Under Article 52 of Regulation (EU) 2017/745, the conformity assessment route a manufacturer can use is determined by the device class. Class I standard devices self-declare under Annex IV. Class IIa, IIb, and III devices must use a Notified Body route based on Annex IX (full quality management system plus technical documentation assessment), or the combination of Annex X (EU type examination) with Annex XI (production quality assurance or product verification). For most startups the Annex IX route is cheaper over the life of the certificate, faster to the first certificate once the QMS is in place, and the default choice unless a specific reason points elsewhere.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • MDR Article 52 sets out the conformity assessment procedures available by class. The manufacturer does not have a free choice. The class constrains the set of legal routes.
  • Annex IX is the full route: the Notified Body audits the quality management system and assesses the technical documentation. Most startups on a Class IIa or IIb path take this route.
  • Annex X (EU type examination) combined with Annex XI (production quality assurance or product verification) is the alternative split route. It is more common for devices where type-testing on a physical specimen is the cleanest proof of conformity.
  • Annex IV covers the EU declaration of conformity that every manufacturer issues, and is the self-declaration route for standard Class I devices where no Notified Body certificate is needed for the device itself.
  • For Class III and implantable Class IIb devices, the routes are narrower and the assessment is deeper, with additional scrutiny under Article 54 for certain devices.
  • The cost, calendar, and operational implications of the routes differ. For a cash-constrained startup, the route decision is never a rubber stamp.

Why the route decision matters more than founders expect

Classification tells you which conformity assessment procedures are legally available. The route decision tells you which one you will actually use. These are two separate choices, and the second one gets treated as a formality by founders who have already spent their energy on the first. That is a mistake. The route determines what the Notified Body audits, when, how often, and how much of the file they look at in each cycle. It shapes the first-certificate timeline and the yearly surveillance cost for the five years the certificate is valid. It decides whether you build your proof around a physical type specimen or around a documented QMS and a representative technical file.

The founders we coach often discover the route question the day they sit down with a Notified Body to scope the quote. By then the QMS scope is already set, the test plan is already written, and the choice has effectively been made by accident. A deliberate route decision, made at the point the class is confirmed, avoids that. It also avoids the two failure modes we see most often: paying for an Annex X type examination on a software device where the physical specimen is largely ceremonial, and skipping the Annex XI production assurance step on a hardware device where it would have been cheaper than the full QMS route.

This post walks through the main routes under Article 52. Annex IX, Annex X with Annex XI, and Annex IV. And then covers what the trade-offs actually look like for a resource-constrained startup.

Mapping the classes to the allowed routes

Article 52 of Regulation (EU) 2017/745 lays out the conformity assessment procedures available for each class. The full detail is in the article itself and the referenced annexes, and the authoritative interpretation layer is MDCG 2021-24. The short version looks like this.

Class I standard devices. The manufacturer prepares the technical documentation in line with Annexes II and III, applies the relevant general safety and performance requirements, and draws up the EU declaration of conformity under Annex IV. No Notified Body certificate is issued for the device itself. The manufacturer affixes the CE marking and is responsible for ongoing compliance.

Class I sterile, Class I with measuring function, Class I reusable surgical instruments (Is, Im, Ir). A Notified Body is involved for the specific aspect. Sterility, metrological aspects, or reprocessing of the instrument. Under the applicable parts of Annex IX or the Annex X plus Annex XI combination. The rest of the device conformity assessment is still on the manufacturer.

Class IIa. Conformity assessment is either by Annex IX (full QMS audit plus technical documentation assessment on a representative basis across the devices covered) or by the combination of Annex XI (production quality assurance) with the technical documentation assessment that Article 52 requires for Class IIa. Annex IX is the typical default.

Class IIb non-implantable. Conformity assessment is either by Annex IX (with technical documentation assessed on a representative basis per category of devices) or by Annex X (EU type examination) combined with Annex XI (production quality assurance or product verification). Class IIb implantable devices face a deeper version of Annex IX with technical documentation assessment for each device.

Class III. The most rigorous routes apply. Annex IX applies with full technical documentation assessment for each device, or Annex X type examination applies combined with Annex XI. Class III implantables and certain Class III devices also fall into the clinical evaluation consultation procedure under Article 54.

The exact wording of Article 52 is the source of truth. The table above is orientation. The actual decision is always made by reading Article 52 against the confirmed class.

The Annex IX route. Full QMS plus technical documentation assessment

Annex IX is the route most startups end up on once they cross into Class IIa territory. Structurally, Annex IX has two halves. The first half is the quality management system assessment: the Notified Body audits the manufacturer's QMS against the MDR requirements, using EN ISO 13485:2016+A11:2021 as the harmonised standard that provides presumption of conformity for the QMS obligations. The second half is the technical documentation assessment: the Notified Body reviews the technical documentation prepared in accordance with Annexes II and III.

For Class IIa devices, the technical documentation is assessed on a representative basis across the devices covered by the certificate. For Class IIb non-implantable devices, the sampling is deeper. For Class IIb implantable and Class III devices, the technical documentation is assessed for each device or device group, not on a sample basis. The practical effect is that the same Annex IX route scales with class: light-touch sampling at Class IIa, comprehensive per-device review at Class III.

The certificate issued under Annex IX is valid for up to five years, with annual surveillance audits. At each surveillance, the Notified Body re-audits parts of the QMS and samples the technical documentation again. The cycle continues until renewal.

Why Annex IX is usually the right default for startups. It covers everything in one procedure. The QMS audit is something the startup needs anyway. You cannot run the company without a working QMS, so the audit confirms work you were going to do. The technical documentation review happens alongside, under the same contract, in the same review cycle, with the same Notified Body team. The alternative split route (Annex X plus Annex XI) adds a second formal step. Type examination on a specimen. Which for most software-driven and software-only devices adds cost without adding clarity.

The Annex X plus Annex XI split route. Type examination with production assurance

Annex X is the EU type examination procedure. The manufacturer submits a representative specimen of the intended production. The "type". Along with the technical documentation, and the Notified Body examines and tests the type to verify that it meets the applicable requirements. The output is an EU type-examination certificate.

Annex X on its own is not a complete conformity assessment. It proves that one specimen meets the requirements, not that every unit produced will. It has to be combined with a production-phase procedure. The combinations allowed under Article 52 are Annex X with Annex XI (production quality assurance), or Annex X with the product verification part of Annex XI. Annex XI production quality assurance is a QMS audit focused on production and final inspection, narrower in scope than Annex IX, which covers the full QMS.

When the split route fits. Annex X plus Annex XI often fits devices where the cleanest evidence of conformity is a physical test on a specimen. Hardware devices with well-defined test protocols, devices where the design is stable and production consistency is the main concern, or devices where the manufacturer prefers to decouple the design certification from the production certification. It can also be the right choice when a manufacturer wants to produce under contract with a separate entity running production, because the production QA step can sit with the production site.

When it does not fit. For pure software devices, the type specimen concept is largely formal, and the full Annex IX route usually makes more sense. For startups that have one product and one production line, the split route often adds process without reducing cost. The Annex XI production QA step still requires a QMS audit, and the Annex X type examination is an additional cycle of work on top of the technical documentation review that would happen under Annex IX anyway.

The Annex IV self-declaration route for Class I

Annex IV of the MDR is the EU declaration of conformity itself. The document every manufacturer must draw up, regardless of class, once conformity is confirmed. For standard Class I devices, Annex IV is the end of the route: the manufacturer compiles the technical documentation, verifies that the device meets the general safety and performance requirements of Annex I, runs the clinical evaluation required under Article 61 at the level appropriate for Class I, issues the EU declaration of conformity under Annex IV, and affixes the CE marking. No Notified Body certificate is required for the device itself.

What the founder is actually responsible for under the Annex IV route is the complete technical documentation, a working QMS proportionate to the risk class (the QMS obligation under Article 10(9) does not disappear for Class I), the clinical evaluation, registration in Eudamed, PMS system under Article 83, vigilance reporting under Articles 87–92, and the EU declaration of conformity itself. The absence of a Notified Body certificate does not mean the absence of obligations. It means the manufacturer takes on the verification responsibility directly.

The Annex IV route is the cheapest in direct Notified Body fees. Zero. But it concentrates risk on the manufacturer. If a Competent Authority inspects the file years later, there is no Notified Body certificate to point at. The manufacturer's own file has to stand on its own.

What is cheaper, what is faster, what is riskier

Cost, time, and risk do not move in the same direction across the routes. A founder picking a route by "cheapest" alone will often pick the wrong one.

Cheapest in direct Notified Body fees. Annex IV for standard Class I. No Notified Body fees for the device itself.

Cheapest in total cost of compliance for Class IIa–IIb. Annex IX is usually cheapest over the five-year certificate, because it consolidates the QMS audit and technical documentation review into one contract with one Notified Body team. The Annex X plus Annex XI split adds a type examination cycle that most startups do not need.

Fastest to first certificate. Depends on readiness. Annex IX is fastest when the QMS is ready before the technical documentation. Annex X plus Annex XI can be faster when the technical documentation and a stable physical specimen are ready before the QMS, because the type examination can proceed while the production QMS is being finalised. In practice, for software-driven startups, the QMS is usually the critical-path item regardless, so Annex IX is the faster path in most cases.

Riskiest for the manufacturer. Annex IV, because it concentrates responsibility on the manufacturer with no Notified Body certificate as a safety net. Startups that choose Annex IV because the device is Class I must run the QMS and the technical file at a level that would survive a Competent Authority inspection, not just at a level that looks reasonable internally.

Most predictable. Annex IX, because the cycle is well-understood, the Notified Body teams have run it thousands of times, and the surveillance cadence is documented. Founders can plan around it.

Strategic considerations for a startup

The route decision is strategic, not procedural. A few considerations that change the calculus.

Product architecture. A software-only or software-led device usually lands on Annex IX. A hardware device with a stable physical design and a long expected production run often has a stronger case for Annex X plus Annex XI.

Single product versus product family. If the startup plans to ship one device and iterate, Annex IX and its representative sampling model works well. If the startup plans a family of related devices, Annex IX still works and the certificate can cover the family. But the sampling rules matter, and the scoping of the certificate deserves care at the point of the quote.

Production model. If the startup will contract production to a separate entity, the split Annex X plus Annex XI route allows the production QA step to live with the contract manufacturer's QMS. If production is in-house, Annex IX covers it naturally.

QMS maturity. Annex IX front-loads the QMS audit. If the QMS is not ready, Annex IX will stall. If the QMS is close to ready, Annex IX is the fastest path because it consolidates everything.

Runway and burn. The split route has two billable cycles (type examination plus production QA audit). Annex IX has one consolidated cycle. For a startup on tight runway, fewer cycles usually beats more cycles.

Notified Body capacity. The capacity of the Notified Body you plan to work with affects route timing. Some bodies have more experience with software devices on Annex IX; others have deeper hardware testing capacity for Annex X type examination. This is a real factor in the choice and worth discussing openly with the Notified Body before signing the quote.

The Subtract to Ship angle

The Subtract to Ship framework treats route selection as a natural extension of the Classification Pass. Once the class is fixed and the intended purpose is stable, the question becomes: what is the lightest legal route through Article 52 that actually fits the device? The word that matters is "fits." The cheapest quote is not always the cheapest route. The fastest procedure on paper is not always the fastest certificate in practice. The route that fits is the one whose structure matches the device's architecture, the startup's team, the production model, and the QMS maturity.

Subtracting here means cutting the appeal of routes that look clever but add process the device does not need. A type examination on a software device because "everyone does a type examination" is added process, not subtracted. A split route because "it feels more thorough" is added process, not subtracted. The framework asks the same question as always: does this trace to a specific MDR obligation that applies to this device, or is it there because it looked like diligence? If the latter, cut it.

Reality Check. Where do you stand on route selection?

  1. Do you know, from Article 52 directly, which conformity assessment routes are legally available for your device class?
  2. For each available route, have you identified the specific annex (IV, IX, X, XI) it is built on and read that annex in full?
  3. If you are leaning toward Annex X plus Annex XI, can you articulate why the split route fits your device better than Annex IX alone?
  4. Have you mapped the cost and calendar of each available route across the five-year certificate cycle, not just the first certificate?
  5. Is your QMS closer to ready than your technical documentation, or the other way around, and does your chosen route match that reality?
  6. Have you discussed the route openly with the Notified Body you intend to engage, including their capacity and experience with your device type?
  7. For Class I, have you confirmed whether you are standard Class I (Annex IV only) or Is/Im/Ir (Notified Body involved for the specific aspect)?
  8. Can you defend your route choice by tracing it to a specific Article 52 provision and the matching annex, not to a general preference?

Frequently Asked Questions

Can a startup choose any conformity assessment route it wants? No. Article 52 of Regulation (EU) 2017/745 restricts the available routes by device class. Within the set of legal routes for a given class, the manufacturer can choose, but outside that set there is no choice. A Class IIa device cannot be certified via Annex IV, and a standard Class I device does not need a Notified Body certificate at all.

Is Annex IX always cheaper than Annex X plus Annex XI? For most startups with one product and in-house production, yes, because Annex IX consolidates the QMS audit and technical documentation review into one cycle. For hardware devices with stable designs and contract production, the Annex X plus Annex XI route can be cost-competitive because the type examination and the production QA step fit that structure cleanly. The answer depends on the device and the operational setup.

What is the difference between Annex IV and the other annexes? Annex IV is the EU declaration of conformity that every manufacturer must draw up, regardless of class. For standard Class I devices, Annex IV is the entire conformity assessment output. No Notified Body certificate is issued. For Class IIa and above, the declaration of conformity under Annex IV is drawn up after the Notified Body has issued its certificate under Annex IX or the Annex X plus Annex XI combination.

Can the conformity assessment route change after the certificate is issued? Changing routes mid-certificate is not straightforward. The route is part of the scope of the Notified Body contract and the certificate. A change typically means a new application, a new assessment, and a new certificate. For a startup, the practical advice is to pick the route deliberately at the start and plan the five-year certificate around it, rather than expecting to switch later.

Does the route choice affect the clinical evidence requirements? The clinical evidence requirements flow from Article 61 and Annex XIV based on the device class and the device itself, not directly from the conformity assessment route. The route affects how and when the Notified Body reviews the clinical evidence, not whether the evidence is required. Class III and implantable Class IIb devices face the deepest clinical evidence review regardless of route.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 52 (conformity assessment procedures), Article 54 (clinical evaluation consultation procedure for certain Class III and Class IIb devices), Annex IV (EU declaration of conformity), Annex IX (conformity assessment based on a quality management system and on assessment of technical documentation), Annex X (conformity assessment based on type examination), Annex XI (conformity assessment based on product conformity verification). Official Journal L 117, 5.5.2017.
  2. MDCG 2021-24. Guidance on classification of medical devices, October 2021.
  3. EN ISO 13485:2016 + A11:2021. Medical devices. Quality management systems. Requirements for regulatory purposes.

This post is part of the Device Classification & Conformity Assessment series in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. The route decision is one of the most consequential commercial choices a startup makes inside the MDR framework, and deserves the same care as the classification decision that precedes it.