A Declaration of Conformity for a medical device is more than a standard regulatory form, it’s the legal backbone of EU MDR and IVDR compliance. For manufacturers navigating CE marking and European market access, the Declaration of Conformity (DoC) represents your final, public commitment that your device meets all applicable safety, performance, and quality requirements.
Because regulators and notified bodies expect precision, even minor errors in a DoC can trigger delays, rework, or stalled submissions. This guide breaks down everything manufacturers need to know about EU MDR Declarations of Conformity, common pitfalls, and best practices for staying compliant.
What Is a Declaration of Conformity?
A Declaration of Conformity (DoC) is a legally binding document issued by the manufacturer stating that a medical device fully complies with applicable EU legislation; typically the EU MDR (2017/745) for medical devices or IVDR (2017/746) for in vitro diagnostic devices.
Unlike a Certificate of Conformity, which is issued by a notified body, the DoC is self-declared. By signing it, the manufacturer assumes full responsibility that the device meets all relevant conformity assessment, safety, and performance requirements.
Functionally, the DoC serves three purposes:
- Legal attestation of MDR/IVDR compliance
- Prerequisite for CE marking
- Publicly available evidence for authorities, distributors, and end users
Think of the DoC as your final regulatory “green light” before a device reaches the EU market.
When Do You Need a DoC?
A Declaration of Conformity is required before affixing the CE mark and before placing any medical device or IVD on the EU market.
This applies to:
- New devices undergoing MDR/IVDR conformity assessment
- Legacy devices transitioning from MDD/AIMDD to MDR
- Self-certified Class I devices
- Devices involving notified bodies (Class IIa, IIb, III; Class A sterile, B, C, D IVDs)
- System and procedure packs (per MDR Article 22)
Under MDR and IVDR, the DoC must be:
- Updated continuously as applicable requirements or standards change
- Retained for 10 years after the last device is placed on the market (15 years for implantables)
- Available to authorities upon request without delay
Because EU regulators prioritize transparency and traceability, having a clearly maintained and version-controlled DoC is essential for compliance.
Key Elements of a Medical Device Declaration of Conformity
Although formats vary, the MDR and IVDR outline required components every DoC must include.
A compliant EU Declaration of Conformity for medical devices typically contains:
1. Manufacturer Details
- Legal manufacturer name
- Address and contact information
- Authorized Representative (for non-EU manufacturers)
2. Device Identification
- Device name and description
- UDI-DI
- Basic UDI-DI
- Risk class
- Model or catalog numbers
3. Conformity Statement
A formal statement that the device meets all relevant requirements of:
- EU MDR (2017/745) or
- IVDR (2017/746)
This includes referencing applicable annexes for the conformity route taken.
4. Standards and Common Specifications Used
Manufacturers must list:
- Harmonized standards (EN ISO standards)
- Common Specifications (CS)
- Any other recognized state-of-the-art standards supporting conformity
5. Notified Body Information (When Applicable)
For devices requiring NB involvement, the DoC must reference:
- NB name and number
- Certificates issued
- Conformity assessment annexes applied
6. Signatory Information
- Name and title of authorized signatory
- Signature
- Location and date
Each of these elements demonstrates traceability, accountability, and alignment with EU regulatory expectations.
Common Mistakes & Pitfalls in DoCs
Even experienced regulatory teams can run into problems when preparing a Declaration of Conformity. Some of the most common issues include:
Using Outdated Directives or Standards: Manufacturers sometimes reference obsolete MDD/AIMDD directives or outdated harmonized standards; a major red flag for notified bodies.
Missing or Incorrect Translations: DoCs must be available in an EU language required by the Member State where the device is marketed. Missing translations can delay submissions or inspections.
Incomplete Information: Frequent gaps include…
- Missing UDI-DI
- Incorrect device risk class
- Not listing all applied standards
- No designated signatory
Incorrect Notified Body Details: Especially during transitions or renewals, NB certificates and numbers may change and inconsistencies can invalidate the DoC.
Poor Version Control: Duplicate versions or outdated revisions can cause compliance confusion during audits or market surveillance.
Best Practices for Staying Fully Compliant
Creating a compliant medical device DoC is not just a check-the-box exercise, it’s a foundational regulatory asset.
To strengthen accuracy and reduce risk, manufacturers should adopt several best practices:
1. Use a Standardized Template: Consistent formatting helps prevent omissions and supports rapid updates. Many companies maintain a master DoC template aligned with MDR Article 19 and Annex IV.
2. Implement Version Control: Use structured document management systems to track and ensure your CE marking Declaration of Conformity stays current.
- Revisions
- Supporting certificates
- Standard updates
3. Monitor MDR/IVDR and Standards Updates: Harmonized standards evolve frequently. Assign ownership for regularly reviewing EN updates and Common Specifications.
4. Prepare for Translations Early: If your device is marketed across multiple EU countries, translation preparation should happen before final signature, not after.
5. Keep Technical Documentation Tight: Your DoC must always align with your, any mismatch can raise questions during audits or surveillance:
- Technical file
- Design dossier
- Risk management file
- Performance and safety evidence
Conclusion
A Declaration of Conformity for a medical device is a crucial legal document tying together all aspects of MDR/IVDR compliance. Getting it right ensures smooth CE marking, faster market access, and fewer regulatory surprises.
With the right processes of structured templates, version control, clear translations, and strong document management, manufacturers can stay compliant and avoid costly delays.
Stay compliant and avoid costly delays with smarter document management.
FAQ: Medical Device Declaration of Conformity
Q1: What is a Declaration of Conformity for medical devices?
A Declaration of Conformity (DoC) is a legal document in which a manufacturer states that a medical device complies with EU MDR/IVDR requirements and is eligible for CE marking.
Q2: What should be included in an MDR Declaration of Conformity?
A DoC must include manufacturer information, device identification, conformity statements, applied standards, notified body details (if applicable), and signature/date.
Q3: What is the difference between a Declaration of Conformity and a Certificate of Conformity?
A DoC is self-issued by the manufacturer. A Certificate of Conformity is issued by a notified body following a conformity assessment.
Q4: When do medical devices need a Declaration of Conformity?
A DoC is required before affixing the CE mark and placing a device on the EU market.
