Choosing Between Annex IX and Annex XI: Conformity Assessment Route Selection

Why route selection matters early

The conformity assessment route you choose — or more precisely, the route available to you given your device class — determines how you engage with a Notified Body, what documentation you submit first, and how long the process takes. Getting clear on this early shapes your project planning. Getting it wrong costs time that most manufacturers can't afford.

MDR sets out three main conformity assessment routes for devices that require a Notified Body: Annex IX (QMS audit plus technical documentation assessment), Annex X (type examination), and Annex XI (product verification). For most manufacturers of Class IIa, IIb, and III devices, the choice is between Annex IX and either Annex X or XI — and in many cases, the combination matters as much as the individual route.

Annex IX: the QMS-based route

Annex IX is the most commonly used route and, for Class III and implantable devices, it is mandatory as the primary route (combined with Annex IX Section 5 for clinical evaluation assessment, or with Annex X for type examination). For Class IIa and IIb devices, Annex IX is available as a standalone route.

The Annex IX route has two parts: a QMS audit and an assessment of technical documentation. The QMS audit evaluates whether your quality management system — structured around ISO 13485 in most cases — meets the requirements of Article 10 and Annex IX. Once the QMS is certified and your technical file is assessed, you receive a QMS certificate and (for Class IIb/III) a supplementary certificate for technical documentation.

One thing that trips teams up: the Annex IX route is not a one-time event. Notified Bodies conduct scheduled surveillance audits of your QMS (typically annually), and unannounced audits are possible. The QMS must remain compliant throughout the certification period — it's an ongoing relationship, not a one-time submission and approval.

Annex XI: product verification

Annex XI is a product-level route, not a system-level route. Under Annex XI Part A (type examination combined with production quality assurance) the Notified Body audits the production aspects of your QMS rather than the full QMS. Under Annex XI Part B (product conformity verification), the Notified Body verifies each batch or individual device.

In practice, Annex XI is most commonly used in combination with Annex X (type examination of the device design). It tends to be used by manufacturers who either don't have a full certified QMS or who are producing small volumes where batch verification is practical. For higher-volume manufacturers with an established QMS, Annex IX is usually more efficient over time — the upfront investment in QMS certification pays back through a streamlined path for future products.

An important constraint: Annex XI Part B (batch/individual verification) is not available for Class III devices. Class III manufacturers must go through Annex IX plus Annex X, or Annex IX alone with clinical evaluation assessment under Section 5.

Class-by-class breakdown

Class I devices (with exceptions for sterile, measuring function, reusable surgical instruments): manufacturer self-declaration, no Notified Body involvement required for the general class. If your Class I device has a sterile condition or measuring function, those specific aspects require Notified Body involvement under Annex IX or XI.

Class IIa: Annex IX (QMS only, full technical documentation assessment not required by default — sampled review applies), or Annex XI. Most Class IIa manufacturers use Annex IX.

Class IIb: Annex IX (with full technical documentation assessment for the device or device family), or Annex XI. Class IIb devices in Annex IX require assessment of at least one representative technical documentation per device category.

Class III and implantable devices: Annex IX (Chapter I + Chapter II Section 5 for clinical evaluation assessment, or combined with Annex X). These are the highest-scrutiny products — the Notified Body conducts detailed clinical evaluation assessment and is directly involved in the review of clinical data.

What the route selection means for your QMS

If you go Annex IX, you need a certified QMS in place before your technical documentation can be assessed. That means the QMS audit comes first — and for a manufacturer setting up a QMS from scratch, this can take twelve to eighteen months depending on the Notified Body's queue and your readiness. Factoring this into your project timeline is one of the most common planning mistakes we see.

If you go Annex XI, you avoid the full QMS audit but you take on product-level scrutiny instead. This may be appropriate for a first product launch where the QMS is still maturing, with a transition to Annex IX planned for subsequent products.

One practical point: Notified Bodies have different capacity and waiting times for different routes and device classes. Before finalising your route, check current timelines with two or three Notified Bodies — the difference in wait time can be significant and may influence which route is more practical for your launch window.