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Annex IX — QMS + Technical Documentation Assessment

Regulatory basis

MDR 2017/745, Annex IX and IVDR 2017/746, Annex IX. Annex IX is the most widely used conformity assessment route for Class IIa, IIb, III (MDR) and Class B, C, D (IVDR). It is the only permitted route for Class III (MDR) and Class D (IVDR).

Disclaimer

This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.

What Annex IX covers​

Annex IX is a QMS-based conformity assessment procedure. The notified body assesses two interlocking systems:

  1. The manufacturer's Quality Management System (QMS) — ensuring processes are in place to consistently design, manufacture, and control devices
  2. Technical documentation — evidence that the specific device meets all applicable requirements

Together, these give the notified body assurance that the manufacturer has the systems and evidence to place compliant devices on the market — and to maintain compliance over time.

Section 1 — QMS assessment​

Scope of QMS assessment​

The notified body assesses whether the manufacturer's QMS covers:

  • Device design and development
  • Production (manufacturing, assembly, testing)
  • Final product inspection and testing
  • Storage and distribution
  • Post-market surveillance
  • Complaints and vigilance handling
  • Corrective and preventive actions

The QMS must comply with EN ISO 13485:2016 as a minimum — but also incorporate all MDR/IVDR-specific requirements that go beyond ISO 13485.

Initial QMS audit​

The initial assessment involves:

  1. Document review: QMS documentation, procedures, and records
  2. On-site audit: inspection of manufacturing and other sites; interviews with key personnel; review of design and production records
  3. Audit report: findings, non-conformities, and corrective action requests
  4. Certificate decision: QMS certificate issued (or refused) based on audit outcomes

Surveillance audits​

After initial certification, the notified body conducts regular surveillance including:

  • Announced periodic audits: typically annually
  • Unannounced audits: mandatory for Class III devices (MDR Art. 93); at least once every 5 years for Class IIb

Unannounced audits can occur at any time without prior notice to the manufacturer. They assess production processes, records, and QMS implementation against the certified scope.

Section 2 — Technical documentation assessment​

For Class IIa devices: at least one representative device per generic group must have its technical documentation assessed.

For Class IIb devices: at least one representative device per category (more rigorous sampling than IIa).

For Class III devices: each device (or device variant within the scope of the application) must have technical documentation assessed.

What the notified body reviews​

The NB's technical documentation review covers:

  • Device description and specification (Annex II §1)
  • Labelling and IFU (Annex II §2)
  • Design and manufacturing information (Annex II §3)
  • GSPR cross-reference table (Annex II §4)
  • Benefit-risk analysis and risk management summary (Annex II §5)
  • Verification and validation data (Annex II §6)
  • Clinical evaluation report / performance evaluation report (Annex II §7)
  • Annex III post-market documentation (PMS plan, PSUR/PMS report, PMCF/PMPF)

Section 3 — Batch testing (Class D IVDR only)​

For IVDR Class D devices, Annex IX includes an additional requirement: the notified body must verify that each production batch meets the technical documentation specifications and EU reference laboratory findings before release. This provides the highest level of product-specific assurance for the highest-risk IVDs.

Section 5 — Clinical evaluation consultation (Class III MDR)​

For Class III devices, before issuing a certificate based on Annex IX, the notified body must carry out a clinical evaluation consultation under Art. 54(1):

  1. The NB assesses the clinical evaluation report and notifies an expert panel
  2. The expert panel reviews the clinical evaluation and issues a scientific opinion within 60 days
  3. The NB takes the opinion into account and must document any departure from it with justification
  4. Only then can the NB issue or renew the certificate

This process applies to Class III devices that do not rely on a device with an established clinical record (first-in-class or substantially changed devices).

The Annex IX certificate​

Upon successful assessment, the notified body issues an EU certificate that:

  • Identifies the manufacturer and scope (device(s) or device range covered)
  • Confirms QMS compliance with EN ISO 13485 and MDR/IVDR
  • Confirms technical documentation review for listed device(s)
  • Has a defined validity period (typically up to 5 years)
  • Is subject to the surveillance conditions set out in the certificate

Certificate details are entered into EUDAMED by the notified body.

Certificate renewal​

Certificates must be renewed before expiry. The renewal process is substantively similar to the initial assessment but:

  • Takes into account post-market surveillance data and PSUR/PMCF outcomes
  • Reviews any design or manufacturing changes since initial certification
  • May require a fresh unannounced audit or technical documentation review

Given current notified body capacity constraints, manufacturers should initiate renewal discussions at least 12 months before certificate expiry.

Official references​

ReferenceDescription
MDR Annex IXQMS-based conformity assessment
IVDR Annex IXIVDR equivalent
MDR Art. 52(4)–(6)Class-specific Annex IX requirements
MDR Art. 54Clinical evaluation consultation
MDR Art. 93Unannounced audits
EN ISO 13485:2016QMS for medical devices
MDCG 2019-6NB assessment of clinical evaluation