Conformity assessment — overview & route selection
MDR conformity assessment procedures are set out in MDR Art. 52 and Annexes IX–XI. IVDR equivalents are in IVDR Art. 48 and Annexes IX–XI. The EU Declaration of Conformity is required under MDR Art. 19 / IVDR Art. 17 and MDR Annex IV / IVDR Annex IV.
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 conformity assessment?
Conformity assessment is the process by which a manufacturer demonstrates — either alone or with a notified body — that a device meets all applicable MDR or IVDR requirements. Successful conformity assessment results in:
- An EU certificate (where a notified body is involved)
- An EU Declaration of Conformity (signed by the manufacturer)
- The right to affix the CE mark
Conformity assessment is not a one-time event — certificates have defined validity periods and are subject to surveillance audits. The conformity assessment obligation continues throughout the device's commercial life.
The available conformity assessment routes
MDR and IVDR offer three main procedures, defined in Annexes IX, X, and XI:
| Annex | Procedure | Description |
|---|---|---|
| Annex IX | QMS + Technical Documentation Assessment | Notified body assesses the manufacturer's QMS and technical documentation for representative devices |
| Annex X | EU Type Examination | Notified body examines and tests a representative specimen (the "type") of the device |
| Annex XI | Product Conformity Verification | Notified body verifies that manufactured products conform to the approved type or QMS |
Annex X and XI are used together — Annex X establishes the "type" and Annex XI verifies production against it.
Annex IX can be used alone (QMS + tech doc) or combined with Annex X for the type examination element.
Which route applies — by device class
MDR
| Class | Available routes | Notified body required? |
|---|---|---|
| Class I (standard) | Self-declaration (no Annex procedure needed) | No |
| Class Is / Im / Ir | Partial Annex IX or XI (Part A) for specific aspects only + self-declaration for remainder | Yes — for sterility / measuring / reprocessing aspects only |
| Class IIa | Annex IX, or Annex X + Annex XI (Part A or B) | Yes |
| Class IIb | Annex IX, or Annex X + Annex XI (Part A or B) | Yes |
| Class III | Annex IX only | Yes |
IVDR
| Class | Available routes | Notified body required? |
|---|---|---|
| Class A (non-sterile) | Self-declaration | No |
| Class A (sterile) | Partial NB involvement for sterility aspects | Yes — sterility aspects only |
| Class B | Annex IX, or Annex X + Annex XI (Part A or B) | Yes |
| Class C | Annex IX, or Annex X + Annex XI (Part A or B) | Yes |
| Class D | Annex IX only + EU reference laboratory review | Yes |
Route selection considerations
Where a choice exists (e.g. Class IIa may use Annex IX or Annex X + XI), the decision depends on:
| Factor | Annex IX preference | Annex X + XI preference |
|---|---|---|
| Multiple device variants | ✅ QMS approach covers the whole range | Can be burdensome — type exam for each variant |
| Stable, well-defined product | Either | ✅ Type examination well-suited |
| Frequent design changes | ✅ QMS + change control process | Each change may need a new type exam |
| Manufacturing variability concerns | ✅ QMS surveillance covers production | ✅ Product verification checks batches |
| Novel technology | Either | ✅ Type examination allows focused NB review |
Most manufacturers of complex devices with multiple variants or continuous improvement processes choose Annex IX for its flexibility.
The Art. 54 scrutiny procedure
For certain higher-risk devices, an additional layer of scrutiny is required before a notified body can issue or renew a certificate:
| Trigger | Scrutiny mechanism |
|---|---|
| Class III implantable devices (new, without established clinical record) | NB must consult an expert panel for a scientific opinion on the clinical evaluation |
| Class IIb active devices in contact with heart/CNS/central circulatory system (long-term) | Same expert panel consultation |
| Class III devices where NB has doubts | NB may voluntarily seek expert panel opinion |
The expert panel opinion is not binding on the notified body but must be taken into account and any departure from it must be justified.
Timeline considerations
Conformity assessment timelines vary significantly by:
- Device class — Class III/IVDR Class D can take 12–36 months with current notified body capacity constraints
- Notified body — capacity varies; some NBs have waitlists for new applications
- Technical documentation completeness — incomplete submissions extend timelines substantially
- Novel technology — first-in-class devices or those requiring expert panel consultation take longer
Current capacity situation: the transition from MDD/IVDD to MDR/IVDR significantly reduced the number of designated notified bodies, creating a backlog. Manufacturers should engage with notified bodies early — ideally 12–24 months before intended certification.
Related pages
- Annex IX — QMS + tech doc assessment
- Annex X — EU type examination
- Annex XI — Product verification
- Class I self-declaration
- Class A self-declaration (IVDR)
- EU Declaration of Conformity
- CE marking requirements
- Notified bodies
Official references
| Reference | Description |
|---|---|
| MDR Art. 52 | Conformity assessment procedures |
| IVDR Art. 48 | IVDR conformity assessment procedures |
| MDR Annex IX | QMS-based conformity assessment |
| MDR Annex X | EU type examination |
| MDR Annex XI | Product conformity verification |
| MDR Art. 54 | Special procedure for Class III and IIb |
| MDCG 2020-11 | Guidance on conformity assessment procedure selection |