, implements EN ISO 13485:2016+A11:2021, runs PMS, and ships with a declaration of conformity. No notified body, no certificate, no route fee. Product two is almost certainly Class C, possibly D depending on the specific viral targets and whether any are in the Class D list for high individual and public health risk . The route is full QMS assessment, full technical documentation assessment, and potentially reference laboratory involvement if any of the targets fall into a Class D category where a reference lab has been designated. The startup's first draft plan treated both products as "IVD products with a standard timeline". Tibor's review flagged the mistake. Product one's timeline can be genuinely lean because the notified body is not in the critical path. Product two's timeline is notified body-paced, reference-lab-paced for any Class D targets, and fundamentally different in risk profile. Collapsing the two into a single plan led to an internal assumption that the harder product would be ready at the same time as the easier one. It will not. The fix was a two-track plan: product one treated as a Class A self-declaration project with a tight timeline and an internal gate at declaration of conformity; product two treated as a full notified body project with the notified body conversation opened at month two of the programme, not month eight. The revised timeline added roughly nine months to product two and kept product one on its original track. ## The Subtract to Ship playbook for IVDR route selection Tibor's practical playbook for an IVD startup trying to pick a conformity assessment route without burning six months on a wrong plan. **Step 1. Lock the intended purpose first.** Under IVDR the intended purpose is what determines classification and therefore what determines the route . Fuzzy intended purpose equals fuzzy classification equals fuzzy route. Clarity first, route second. **Step 2. Classify conservatively, then challenge it.** Take the first classification pass seriously. Go through the IVDR classification rules in Annex VIII and pick the class. Then challenge the classification: could a notified body land one class higher based on a different read of intended purpose or target analyte. If yes, plan for that class until the notified body confirms. **Step 3. Open the notified body conversation early.** The IVD notified body pool is much smaller than the MDR pool. Tibor has seen startups wait until their technical file was substantially complete before contacting a notified body, only to discover capacity is not available in their planned quarter. For Class B, C, and D devices, an informal conversation at six months into development is not too early. **Step 4. Do not over-index on Annex IX [MDR VERIFY] as a default.** The Annex IX route that covers full QMS and technical documentation assessment is the most common route discussed in the literature, but it is not automatically the right route for every device. Alternative routes based on type examination (Annex X) or production QA (Annex XI) may fit the device and the manufacturing setup better [MDR VERIFY]. Discuss routes with the notified body. **Step 5. For Class A sterile devices, scope the notified body engagement narrowly.** The notified body's remit for Class A sterile is confined to sterility-related aspects [MDR VERIFY]. Do not let scope creep into the rest of the file. The narrow scope is the point of the route. **Step 6. For Class D devices, identify reference laboratory applicability early.** If the device target falls into a Class D category where a reference laboratory has been designated, reference laboratory involvement is part of the critical path . Pretending it is optional will cost the project time. **Step 7. Build the QMS once.** A startup with multiple IVD products across classes should build one EN ISO 13485:2016+A11:2021 QMS that serves all products. Splitting the QMS by product wastes effort. ## Reality Check 1. Has the intended purpose of each device been locked in writing, with precision sufficient to drive classification? 2. Has the classification been documented against the IVDR Annex VIII rules, with the reasoning written down? 3. For each device, is the route known at a level of detail that identifies the specific annex, the notified body scope, and any reference laboratory implications? 4. Has a notified body conversation been opened, given the smaller IVD notified body pool? 5. For Class A sterile devices, is the notified body engagement scoped narrowly to sterility-related aspects? 6. For Class D devices, has reference laboratory applicability been checked? 7. Is the timeline built from the notified body side, or is it built from internal development milestones and hoping the notified body side will fit? 8. If the company has multiple IVD products, is there one QMS serving all of them, or is effort being duplicated? ## Frequently Asked Questions **Can a Class A non-sterile IVD go to market without any notified body involvement?** Yes. The manufacturer runs a compliant QMS, holds a complete technical file, meets the GSPRs, runs PMS, draws up the declaration of conformity, and affixes the CE mark. No notified body certificate is required . **Is Class A sterile the same route as Class A non-sterile?** No. The sterility aspect pulls a notified body into the conformity assessment with a scope limited to establishing, securing, and maintaining sterility [MDR VERIFY]. **Does IVDR have fewer classification rules than MDR?** Yes. IVDR classification is built around what the device diagnoses and what substances it uses, with far fewer rules than the 22 rules of MDR Annex VIII. The risk-based logic is the same family. **Are the IVDR Annex IX, X, XI routes the same as the MDR ones?** They parallel each other in structure and purpose [MDR VERIFY]. The content is device-type-specific and the details differ. **Is finding an IVD notified body harder than finding an MDR notified body?** Yes. The pool is smaller. Tibor recommends opening the notified body conversation earlier than most founders expect. **What happens if a Class D device falls into a reference laboratory category?** Reference laboratory involvement becomes part of the conformity assessment and therefore part of the critical path timeline . ## Related reading - [MDR Conformity Assessment Routes](/blog/mdr-conformity-assessment-routes-which-path-right-device). the MDR-side framework that most of the IVDR logic mirrors. - [IVDR Technical Documentation Differences](/blog/ivdr-technical-documentation-differences). the technical file side of the same submission. - [What Is a Notified Body](/blog/what-is-notified-body). background for founders encountering notified bodies for the first time. - [MDR Annex IX QMS Conformity Assessment](/blog/mdr-annex-ix-qms-conformity-assessment). the MDR Annex IX route whose logic parallels the IVDR equivalent. ## Sources 1. Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), consolidated text. Annex VIII (classification rules), Annex IX, Annex X, Annex XI (conformity assessment procedures). All specific annex and rule references in this post flagged as [MDR VERIFY] for co-author confirmation. 2. Regulation (EU) 2017/745 on medical devices (MDR), consolidated text. Article 51, Annex VIII, Annex IX, Annex X, Annex XI for the parallel MDR route logic. 3. EN ISO 13485:2016+A11:2021. Medical devices, quality management systems. --- *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).*