Annex XI of Regulation (EU) 2017/745 is the production-side conformity assessment route under Article 52. It comes in two flavours: Part A, production quality assurance, where the Notified Body audits the manufacturer's production and final inspection QMS and certifies that the system is capable of producing devices that conform to the approved type; and Part B, product verification, where the Notified Body verifies conformity by examining and testing every device or by examining and testing devices on a statistical basis. Annex XI does not stand alone — it must be paired with Annex X type examination to produce a complete conformity assessment for Class IIb non-implantable devices and certain Class III devices. It is the alternative to the integrated Annex IX route.

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

TL;DR

  • Annex XI of Regulation (EU) 2017/745 is the production-side conformity assessment route anchored in Article 52, paired with Annex X type examination to cover the design side.
  • Part A is the production quality assurance path: the Notified Body audits the manufacturer's production and final inspection QMS and issues a certificate confirming the system produces devices that conform to the approved type.
  • Part B is the product verification path: the Notified Body verifies conformity of manufactured devices either by examining and testing every device, or by examining and testing devices on a statistical basis.
  • EN ISO 13485:2016+A11:2021 provides presumption of conformity for the QMS obligations under the Part A production quality assurance path, in the same way it does under Annex IX Section 2.
  • The Annex XI certificate is valid for a maximum of five years, with surveillance during the validity period, and must be held alongside a valid Annex X EU type examination certificate before the declaration of conformity can be drawn up.

When Annex XI applies

Article 52 of Regulation (EU) 2017/745 lays out which conformity assessment procedures are available by device class. Annex XI does not appear on its own — it appears as the production-side half of the Annex X plus Annex XI pair, and in a narrower role as a standalone option for certain lower-class devices.

Class IIb non-implantable devices. Article 52 makes the Annex X plus Annex XI combination available as an alternative to Annex IX. The manufacturer holds an EU type examination certificate under Annex X and a production-side certificate under Annex XI Part A or Part B. Together they carry the same rigour as a single Annex IX certificate.

Class III devices. For Class III devices where Article 52 allows the split route, the Annex X plus Annex XI combination is available. Class III implantable devices in particular route through Annex IX with per-device technical documentation assessment rather than through the split route.

Class IIa devices. Class IIa devices can in practice use Annex XI in a more limited role on top of a technical documentation sampling procedure, but most Class IIa startups default to Annex IX with representative sampling under Section 4. Reading Article 52 against the specific device class is the only way to confirm which routes are actually on the table.

Class I devices. Class I standard devices self-declare under Annex IV and do not touch Annex XI at all. Class Is, Im, and Ir devices bring a Notified Body in for the specific aspect only.

The practical effect is that most startups meet Annex XI only if they have already chosen the Annex X plus Annex XI split route. A founder who has defaulted to Annex IX will not touch Annex XI. A founder who has a specific operational reason to split design certification from production oversight will live inside Annex XI for five years.

Annex XI Part A — production quality assurance

Part A of Annex XI is the production quality assurance path. It is the option most manufacturers choose under the split route, because it is operationally closest to how a modern manufacturer already works.

What Part A requires. The manufacturer operates an approved quality management system for the production and final inspection of the devices concerned and is subject to surveillance by the Notified Body. The manufacturer lodges an application with a single Notified Body that includes the name and address, the information on the devices covered, a written declaration that no application has been lodged with another Notified Body for the same production QMS, the documentation on the QMS, a description of the procedures to keep the QMS effective, and a reference to the approved type covered by the Annex X certificate.

What the Notified Body audits. The Notified Body audits the production and final inspection QMS to determine whether it meets the MDR requirements. EN ISO 13485:2016+A11:2021 provides presumption of conformity for the QMS obligations, the same way it does under Annex IX Section 2. The auditor looks at the production processes, the final inspection and testing arrangements, the non-conformity handling, the traceability from incoming materials to finished devices, the corrective and preventive action system, the change control, and the integration of the QMS with post-market surveillance, vigilance, and technical documentation maintenance for the covered devices.

What the on-site audit looks like. The audit is on-site at the manufacturer's production premises and, where relevant, at critical suppliers and subcontractors. The auditor checks that the documented production QMS matches the lived production QMS — that the procedures on paper are the procedures on the shop floor. The same gap that trips up Annex IX Section 2 audits trips up Annex XI Part A audits: a beautiful manual with no daily evidence of use is the most common finding either way.

The outcome. If the Notified Body is satisfied, it issues a production quality assurance certificate. Combined with the Annex X type examination certificate, this allows the manufacturer to draw up the EU declaration of conformity and affix the CE marking. The certificate is valid for a maximum of five years, with annual surveillance during the validity period.

Annex XI Part B — product verification

Part B of Annex XI is the product verification path. It is the alternative to Part A, used by manufacturers who cannot or do not want to operate under a production quality assurance certificate.

What Part B requires. The manufacturer verifies conformity of the manufactured devices with the approved type and with the MDR requirements. The verification is carried out by the Notified Body, either by examination and testing of every product, or by examination and testing of products on a statistical basis.

Every-product verification. In the every-product path, the Notified Body examines every manufactured device, or arranges for appropriate tests on every device, to verify conformity with the approved type and the MDR requirements. This path is rare in practice because the cost and time scale linearly with production volume. It only makes sense for very low-volume, very high-risk devices where every-unit oversight is justified.

Statistical verification. In the statistical path, the Notified Body examines and tests devices on a statistical basis using sampling plans with operating characteristics that ensure a high level of safety and performance in accordance with the state of the art. The manufacturer presents batches of manufactured devices in the form of homogeneous lots, and the Notified Body draws samples and runs the examinations and tests. If a lot fails, the Notified Body takes the appropriate measures to prevent the non-conforming lot from being placed on the market.

What the Notified Body does in practice. The Notified Body carries out the examinations and tests necessary to verify conformity with the type and with the MDR requirements. This includes the examination and testing specified in any applicable harmonised standards and the verification that the devices are labelled and accompanied by the required information. The Notified Body draws up a written report of the examinations and tests.

Why Part B is rare for modern manufacturers. Part B is operationally heavy. Every-product verification does not scale. Statistical verification requires presenting homogeneous lots to the Notified Body on an ongoing basis, which creates a production rhythm dictated by the Notified Body rather than by the manufacturer. Part A production quality assurance is almost always the more efficient choice for a manufacturer running continuous or modern batch production. Part B survives for specific historical and regulatory reasons, not as a general-purpose production route.

The Annex X plus Annex XI pair

Annex X and Annex XI are designed to work together. Annex X certifies the design — the "type." Annex XI certifies that serial production produces devices matching the certified type. Neither stands alone.

How the two certificates relate. The Annex X EU type examination certificate identifies the approved type and the scope of devices it covers. The Annex XI certificate — whether Part A production quality assurance or Part B product verification — references the approved type and confirms that the production side meets the MDR requirements for devices conforming to that type. Together, the two certificates form a complete conformity assessment under Article 52. Only with both certificates in hand can the manufacturer draw up the EU declaration of conformity and affix the CE marking.

Why the split exists. The split exists because design and production are different activities, and there are manufacturing configurations where separating their certification makes sense. A manufacturer with a stable type design and an unusual production setup — contract production under a separate QMS scope, for example — may benefit from the clean separation. The split also preserves a legacy route that existed under the old directives and needed a path forward under the MDR.

Why most startups do not use the pair. For a startup whose design and production live in the same small team, the split creates overhead without creating value. Two certificates, two surveillance tracks, two sets of change notifications. Annex IX bundles everything under one contract with one Notified Body on one five-year cadence. The subtract-to-ship default for a startup is Annex IX, and Annex X plus Annex XI only when a specific operational reason points to the split.

Surveillance across the pair. Both certificates carry surveillance obligations. The Notified Body performs periodic surveillance assessments of the production QMS under Annex XI Part A, with unannounced on-site audits where appropriate. Changes to the approved type under Annex X must be notified to the Notified Body and assessed before implementation. Changes to the production QMS under Annex XI must also be notified. Founders who treat the two certificates as independent miss the point — they are one conformity assessment wearing two covers.

Comparison with Annex IX

Annex IX and the Annex X plus Annex XI pair cover the same substantive ground — design and production — but they arrive from different procedural directions.

Annex IX is one integrated certificate. Section 2 audits the full QMS including design and production. Section 3 covers annual surveillance. Section 4 assesses the technical documentation on a class-dependent basis. One audit track, one certificate, one relationship with the Notified Body.

Annex X plus Annex XI is two certificates. Annex X assesses the type and issues a type examination certificate. Annex XI assesses production and issues a separate production-side certificate. Two audit tracks, two surveillance cadences, two change-notification triggers.

Where Annex IX wins operationally. 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. The Notified Body sees the design and production sides together, which matches how a small team actually works. The people who designed the device are often the same people running production, and the QMS spans both naturally.

Where the Annex X plus Annex XI split can make sense. A manufacturer with a stable type design and a production setup where the design and production QMS scopes are already distinct may prefer the split. A manufacturer extending a legacy type examination certificate from the directives era may find the split cheaper than rebuilding an Annex IX relationship from scratch. Neither case is typical for a new startup.

What is identical across routes. The MDR requirements themselves. The general safety and performance requirements in Annex I, the technical documentation in Annex II and III, the clinical evaluation under Article 61, risk management, post-market surveillance, vigilance — all of it applies the same way regardless of route. Annex IX and the Annex X plus Annex XI pair are procedural wrappers around identical substantive obligations.

Common misunderstandings about Annex XI

  • "Annex XI means I skip the QMS." It does not. Part A production quality assurance is a QMS path. EN ISO 13485:2016+A11:2021 still provides presumption of conformity for the production and final inspection QMS obligations. The QMS does not disappear — it just covers a narrower scope than an Annex IX Section 2 QMS.
  • "Product verification under Part B is a cheap way to avoid an audit." It is not. Every-product verification does not scale, and statistical verification creates an ongoing Notified Body presence in production that is operationally heavier, not lighter, than a production QMS audit.
  • "I only need the Annex XI certificate to ship." No. Without a valid Annex X EU type examination certificate, the Annex XI certificate does not complete the conformity assessment. Both certificates must be in place before the declaration of conformity can be drawn up.
  • "Annex XI Part A is the same as Annex IX Section 2." It is not. Annex IX Section 2 audits the full QMS including design. Annex XI Part A audits the production and final inspection QMS — the design side is already covered by the Annex X type examination certificate. The scopes overlap but do not match.
  • "Changes to production do not need to be notified under Annex XI." They do. Changes to the approved QMS must be notified to the Notified Body, which assesses whether the modified system still meets the requirements. Founders who roll out production changes between surveillance audits without telling the Notified Body create findings they could have avoided.
  • "Annex XI is available for every class." It is not. Article 52 restricts the routes by class. Class I does not use Annex XI. The Annex X plus Annex XI pair is constrained by the same class-by-class rules that constrain Annex X.

The Subtract to Ship angle on Annex XI

Subtract to Ship is suspicious of any route that adds surfaces a startup does not need. Annex XI, in isolation from Annex X, does not exist as a full route for higher-class devices — it only exists as the production-side half of the split. The question is not "should I use Annex XI?" but "should I split my conformity assessment into design and production halves at all?" For most startups the answer is no, which means Annex XI is a route to read and understand and then set aside.

The startups that do use Annex XI are the ones that can write the one-sentence reason: "our design and production sit under separate QMS scopes," or "we are extending a legacy type examination certificate." The sentence has to be operational, not aspirational. Picking the split because it sounds sophisticated is the same mistake as building a QMS procedure because it sounds thorough. It adds weight without adding safety.

When the split is the right call, Part A production quality assurance is almost always the right sub-route. Part B product verification exists for specific cases and is rare in modern manufacturing. A startup that finds itself on the Part B path should check its assumptions — the operational cost of statistical verification is rarely worth it compared with building a production QMS that an auditor can certify under Part A.

Reality Check — Where do you stand on Annex XI readiness?

  1. Have you read Annex XI Part A and Part B of Regulation (EU) 2017/745 in full, directly from the consolidated text, alongside Annex X and Article 52?
  2. Do you have a specific, one-sentence operational reason for splitting your conformity assessment into Annex X plus Annex XI rather than running a single Annex IX certificate?
  3. If you are on the Annex XI path, do you hold — or have a clear plan to hold — the matching Annex X EU type examination certificate before shipping?
  4. Is your production and final inspection QMS built against EN ISO 13485:2016+A11:2021 and the specific MDR requirements a Part A audit will check?
  5. Have you modelled the total five-year cost of the Annex X plus Annex XI pair against the five-year cost of Annex IX from the same Notified Body?
  6. If you are considering Part B product verification, have you genuinely compared its operational cost with Part A production quality assurance, or did you assume Part B is cheaper because it sounds lighter?
  7. Do you have a change-notification process that handles changes to the production QMS under Annex XI as a distinct trigger from changes to the approved type under Annex X?
  8. Can you defend every element of your production QMS by tracing it to a specific MDR requirement the Notified Body will check under Annex XI Part A, rather than "because we thought we should"?

Frequently Asked Questions

What is MDR Annex XI in plain terms? Annex XI of Regulation (EU) 2017/745 is the production-side conformity assessment route under Article 52. It has two sub-routes: Part A production quality assurance, where the Notified Body audits the production and final inspection QMS, and Part B product verification, where the Notified Body verifies conformity of devices by examination and testing either of every device or on a statistical basis. It is paired with Annex X type examination to form a complete conformity assessment.

What is the difference between Annex XI Part A and Part B? Part A is a QMS audit path: the Notified Body certifies that the production and final inspection QMS is capable of producing devices that conform to the approved type. Part B is a device-level verification path: the Notified Body examines and tests either every device or devices on a statistical basis. Part A is the operational default for most manufacturers. Part B is rare because every-product verification does not scale and statistical verification creates an ongoing Notified Body presence in production.

Can a manufacturer use Annex XI on its own to place a device on the market? No. Annex XI covers the production side only. Without a valid Annex X EU type examination certificate, the conformity assessment is incomplete, and the manufacturer cannot draw up the EU declaration of conformity or affix the CE marking. Both certificates are required.

Does EN ISO 13485:2016+A11:2021 satisfy Annex XI Part A? EN ISO 13485:2016+A11:2021 provides presumption of conformity for the QMS obligations under Annex XI Part A, in the same way it does under Annex IX Section 2. A production and final inspection QMS certified to EN ISO 13485:2016+A11:2021 is the baseline. The Notified Body then checks the MDR-specific requirements on top, including the integration with post-market surveillance, vigilance, and technical documentation maintenance for the covered devices.

How long is an Annex XI certificate valid? An Annex XI certificate is valid for a maximum of five years. During the validity period, the Notified Body performs periodic surveillance of the production QMS under Part A, including unannounced on-site audits where appropriate, and assesses any notified changes to the approved system. Renewal requires a re-assessment at the end of the five-year term.

Is Annex XI cheaper than Annex IX for a startup? Usually no. Over the five-year life of the certificate, the total Notified Body cost of the Annex X plus Annex XI pair is comparable to Annex IX and can be higher because two certificates mean two surveillance tracks and two change-notification channels. For most startups Annex IX is operationally simpler and at least as cheap.

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 XI Part A (production quality assurance), Annex XI Part B (product verification), Annex X (conformity assessment based on type examination) as the design-side pair, and Annex IX (conformity assessment based on a quality management system and on assessment of technical documentation) for comparison. 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 under Annex XI Part A production quality assurance.

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 XI is the production-side half of a pair — worth reading in full so the split route is a choice, not an accident.