EU Declaration of Conformity & CE marking
MDR Art. 19 and Annex IV (Declaration of Conformity); MDR Art. 20 (CE marking). Equivalent IVDR provisions: Art. 17 and Annex IV (DoC); Art. 18 (CE marking).
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.
EU Declaration of Conformity
The EU Declaration of Conformity (DoC) is the manufacturer's formal legal statement that a device meets all applicable MDR or IVDR requirements. It is the culmination of the conformity assessment process.
Who signs it?
The DoC must be signed by the manufacturer — specifically by a person authorised to sign legal documents on behalf of the manufacturer. This is typically the CEO, Managing Director, or a person with delegated authority documented in the QMS.
For non-EU manufacturers, the DoC may also bear the EU authorised representative's countersignature in some member state practices, but the primary obligation rests with the manufacturer.
Mandatory content — MDR Annex IV
The DoC must contain:
| Element | Description |
|---|---|
| Name and address | Legal name and address of the manufacturer |
| EU REP | Name and address of authorised representative (non-EU manufacturers) |
| Declaration statement | "This declaration of conformity is issued under the sole responsibility of the manufacturer" |
| Device identification | Name, model, product/catalogue number, UDI-DI (basic UDI-DI where applicable) |
| Regulation compliance | Statement that the device conforms to MDR 2017/745 (or IVDR 2017/746) |
| Applicable regulations | Reference to any other EU legislation applying to the device (e.g. EMC Directive, Radio Equipment Directive, REACH) |
| Harmonised standards | List of harmonised standards applied, with edition references |
| Common Specifications | List of CS applied, if any |
| NB identification | NB name, address, and identification number; certificate number and date (if NB was involved) |
| Supplement references | Reference to any supplements to this DoC |
| Signatory information | Name, function, date, and signature of the authorised person |
Retention
The DoC must be kept for at least:
- 15 years after the last device was placed on the market (general rule)
- 30 years for implantable devices
The DoC must be made available to competent authorities on request.
The CE mark
The CE mark is the visible signal to the market that the manufacturer has declared conformity with all applicable EU requirements. It must be affixed to the device (or its sterile packaging, or the outer packaging) before the device is placed on the EU market.
CE mark specifications
The CE mark must be reproduced accurately:
- The letters CE in a specific proportional format
- Minimum height: 5mm (unless the device's dimensions prevent this, in which case it may be smaller, but proportions must be maintained)
- The CE mark must be clearly visible, legible, and indelible
What the CE mark includes
The CE mark alone (no NB number) appears for:
- Class I standard devices (self-declaration)
- Class A standard IVDR devices
The CE mark followed by the notified body identification number appears for:
- All devices where a notified body was involved in conformity assessment
- Format: CE [NB number] (e.g. CE 0123)
What the CE mark is — and is not
| The CE mark IS | The CE mark is NOT |
|---|---|
| A regulatory compliance statement by the manufacturer | A quality mark or performance endorsement |
| A statement that all applicable EU legislation requirements are met | A guarantee of safety |
| A requirement for placing the device on the EU market | An approval from a regulator |
| Applicable to all EU markets simultaneously | Country-specific |
Prohibited uses of the CE mark
The CE mark must not be:
- Affixed before all conformity assessment procedures are complete
- Affixed to devices that do not meet all applicable requirements
- Modified, obscured, or accompanied by other markings that could be misleading
- Used in a way that implies a different conformity assessment was performed than what actually occurred
Keeping the DoC current
The DoC is not a static document. It must be updated when:
- The device is modified significantly (new model, material change, software update)
- A new or revised harmonised standard is applied
- The notified body certificate is renewed or a new certificate is issued
- The EU REP changes
- Any other information in the DoC changes
When the DoC is updated, the previous version must be retained in the document control system with its original date and signature.
Summary of safety and clinical performance (SSCP)
For Class III devices and implantable devices (MDR) and Class D IVDs and Class C IVDs listed by Commission implementing acts (IVDR), the manufacturer must also prepare a Summary of Safety and Clinical Performance (SSCP). This is:
- A publicly accessible document uploaded to EUDAMED
- A plain-language summary of the device, its intended purpose, clinical evidence, and safety information
- Validated by the notified body as part of the conformity assessment
- Updated at least annually or when new significant information is available
The SSCP is distinct from the DoC — it is consumer-facing and provides transparency on clinical performance for the public and healthcare professionals.
Related pages
- Conformity assessment — overview
- Annex IX — QMS + Tech Doc
- Annex X — Type examination
- Class I self-declaration
- EUDAMED registration
Official references
| Reference | Description |
|---|---|
| MDR Art. 19 | EU Declaration of Conformity |
| MDR Annex IV | DoC content requirements |
| MDR Art. 20 | CE marking requirements |
| IVDR Art. 17 | IVDR DoC |
| IVDR Annex IV | IVDR DoC content |
| IVDR Art. 18 | IVDR CE marking |
| MDR Art. 32 | Summary of safety and clinical performance (SSCP) |
| MDCG 2019-9 | SSCP guidance |