--- title: MDR Annex X: Type Examination — When and Why You Need It description: MDR Annex X type examination is one of the conformity assessment routes for higher-class devices. Here is when it applies and how it differs from Annex IX. authors: Tibor Zechmeister, Felix Lenhard category: Device Classification & Conformity primary_keyword: MDR Annex X type examination canonical_url: https://zechmeister-solutions.com/en/blog/mdr-annex-x-type-examination source: zechmeister-solutions.com license: All rights reserved. Content may be cited with attribution and a link to the canonical URL. --- # MDR Annex X: Type Examination — When and Why You Need It *By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.* > **Annex X of Regulation (EU) 2017/745 is the EU type examination route. A Notified Body examines a representative sample of the device. The "type". Against the MDR requirements and issues an EU type examination certificate if the type conforms. Annex X covers the design side of conformity assessment only. It must be paired with Annex XI, which covers the production side, to produce a complete conformity assessment under Article 52. It is an alternative to the full Annex IX route and is used for Class IIb non-implantable and some Class III devices where the manufacturer has a reason to separate design certification from production quality assurance.** **By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.** --- ## TL;DR - Annex X of Regulation (EU) 2017/745 is the EU type examination route: the Notified Body assesses a representative sample of the device against the MDR requirements and issues an EU type examination certificate. - Annex X covers the design side only. To complete a conformity assessment under Article 52, it must be combined with Annex XI, which covers the production side (production quality assurance or product verification). - The EU type examination certificate is valid for a maximum of five years and can be renewed on the basis of a re-assessment by the Notified Body. - Annex X is an alternative to the full Annex IX route for Class IIb non-implantable devices and for certain Class III devices where the design/production split is useful. - EN ISO 13485:2016+A11:2021 provides presumption of conformity for the QMS obligations that sit alongside Annex X/XI. The QMS does not disappear, it just lives in the Annex XI side of the pair. --- ## Why a founder should care about Annex X at all Most startups on an MDR path default to Annex IX without ever seriously reading Annex X. That default is often correct. But "often" is not "always," and the founders who have never looked at Annex X cannot tell when their situation is the exception. Annex X exists for a reason. It separates the certification of the device design from the ongoing oversight of production. For a startup with a stable type design and an unusual production setup, that separation can matter. For a startup whose design is still maturing, it rarely helps. The point of reading Annex X is not to pick it over Annex IX. The point is to know what Annex X is before a Notified Body mentions it in a quote, before a consultant suggests a "split route," and before a board member asks why you picked Annex IX. A founder who can explain the trade-off in one sentence is ahead of most of the room. This post walks through when Annex X applies, what type examination actually involves, what the type examination certificate is and is not, how Annex X pairs with Annex XI, how the route compares to Annex IX, and the misunderstandings that keep coming up in Notified Body quotes and consulting conversations. ## When Annex X applies Article 52 of Regulation (EU) 2017/745 lays out the conformity assessment procedures available by class. Annex X is not available to every device. It appears as part of a combined route alongside Annex XI, and the combination is available for specific classes. **Class IIb non-implantable devices.** Article 52 allows Class IIb non-implantable devices to use Annex X (EU type examination) combined with Annex XI (production quality assurance or product verification). This is the clearest use case. The manufacturer certifies the type under Annex X and then proves production conformity under Annex XI. **Class III devices.** For Class III devices, the combination of Annex X and Annex XI is available as an alternative to Annex IX, with the exception of certain categories where Annex IX is required. Class III implantable devices in particular route through Annex IX with full per-device technical documentation assessment. Where the Annex X/XI combination is available for Class III, it carries the same overall rigour as Annex IX. The split is procedural, not a lowering of the bar. **Class IIa devices.** The Annex X/XI combination is not the default route for Class IIa. Class IIa devices typically use Annex IX with representative technical documentation sampling, or the Annex XI production quality assurance route on its own. The design certification step that Annex X provides is usually not needed for Class IIa. **Class I devices.** Class I standard devices self-declare under Annex IV and do not touch Annex X at all. Class Is, Im, and Ir devices involve a Notified Body only for the specific aspect (sterility, measuring function, reusable surgical instrument) and do not route through Annex X. The practical effect is that Annex X is a route for higher-class devices where the manufacturer wants. Or the Notified Body recommends. The design/production split. Reading Article 52 before the Notified Body quote tells you which routes are legal for your class before anyone sells you one. ## What type examination actually involves Annex X describes type examination as the procedure whereby a Notified Body ascertains and certifies that a representative sample of the device covered. The "type". Meets the relevant provisions of the MDR. **What the manufacturer submits.** The manufacturer lodges an application with a single Notified Body. The application includes the name and address of the manufacturer, a written declaration that no application has been lodged with another Notified Body for the same type, the technical documentation drawn up in accordance with Annexes II and III of the MDR, and the samples of the type. The Notified Body may request further samples if needed. **What the Notified Body examines.** The Notified Body examines the technical documentation and verifies that the type has been manufactured in conformity with that documentation. It carries out or arranges for the appropriate assessments and tests necessary to check that the solutions adopted by the manufacturer meet the general safety and performance requirements of Annex I, in the cases where the standards referenced by the manufacturer have not been applied or have been applied only in part. The Notified Body also assesses the clinical evaluation carried out in accordance with Article 61 and Annex XIV. **The scope.** Type examination is about the design of the device. The Notified Body is checking whether the device, as designed and represented by the submitted samples, conforms to the MDR. It is not auditing day-to-day production. That side of the conformity assessment belongs to Annex XI, which is why Annex X cannot stand alone. **On-site elements.** While Annex X is focused on the type, the Notified Body can visit the manufacturing site as part of the examination to verify the production methods used to build the submitted samples and to confirm the documentation is consistent with how the samples were actually made. The Annex X visit is narrower than the full Section 2 QMS audit of Annex IX. ## The EU type examination certificate If the type meets the requirements, the Notified Body issues an EU type examination certificate to the manufacturer. The certificate contains the name and address of the manufacturer, the conclusions of the examination, the conditions of validity, and the data needed to identify the type approved. **Validity.** The EU type examination certificate is valid for a maximum of five years. Renewal requires a re-assessment by the Notified Body. The certificate lists the approved type and the scope of devices it covers. **What the certificate does not do.** The EU type examination certificate on its own does not authorise the manufacturer to place the device on the market. It certifies the design side. The manufacturer still needs the production-side certificate under Annex XI before the EU declaration of conformity can be drawn up and the CE marking affixed. This is the point that trips up founders who see the Annex X certificate arrive and think certification is done. **Changes to the approved type.** The manufacturer must inform the Notified Body of any change to the approved type that could affect conformity with the MDR. The Notified Body assesses the change and either extends the existing certificate or requires a new application. Changes include modifications to the design, intended purpose, conditions of use, or the characteristics on which the original assessment was based. ## Pairing Annex X with Annex XI for production Annex X and Annex XI are a pair. Annex X certifies the type. Annex XI certifies that serial production actually produces devices that match the certified type. **The two sub-routes inside Annex XI.** Annex XI offers two ways to cover the production side. The first is a production quality assurance system, where the Notified Body audits the manufacturer's production and final inspection QMS and issues a certificate confirming that the system is capable of producing devices conforming to the type. The second is product verification, where the Notified Body verifies conformity of manufactured devices either by examination and testing of every product or by examination and testing of products on a statistical basis. Most manufacturers choose the production quality assurance path because it is operationally closer to how a modern manufacturer actually works. **The QMS still exists.** A common misunderstanding is that Annex X/XI lets a manufacturer skip the QMS. It does not. The Annex XI production quality assurance path requires a QMS that meets the MDR requirements for production and final inspection. EN ISO 13485:2016+A11:2021 provides presumption of conformity for the QMS obligations in the same way it does for Annex IX Section 2. The QMS just lives in the Annex XI side of the pair rather than in a single Annex IX certificate. **Two certificates, two relationships.** The practical consequence is that the manufacturer holds two certificates under this route. The EU type examination certificate (Annex X) and the production quality assurance or product verification certificate (Annex XI). Usually both come from the same Notified Body, but they are separate certificates with separate surveillance obligations. ## Comparison with Annex IX Annex IX and the Annex X/XI combination cover the same ground. Design and production. But they arrive from different directions. **Annex IX bundles everything.** Annex IX runs the QMS audit, surveillance, and technical documentation assessment as one integrated procedure under one certificate. The Notified Body assesses the full QMS in Section 2, returns for annual surveillance in Section 3, and assesses the technical documentation on a class-dependent basis in Section 4. One audit track, one certificate, one five-year cadence. **Annex X/XI splits design from production.** Annex X assesses the type as a distinct procedure and issues a separate certificate. Annex XI then covers production through either production QA or product verification. Two certificates, two assessment tracks, still tied together because neither stands alone. **Where Annex IX usually wins for startups.** For most Class IIa and Class IIb non-implantable startups, Annex IX is operationally simpler and cheaper over the five-year life of the certificate. One Notified Body contract, one audit cadence, one surveillance relationship. The design and production sides are assessed together, which matches how a small team actually works. The people who designed the device are often the same people running production. **Where Annex X/XI can make sense.** A manufacturer with a stable type design and a production setup where the separation has a specific operational value may prefer the Annex X/XI split. Examples include a manufacturer using contract production where the design house and the production site have distinct QMS scopes, or a legacy device where a type examination certificate already exists and extending it is cheaper than re-building an Annex IX relationship from scratch. None of these cases are typical for a new startup. **What is identical.** The MDR requirements themselves do not change between routes. The GSPR in Annex I, the technical documentation in Annex II and III, the clinical evaluation under Article 61, the risk management, the post-market surveillance, the vigilance. All of it applies the same way. Annex IX and Annex X/XI are procedural wrappers around the same substantive requirements. ## Common misunderstandings about Annex X - **"Annex X is a cheaper Annex IX."** It is not. Over the five-year life of the certificate, the total Notified Body cost of the Annex X/XI pair is usually comparable to Annex IX, sometimes higher because two certificates mean two surveillance tracks. - **"Annex X means I do not need a QMS."** It does not. Annex XI production quality assurance requires a QMS for production and final inspection. EN ISO 13485:2016+A11:2021 still gives presumption of conformity for those obligations. The QMS does not disappear. - **"The type examination certificate lets me ship."** It does not. Without the Annex XI certificate, the declaration of conformity cannot be drawn up and the CE marking cannot be affixed. The type examination certificate is half of the pair. - **"Annex X is available for every class."** It is not. Article 52 restricts the routes by class. Class I does not use Annex X. Class III implantable devices route through Annex IX, not Annex X/XI. - **"Changes to the type do not need to be reported."** They do. Any change that could affect conformity with the MDR must be notified to the Notified Body, and the Notified Body decides whether the existing certificate still covers the change or whether a supplement or a new application is required. ## The Subtract to Ship angle on Annex X Subtract to Ship is suspicious of any route that adds surfaces a startup does not need. Annex X adds a surface. It splits the design and production sides of the conformity assessment into two tracks, two certificates, and two surveillance relationships. For a startup whose design and production live in the same small team, that split creates overhead without creating value. The subtract-to-ship answer is almost always Annex IX by default, and Annex X only when a specific operational reason points to it. That reason should be something the founder can state in one sentence. "we use contract production under a separate QMS," or "we hold a legacy type examination certificate we are extending." If the sentence cannot be written, the reason does not exist, and the route is Annex IX. The point is not that Annex X is wrong. The point is that routes exist to serve the work, not the other way round. Picking Annex X because it sounds sophisticated is the same mistake as building a QMS procedure because it sounds thorough. It adds weight without adding safety. ## Reality Check. Is Annex X the right route for your device? 1. Have you read Annex X and Annex XI of Regulation (EU) 2017/745 in full, directly from the consolidated text? 2. Does Article 52 actually make the Annex X/XI combination available for your specific class and device type? 3. Can you state in one sentence why the Annex X/XI split is better for your operation than a single Annex IX certificate? 4. Do your design and production activities live in separate QMS scopes that make the split procedurally easier? 5. Have you modelled the total five-year cost of the Annex X/XI pair against the five-year cost of Annex IX from the same Notified Body? 6. Do you understand that the EU type examination certificate on its own does not authorise placing the device on the market? 7. Can you trace every element of your Annex XI production QMS to a specific MDR requirement that the Notified Body will check? 8. Have you built a change-notification process that handles changes to the approved type under Annex X and changes to the production QMS under Annex XI as two distinct triggers? ## Frequently Asked Questions **What is MDR Annex X in plain terms?** Annex X of Regulation (EU) 2017/745 is the EU type examination route. A Notified Body examines a representative sample of the device. The "type". Against the MDR and issues an EU type examination certificate if the type conforms. It covers the design side of conformity assessment only and must be combined with Annex XI to cover production. **How long is an EU type examination certificate valid?** The EU type examination certificate issued under Annex X is valid for a maximum of five years. Renewal requires a re-assessment by the Notified Body. Any change to the approved type that could affect conformity with the MDR must be notified and assessed before the change is implemented. **Can a startup use Annex X on its own to place a device on the market?** No. Annex X covers the design side only. To complete the conformity assessment under Article 52, it must be combined with Annex XI, which covers production through either a production quality assurance system or product verification. Only once both certificates are in hand can the manufacturer draw up the EU declaration of conformity and affix the CE marking. **How does Annex X differ from Annex IX for a startup?** Annex IX is a single integrated procedure covering QMS audit, surveillance, and technical documentation assessment under one certificate. Annex X/XI splits design certification (Annex X) from production conformity (Annex XI) into two separate certificates. For most startups Annex IX is operationally simpler and cheaper over the five-year life of the certificate. **Does Annex X remove the need for EN ISO 13485:2016+A11:2021?** No. The QMS obligations still apply. The Annex XI production quality assurance path requires a QMS covering production and final inspection, and EN ISO 13485:2016+A11:2021 provides presumption of conformity for those QMS obligations in the same way it does under Annex IX Section 2. The QMS lives in the Annex XI side of the pair. **Which classes can use the Annex X/XI combination under Article 52?** Article 52 makes the Annex X/XI combination available for Class IIb non-implantable devices and, with exceptions, for certain Class III devices. Class IIa devices typically use Annex IX or Annex XI on its own. Class I standard devices self-declare under Annex IV and do not use Annex X at all. The exact availability must be read against Article 52 for the specific device class. ## Related reading - [The Subtract to Ship Framework for MDR Compliance](/blog/subtract-to-ship-framework-mdr) – the methodology that makes Annex X a deliberate choice rather than a default. - [MDR Device Classification Explained](/blog/mdr-device-classification-explained) – the classification hub that determines which routes Article 52 makes available for your device. - [MDR Annex VIII Classification Rules: Complete Guide](/blog/mdr-annex-viii-classification-rules-complete-guide) – the rules that place a device in the class that decides whether Annex X is even on the table. - [MDR Annex IX: Quality Management System-Based Conformity Assessment Explained](/blog/mdr-annex-ix-qms-conformity-assessment) – the integrated alternative that most startups choose over the Annex X/XI pair. - [MDR Annex XI: Production Quality Assurance Under MDR](/blog/mdr-annex-xi-production-quality-assurance) – the production-side annex that Annex X must be paired with to complete a conformity assessment. - [Choosing the Right Conformity Assessment Route for Your Startup's Device Class](/blog/choosing-conformity-assessment-route-startup) – the decision framework that most often lands startups on Annex IX rather than Annex X/XI. - [Conformity Assessment for Class I Devices: A Practical Checklist](/blog/conformity-assessment-class-i-checklist) – the Annex IV-based route for standard Class I devices that never touches Annex X. - [Class IIa Medical Devices Under MDR](/blog/class-iia-medical-devices-under-mdr) – the class where Annex X is rarely the right answer. - [Class IIb Medical Devices Under MDR](/blog/class-iib-medical-devices-under-mdr) – the class where Annex X/XI becomes a real alternative to Annex IX for non-implantable devices. - [Class III Medical Devices Under MDR](/blog/class-iii-medical-devices-under-mdr) – the class where Annex X availability is constrained by the implantable/non-implantable split. ## 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), Annex X (conformity assessment based on type examination), Annex IX (conformity assessment based on a quality management system and on assessment of technical documentation) for comparison, and Annex XI (conformity assessment based on product conformity verification) as the production-side pair to Annex X. Official Journal L 117, 5.5.2017. 2. EN ISO 13485:2016+A11:2021. Medical devices. Quality management systems. Requirements for regulatory purposes. Harmonised standard providing presumption of conformity for the QMS obligations that sit alongside Annex X/XI under the MDR. --- *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. Annex X is a route worth knowing well enough to decide against. And worth choosing only when the operation actually needs the split it creates.* --- *This post is part of the [Device Classification & Conformity](https://zechmeister-solutions.com/en/blog/category/classification) 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).*