Declaration of Conformity

The EU Declaration of Conformity (DoC) is a mandatory document required under EU MDR Article 19 in which the manufacturer formally declares that the medical device complies with all applicable requirements of the EU Medical Device Regulation. The DoC is essential for affixing CE marking and placing the device on the EU market.

Legal basis:
- EU MDR 2017/745 Article 19
- Annex IV specifies required content
- Required for all device classes (I, IIa, IIb, III)
- Must be issued before CE marking is affixed

Required content of DoC:

1. Device identification:
- Product name, model, variant
- Basic UDI-DI (Unique Device Identifier)
- Intended purpose
- Risk classification
- Reference to harmonized standards or common specifications used

2. Manufacturer information:
- Name and registered address
- Single Registration Number (SRN) from EUDAMED
- Contact details
- Person responsible for regulatory compliance (PRRC)

3. Authorized representative (if applicable):
- Name and address within EU
- SRN from EUDAMED

4. Conformity assessment information:
- Reference to relevant conformity assessment procedure
- Notified Body details (name, NB number, certificate reference)
- For Class I devices: statement of self-assessment

5. Applicable regulations and standards:
- Declaration that device complies with EU MDR 2017/745
- Reference to harmonized standards applied (e.g., ISO 13485, IEC 60601)
- Reference to common specifications (if applicable)
- List of other EU regulations with which device complies

6. Signature and date:
- Signed by authorized person on behalf of manufacturer
- Name and function of signatory
- Place and date of issue

When DoC must be drawn up:
- Before affixing CE marking
- After successful conformity assessment
- Before placing device on market
- Separate DoC for each device type/model or can cover device family

Multiple devices and families:
A single DoC may cover:
- Multiple device variants with same intended purpose
- Device families with similar design and manufacturing
- Devices covered by same technical documentation
Must clearly identify all products covered

Relationship to CE marking:
- DoC is prerequisite for CE marking
- CE marking can only be affixed after DoC is issued
- DoC demonstrates legal compliance supporting CE mark
- Without valid DoC, CE marking is not permitted

Retention requirements:
- Must be kept for at least 10 years after last device placed on market
- For implantable devices: 15 years minimum
- Must be available for competent authorities upon request
- Must be continuously updated if device changes

Language requirements:
- Must be in one of the official EU languages
- Some member states may require national language version
- English is commonly used but not universally accepted
- Check specific country requirements

Updates and revisions:
When DoC must be updated:
- Changes to device design or specifications
- New or updated harmonized standards applied
- Change in Notified Body or certificate
- Change in manufacturer details or SRN
- Regulatory requirement changes
- New device variants added to family

DoC for different conformity routes:

Class I (self-certification):
- Manufacturer drafts and signs DoC
- No Notified Body involvement required
- Based on internal conformity assessment
- Manufacturer takes full responsibility

Class IIa, IIb, III (Notified Body required):
- DoC references Notified Body certificate
- Includes NB identification number
- References certificate number and validity
- DoC issued after receiving NB certificate

Common mistakes to avoid:
- Incorrect or outdated device identification
- Missing or incorrect UDI-DI
- Not updating DoC when device changes
- Missing authorized representative details
- Incomplete list of applicable standards
- Incorrect conformity assessment route stated
- Missing signature or unauthorized signatory
- Not maintaining DoC for required period

DoC in technical documentation:
- DoC is part of technical documentation
- Must be included in Annex II or III documentation
- Reviewed during Notified Body assessment
- Checked during regulatory inspections

Verification by other economic operators:

Importers must verify:
- DoC exists and is valid
- DoC matches device being imported
- All required information is present

Distributors must verify:
- DoC is available from manufacturer
- Device covered by valid DoC

Market surveillance:
Authorities may request DoC to:
- Verify CE marking validity
- Check compliance claims
- Investigate suspected non-compliance
- Conduct market surveillance activities

Consequences of missing or invalid DoC:
- Device cannot legally bear CE marking
- Device cannot be placed on EU market
- Potential enforcement actions by authorities
- Product recalls may be required
- Financial penalties possible
- Reputational damage

DoC vs other declarations:

DoC vs Technical Documentation:
- DoC is summary declaration of compliance
- Technical documentation contains detailed evidence
- DoC references technical documentation

DoC vs Certificate of Conformity:
- DoC issued by manufacturer
- Certificate issued by Notified Body
- Both may be required for higher-class devices

DoC vs Declaration of Performance:
- DoC for medical devices under MDR
- Declaration of Performance for construction products (separate regulation)

Best practices:
- Use standardized DoC template (available from EU)
- Implement document control procedures
- Regular review and update schedule
- Training for personnel drafting DoC
- Quality checks before signing
- Secure storage and backup copies
- Version control for revisions
- Audit trail of changes

Digital vs paper DoC:
- Electronic format acceptable
- Must include electronic signature if digital
- PDF format commonly used
- Must be readily available and printable
- Same legal validity as paper version

The EU Declaration of Conformity is a critical regulatory document that serves as the manufacturer's formal commitment that their medical device meets all EU requirements. It is legally required for CE marking and demonstrates compliance to regulators, customers, and other stakeholders.