Class I self-declaration pathway (MDR)
MDR Art. 52(7) and Annex IV. Class I devices (standard) do not require notified body involvement. The manufacturer self-declares conformity by signing an EU Declaration of Conformity after completing all required steps.
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.
Which devices use self-declaration?
The self-declaration pathway applies to MDR Class I (standard) devices — those that are not:
- Supplied in a sterile state (Class Is)
- Incorporating a measuring function (Class Im)
- Reusable surgical instruments (Class Ir)
Examples of Class I standard: non-sterile wound dressings, non-sterile examination gloves, walking aids, stethoscopes, tongue depressors, patient hoists.
What self-declaration requires
Despite no notified body involvement, Class I self-declaration is a substantive process. The manufacturer must:
1. Compile full technical documentation
Full Annex II (pre-market) and Annex III (post-market) technical documentation is required for Class I devices. There is no reduced documentation pathway.
2. Implement a quality management system
MDR Art. 10(9) requires manufacturers to implement a QMS covering all aspects of design, manufacture, and post-market activities. For Class I manufacturers, the QMS does not need to be assessed by a notified body, but must still comply with the principles of EN ISO 13485:2016.
3. Complete the GSPR assessment
A full GSPR cross-reference table must be prepared demonstrating conformity with all applicable Annex I requirements.
4. Conduct a clinical evaluation
A clinical evaluation (Art. 61, Annex XIV) is required for all MDR devices — including Class I. For simple Class I devices, the clinical evaluation may be brief and rely primarily on literature, but it cannot be omitted.
5. Register in EUDAMED
Class I manufacturers must register as economic operators in EUDAMED (obtaining an SRN) and register their devices (UDI registration).
6. Sign the EU Declaration of Conformity
The manufacturer signs an EU Declaration of Conformity (per MDR Annex IV) affirming all applicable requirements have been met. The person signing must be authorised to do so by the manufacturer.
7. Affix the CE mark
Once the Declaration of Conformity is signed, the CE mark may be affixed. The CE mark must be accompanied by the NB identification number only where a notified body was involved — for standard Class I, the CE mark appears without an NB number.
Class Is / Im / Ir — partial notified body involvement
For the sub-classes, a notified body must be involved for specific aspects:
| Sub-class | NB assesses | NB certificate covers |
|---|---|---|
| Class Is (sterile) | Establishment, securing, and maintenance of sterile conditions | Sterility aspects under Annex IX §1 or Annex XI Part A |
| Class Im (measuring) | Conformity of the metrological aspects | Measuring function aspects |
| Class Ir (reusable surgical instrument) | Reprocessing aspects — cleaning, disinfection, sterilisation instructions | Reprocessing validation |
For the remaining aspects of the device (beyond the NB's scope), the manufacturer self-declares.
The NB issues a partial certificate covering only the assessed aspects. The manufacturer then self-declares for everything else. Both are reflected in the EU Declaration of Conformity.
Class A self-declaration (IVDR)
The IVDR Class A self-declaration pathway is structurally equivalent to MDR Class I. It applies to the lowest-risk IVDs (general laboratory instruments, specimen receptacles, buffers and solutions, general stains).
Requirements parallel MDR Class I:
- Full technical documentation (Annex II + III)
- QMS covering all relevant activities
- Full GSPR/performance evaluation
- EUDAMED registration
- EU Declaration of Conformity (IVDR Annex IV)
- CE mark (without NB number)
Class A sterile devices require partial NB involvement for sterility aspects — analogous to MDR Class Is.
Responsibilities after self-declaration
Self-declaration does not end manufacturer obligations. Class I manufacturers remain responsible for:
- Post-market surveillance — PMS plan, PMS reports, and responding to vigilance data
- Vigilance reporting — serious incidents must be reported to NCAs
- EUDAMED maintenance — keeping device and operator registration current
- Technical documentation maintenance — updating documentation when the device changes
- Complaints handling — investigating and responding to user complaints
Competent authorities can and do inspect Class I manufacturers. Non-compliant Class I devices are subject to market surveillance actions including recalls and suspension from the market.
Common mistakes in Class I self-declaration
| Mistake | Consequence |
|---|---|
| Skipping clinical evaluation | Technically non-compliant; clinical evaluation is mandatory for all classes |
| No formal GSPR table | Missing required technical documentation element |
| EUDAMED registration omitted | Regulatory non-compliance; devices cannot lawfully be on the market |
| QMS is informal or undocumented | Risk of NCA finding; not defensible in a market surveillance inspection |
| Declaration of Conformity not retained | Must be made available to NCAs on request |
Related pages
- Conformity assessment — overview
- EU Declaration of Conformity
- CE marking requirements
- Class I · IIa · IIb · III
- EUDAMED registration
Official references
| Reference | Description |
|---|---|
| MDR Art. 52(7) | Class I conformity assessment |
| MDR Annex IV | EU Declaration of Conformity |
| MDR Art. 10(9) | QMS requirements |
| MDR Art. 61 | Clinical evaluation (all classes) |
| IVDR Art. 48(7) | Class A conformity assessment |
| MDCG 2021-22 | Guidance on Class I registration |