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Annex X — EU type examination

Regulatory basis

MDR 2017/745, Annex X and IVDR 2017/746, Annex X. Annex X defines the EU type examination procedure. It is used in combination with Annex XI (Part A or B) and is available for Class IIa, IIb (MDR) and Class B, C (IVDR). Not available for Class III (MDR) or Class D (IVDR), which must use Annex IX.

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 is EU type examination?​

EU type examination is an assessment by a notified body of the technical design of a device — represented by a physical specimen (the "type") — to verify that it complies with all applicable MDR or IVDR requirements.

Unlike Annex IX which assesses the manufacturer's QMS and how it applies across a range of devices, Annex X focuses on a specific device design as embodied in the submitted specimen(s).

The type examination process​

Step 1 — Application and documentation​

The manufacturer submits to the notified body:

  • Full technical documentation (Annex II)
  • Specimens representative of the planned production
  • For each specimen: sufficient samples to enable complete assessment

"Sufficient samples" means the NB can perform all necessary tests and examinations. For complex devices or devices with multiple variants, multiple specimens may be needed.

Step 2 — Examination and testing​

The notified body:

  1. Reviews the technical documentation for completeness and adequacy
  2. Examines the specimen(s) — checking that they match the technical documentation
  3. Conducts or arranges tests where harmonised standards do not cover the GSPR adequately or where test results are inconclusive from documentation alone
  4. Verifies that the manufacturer applied the appropriate harmonised standards (or equivalent) correctly

The NB may carry out tests itself, or arrange for tests to be performed at an external laboratory under its supervision.

Step 3 — EU type examination certificate​

If the type meets all applicable requirements, the notified body issues an EU type examination certificate specifying:

  • The device type examined
  • The results and conclusions of the examination
  • The conditions of validity
  • Data necessary to identify the approved type

The certificate is entered into EUDAMED.

Certificate validity and renewal​

EU type examination certificates are valid for up to 5 years and can be renewed. Renewal requires:

  • Re-examination if the device type has changed significantly
  • Updated technical documentation reflecting any changes
  • Review of post-market surveillance data

Changes to the approved type​

If the manufacturer makes changes to the approved type, the notified body must be informed. The NB assesses whether the changes are significant:

  • Non-significant changes: the NB may issue a supplement to the existing certificate
  • Significant changes (affecting safety, performance, intended use): may require a new type examination

MDCG 2020-3 defines criteria for significant changes.

When to use Annex X rather than Annex IX​

Annex X + XI is typically chosen when:

  • The product range is limited and well-defined (a small number of clearly specified device types)
  • The device has a stable design with infrequent changes
  • The manufacturer wants focused notified body review of a specific device's technical performance rather than a QMS-level assessment
  • Initial speed is a priority (Annex X can sometimes be faster for simpler devices)

For manufacturers with large, evolving device portfolios, Annex IX is usually more efficient. Annex X certificates must be renewed or supplemented every time the device type changes significantly, which can be burdensome.

Annex X is not available for all classes​

ClassAnnex X available?
MDR Class IIaYes
MDR Class IIbYes
MDR Class IIINo — Annex IX only
IVDR Class BYes
IVDR Class CYes
IVDR Class DNo — Annex IX only

Annex XI — product conformity verification​

Annex XI must always be used in conjunction with Annex X. It covers production-phase verification to ensure that manufactured products conform to the approved type. Annex XI offers two options:

Part A — Quality assurance of production (QMS)​

The notified body assesses the manufacturer's production QMS — covering manufacturing, final inspection, and testing — to verify ongoing conformity with the approved type.

This is similar to the production-focused elements of Annex IX but narrower: it covers manufacturing quality, not the full device design.

Includes:

  • QMS assessment at manufacturing site(s)
  • Periodic surveillance audits (announced and unannounced)
  • Issuance of a quality assurance certificate for production

Part B — Product conformity verification (batch verification)​

The notified body carries out examination and testing of the actual products (or statistical samples) manufactured. The NB verifies that each batch (or a defined sample thereof) conforms to the approved type.

This route provides stronger product-level assurance but is resource-intensive. It is rarely the first choice for high-volume devices but may be appropriate for:

  • Low-volume, high-risk devices
  • Custom or made-to-order devices
  • Situations where manufacturing process control is hard to demonstrate through QMS alone

Official references​

ReferenceDescription
MDR Annex XEU type examination
MDR Annex XIProduct conformity verification (Parts A and B)
IVDR Annex XIVDR EU type examination
IVDR Annex XIIVDR product conformity verification
MDR Art. 52(3)Available procedures by class
MDCG 2020-3Guidance on significant changes