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MDR 2017/745 Reference

MDR Conformity Assessment Routes by Device Class

Which route applies to your device — Annex IX, X, or XI under Regulation (EU) 2017/745, mapped by risk class.

Find a Notified Body for MDR CE Marking Process Guide

Under MDR 2017/745, the conformity assessment route depends on your device's risk classification. Higher-risk devices require more intensive assessment and, in most cases, Notified Body involvement. This page maps each device class to its applicable conformity assessment annex and explains what each route involves.

Conformity Assessment Route by Device Class

Device Class Notified Body Primary Route Alternative Route
Class I ✓ No NB Self-declaration of conformity (Annex IV). Manufacturer prepares technical documentation (Annexes II & III) and issues the EU Declaration of Conformity. —
Class Is (sterile) ◐ Partial Self-declaration + NB assessment of the sterility aspects only (Annex IX Ch. I or Annex XI Part A). NB involvement limited to establishment, securing and maintaining sterile conditions.
Class Im (measuring) ◐ Partial Self-declaration + NB assessment of the metrological aspects only. NB involvement limited to conformity with metrological requirements.
Class Ir (reusable surgical) ◐ Partial Self-declaration + NB assessment of the reuse aspects only (cleaning, disinfection, sterilisation, maintenance). NB involvement limited to reprocessing-related aspects.
Class IIa ● NB required Annex IX (Ch. I + III): QMS assessment + technical documentation assessment on a representative basis (≥1 device per category). Annex XI Part A (production quality assurance) + technical documentation assessment.
Class IIb ● NB required Annex IX (Ch. I + III): QMS assessment + technical documentation assessment on a representative basis (≥1 device per generic device group). Annex X (EU type-examination) + Annex XI (Part A or B).
Class IIb implantable ● NB required Annex IX with technical documentation assessment for every device (not representative sampling). Stricter than non-implantable IIb. Annex X + Annex XI. Some well-established technologies (e.g. sutures) may use representative sampling.
Class III ● NB required Annex IX (Ch. I + II): full QMS assessment + design dossier examination for every device. Annex X (EU type-examination) + Annex XI Part A (production quality assurance).
Class III implantable ● NB + expert panel Annex IX + Clinical Evaluation Consultation Procedure (CECP) — expert panel review of the clinical evaluation assessment report (Article 54). Annex X + Annex XI + CECP. Custom-made Class III implantables follow Annex XIII.

The Three Conformity Assessment Annexes Explained

ANNEX IX
Conformity assessment based on a QMS and technical documentation

The most common route. The Notified Body audits the manufacturer's Quality Management System (Chapter I) and assesses the technical documentation. For Class IIa/IIb, this is on a representative sampling basis (Chapter III). For Class III and implantable IIb, the technical documentation is assessed for every device, including a design dossier examination (Chapter II). Includes ongoing surveillance audits.

Applies to: Class IIa, IIb, III (primary route)
ANNEX X
Conformity assessment based on type-examination

The Notified Body examines a representative sample of the device (the "type") and issues an EU type-examination certificate confirming the type meets MDR requirements. Annex X assesses the design and type, but does not on its own cover production — it must be combined with Annex XI (production conformity) to provide full conformity assessment. Used as an alternative to Annex IX for Class IIb and III.

Applies to: Class IIb, III (alternative route — combined with Annex XI)
ANNEX XI
Conformity assessment based on product conformity verification

Covers the production phase. Part A (production quality assurance) — the NB audits the manufacturing QMS to ensure devices are produced in conformity with the approved type or technical documentation. Part B (product verification) — the NB examines and tests every product or statistical samples. Annex XI is combined with Annex X (type-examination) as an alternative to the Annex IX route, or used for the production-quality element of Class IIa assessment.

Applies to: Class IIa (Part A), IIb, III (combined with Annex X)

How to Determine Your Device Class

Device classification is governed by the 22 classification rules in Annex VIII of MDR 2017/745, based on factors including: duration of contact (transient, short-term, long-term), invasiveness (non-invasive, invasive, surgically invasive, implantable), whether the device is active, and whether it affects vital physiological processes. If multiple rules apply, the device takes the highest resulting class.

Once your class is confirmed, the conformity assessment route follows from the table above. If you are unsure of your device's classification, a regulatory consultant or your prospective Notified Body can confirm it during the pre-application stage.

Frequently Asked Questions

What is the difference between MDR Annex IX, X, and XI?

Annex IX is conformity assessment based on a Quality Management System plus assessment of technical documentation — the most common route. Annex X is type-examination, where the NB examines a representative sample and issues an EU type-examination certificate. Annex XI covers production conformity (Part A: production quality assurance; Part B: product verification). Annex X is always combined with Annex XI to provide full coverage as an alternative to Annex IX.

Which conformity assessment route applies to a Class IIa device?

Class IIa devices follow Annex IX (Chapters I and III): a QMS assessment plus technical documentation assessment on a representative basis for at least one device per category. The alternative is Annex XI Part A (production quality assurance) combined with technical documentation assessment. A Notified Body is required for both routes.

Do Class I medical devices need a Notified Body?

Class I devices that are non-sterile, non-measuring, and not reusable surgical instruments are self-certified without Notified Body involvement (Annex IV self-declaration). Class I sterile (Is), measuring (Im), and reusable surgical (Ir) devices require Notified Body involvement, but only for the specific aspect — sterility, metrology, or reprocessing — not the entire device.

What conformity assessment route applies to Class III devices?

Class III devices follow Annex IX (Chapters I and II): full QMS assessment plus design dossier examination for every device. The alternative is Annex X (EU type-examination) combined with Annex XI Part A. Class III implantable devices additionally require the Clinical Evaluation Consultation Procedure (CECP) under Article 54, involving an expert panel review.

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