EU Declaration of Conformity (DoC) for Medical Devices: Complete Template Guide with 2026 Language and Digital Requirements

The Declaration of Conformity Is Your Legal Passport to the EU Market

The EU Declaration of Conformity (DoC) is not just another document in your technical file — it is the legally binding instrument by which the manufacturer formally declares that a medical device meets all applicable requirements of Regulation (EU) 2017/745 (MDR). Without a valid DoC, you cannot affix the CE mark, you cannot place your device on the EU market, and you cannot legally sell a single unit in any EU Member State.

The DoC is explicitly required by Article 19 of the MDR, and its minimum content is defined in Annex IV. The regulation is prescriptive about what must be included, how it must be maintained, and which languages it must be available in. Getting this wrong is not a minor documentation issue — it is a regulatory violation that can trigger product recalls, market withdrawal, and enforcement action by Competent Authorities.

This guide covers every element of a compliant DoC under the MDR, provides an annotated template, explains the language requirements per Member State, addresses legacy device considerations under Regulation (EU) 2023/607, and incorporates the latest 2026 developments including the European Commission's proposal for digital Declarations of Conformity.

What Is the Declaration of Conformity?

The Declaration of Conformity is the manufacturer's formal statement that a device conforms to the requirements of the MDR and all other applicable EU legislation. It is:

• A legal commitment, not a self-congratulatory note. By signing it, the manufacturer assumes full legal responsibility for device compliance.
• A living document, not a one-time filing. Article 19 requires the manufacturer to "continuously update" the DoC throughout the device's market life.
• Part of the technical documentation, not a separate filing. It must be available for review by Notified Bodies and Competent Authorities at any time.
• Required for all device classes, from Class I through Class III. Even self-certified Class I devices need a DoC.

The DoC concept is not new — it existed under the old Medical Device Directive (MDD 93/42/EEC) and Active Implantable Medical Device Directive (AIMDD 90/385/EEC). However, the MDR significantly expanded the minimum content requirements and added new elements such as the Basic UDI-DI and specific references to the conformity assessment procedure followed.

Legal Basis: Article 19 and Annex IV

Article 19 — Key Provisions

Article 19 of the MDR establishes four fundamental requirements:

1. The EU declaration of conformity shall state that the requirements specified in the MDR have been fulfilled in relation to the device covered.
2. The manufacturer shall continuously update the EU declaration of conformity.
3. The EU declaration of conformity shall contain the minimum information set out in Annex IV and be translated into the official Union language(s) required by the Member State(s) where the device is made available.
4. Where a device is subject to other EU legislation that also requires a declaration of conformity, a single EU declaration of conformity shall be drawn up covering all applicable Union acts.
5. The Commission may adopt delegated acts (per Article 115) to amend the minimum content of Annex IV in light of technical progress.

Annex IV — Minimum Content Requirements

Annex IV specifies exactly what must appear in every DoC. The required elements are:

1. Name and address of the manufacturer (or authorized representative if the manufacturer is outside the EU)
2. Single Registration Number (SRN) of the manufacturer
3. Basic UDI-DI of the device(s) covered
4. Device identification: product name, trade name, product code, catalogue number, or other unambiguous reference, plus intended purpose
5. Risk class as determined by Annex VIII, and the applicable classification rule(s)
6. Conformity assessment procedure followed (specific Annex references)
7. Name and identification number of the Notified Body (if applicable), and the certificate number(s) issued
8. Statement of conformity: "The device described above is in conformity with Regulation (EU) 2017/745"
9. References to harmonised standards or common specifications applied
10. References to other EU legislation the device complies with (e.g., RoHS, EU Cyber Resilience Act)
11. Place, date, and signature of the authorized person
12. Name and function of the person authorized to sign on behalf of the manufacturer

Complete Annotated DoC Template

Below is a fully annotated template that meets all Annex IV requirements. Copy this structure and fill in the bracketed fields.

EU DECLARATION OF CONFORMITY

1. Manufacturer
   Name: [Full legal entity name]
   Address: [Full registered address including country]
   SRN: [Single Registration Number from EUDAMED]

2. Authorized Representative (if manufacturer is outside EU)
   Name: [Full legal entity name of EC REP]
   Address: [Full registered address]
   SRN: [EC REP SRN from EUDAMED]

3. Device Identification
   Product/Trade Name: [Device name]
   Product Code: [Internal product code]
   Catalogue Number: [Catalogue number]
   Basic UDI-DI: [Basic UDI-DI as assigned]
   Intended Purpose: [Brief description matching the device's
                      intended purpose in the technical documentation]

4. Risk Classification
   Device Class: [I / Is / Im / Ir / IIa / IIb / III]
   Classification Rule(s): [e.g., "Rule 8" or "Rules 8 and 14"]
   Classification per Annex VIII of Regulation (EU) 2017/745

5. Conformity Assessment Procedure
   [Select and complete the applicable procedure:]

   For Class I devices (self-certification):
   "The conformity assessment procedure was carried out in accordance
   with Article 52(7) of Regulation (EU) 2017/745."

   For Class IIa, IIb, III devices:
   "The conformity assessment procedure was carried out in accordance
   with Annex [IX / XI Part A / XI Part B] of Regulation (EU) 2017/745."

   Notified Body: [Name]
   Notified Body Number: [4-digit identification number]
   EU Type Examination Certificate: [Certificate number and date]
   Quality Management System Certificate: [Certificate number and date]

6. Statement of Conformity
   The device(s) described above is/are in conformity with the
   requirements of Regulation (EU) 2017/745 of the European Parliament
   and of the Council of 5 April 2017 on medical devices.

7. Applied Harmonised Standards and Common Specifications
   [List all standards with full references:]
   - EN ISO 13485:2016+A11:2021 (Quality management systems)
   - EN ISO 14971:2019+A11:2021 (Risk management)
   - EN IEC 62304:2006+A1:2015+A2:2020 (Software lifecycle)
   - [Additional standards specific to the device]

8. Other Applicable EU Legislation
   - Directive 2011/65/EU (RoHS) as amended
   - Regulation (EU) 2023/1230 on machinery (if applicable)
   - [Other applicable legislation]

9. Authorized Signatory
   Signed for and on behalf of: [Manufacturer name]

   Place: [City, Country]
   Date: [DD/MM/YYYY]

   Name: [Full name]
   Function: [Title/Role, e.g., "Head of Regulatory Affairs"]
   Signature: [Signature]

Language Requirements by EU Member State

The MDR requires the DoC to be translated into the official Union language(s) determined by each Member State where the device is made available. This is not optional — failure to provide a DoC in the required language is a regulatory violation.

DoC Language Requirements Table

Practical Approach to Language Compliance

Manufacturers selling across the EU typically prepare their master DoC in English, then translate into the required languages for each target market. For practical management:

1. Maintain a master English DoC with version control
2. Create translations as separate documents linked to the master version
3. Use the same translation process as for IFUs (Instructions for Use) to ensure consistency
4. Some Member States accept English for professional-use devices — verify the specific requirements for each market
5. The DoC translation obligation is separate from, and in addition to, IFU and labeling translation requirements

Legacy Device Considerations Under Regulation (EU) 2023/607

Devices that were certified under the MDD or AIMDD and benefit from the extended transition timelines face specific DoC requirements. MDCG 2021-25 (as revised) clarifies:

• Legacy devices with valid MDD/AIMDD certificates: The existing DoC remains valid, but it must reference the original directive (not the MDR). You cannot issue an MDR DoC for a device that has not undergone MDR conformity assessment.
• Legacy devices with DoCs drawn up before May 26, 2021 (Class I up-classified): These devices may continue to be placed on the market under the transition provisions, but the manufacturer must have a QMS compliant with MDR Article 10(9) and must comply with MDR vigilance and PMS requirements.
• When updating the DoC for non-significant changes: The manufacturer should add a reference to the original DoC and ensure traceability of all versions. An updated DoC does not change the underlying conformity assessment basis.
• DoC must not claim MDR compliance for a legacy device unless the device has undergone full MDR conformity assessment.

Manufacturer's Declaration Template (Regulation 2023/607)

MedTech Europe has published a joint template for the manufacturer's declaration required under Regulation 2023/607. This template consists of two parts:

1. A text section with selectable declarations confirming compliance with the transition conditions
2. A schedule listing the devices covered

This is a separate document from the DoC itself and is used to demonstrate eligibility for the extended transition timelines.

Conformity Assessment Routes and DoC Content

The content of your DoC changes depending on the conformity assessment route you followed. Here is how each route maps to DoC requirements:

For Class IIb active devices intended to administer or remove medicinal products, and Class III implantable devices, the Notified Body must also involve an expert panel for clinical evaluation consultation. This additional step should be reflected in your conformity assessment documentation and, where relevant, in the DoC's referenced certificates.

Record Retention Requirements

The DoC must be maintained by the manufacturer for the entire period the device is on the market, plus:

For devices with ongoing market presence, this means you must maintain a continuously updated DoC for the entire commercial lifetime of the product plus the retention period. Importers must also keep a copy of the DoC for the same period.

2026 Developments: Digital DoC and EUDAMED

European Commission's Digital DoC Proposal (December 2025)

The European Commission's December 2025 simplification package includes a provision allowing the EU Declaration of Conformity to be provided in digital form in the future, subject to implementing rules. While paper/traditional formats remain the current requirement, this change signals a shift toward digital compliance documentation.

Manufacturers building or upgrading document management systems should plan for:

• Digital DoC generation and storage capabilities
• Electronic signature workflows that meet EU eIDAS requirements
• Version control systems that maintain full audit trails
• Integration with EUDAMED for device registration

EUDAMED Mandatory Registration (May 28, 2026)

From May 28, 2026, EUDAMED registration becomes mandatory for new devices. While the DoC itself is not uploaded to EUDAMED, the system requires registration of information that appears on the DoC, including:

• Basic UDI-DI
• Device class and classification rule
• Notified Body details and certificate numbers
• Manufacturer SRN

Consistency between your DoC and EUDAMED entries is critical. Competent Authorities will cross-reference these during market surveillance.

Harmonised Standards Update (EU 2026/193)

The updated list of harmonised standards published in Implementing Decision (EU) 2026/193 means manufacturers should review the standards listed on their DoC. If a previously referenced standard has been superseded or updated, the DoC should be updated to reflect the current version.

DoC for Special Device Categories

Custom-Made Devices

Custom-made devices do not require a DoC in the traditional sense. Instead, the manufacturer draws up a statement per Annex XIII that includes similar information but acknowledges the custom-made nature of the device. This statement must be available to the relevant national competent authority.

System and Procedure Packs

Manufacturers of systems or procedure packs draw up a declaration per Article 22(1)-(4) stating that:

• Each device in the pack has been CE marked and is used within its intended purpose
• The combination of devices is safe and compatible
• The activity falls within the scope of the manufacturer's activities

Devices Without Medical Purpose (Annex XVI)

Products listed in Annex XVI (aesthetic/cosmetic devices) require a full DoC just like any medical device, because they are treated as medical devices for regulatory purposes under the MDR.

Common DoC Mistakes and Audit Findings

Notified Bodies and Competent Authorities frequently cite these DoC deficiencies during audits:

1. Missing or incorrect Basic UDI-DI. This is a new MDR requirement that does not exist under the MDD. Many manufacturers initially omit it or use the wrong UDI type. The Basic UDI-DI is a device family-level identifier, not the unit-level UDI-DI.

2. Outdated harmonised standards references. Standards on the DoC must match the version actually applied and the current list of harmonised standards. Using outdated standard versions or listing standards not relevant to the device is a common finding.

3. Incomplete classification information. The DoC must specify both the class and the applicable classification rule(s) from Annex VIII. Omitting the rule number is insufficient.

4. Missing translations. Selling in a Member State without a DoC in the required language is an immediate non-conformity. Track where each device is sold and ensure translations exist for all markets.

5. Not continuously updating the DoC. The DoC is a living document. Any change to the device, applicable standards, certificates, or conformity assessment basis must trigger a DoC review and potential update.

6. Mixing MDD and MDR references. Legacy devices must reference the MDD, not the MDR. New devices must reference the MDR, not the MDD. Mixing references creates confusion and audit findings.

7. Missing SRN. The Single Registration Number is required on every MDR DoC. It is obtained through EUDAMED actor registration.

DoC vs. Other Regulatory Documents

FAQ

Is a Declaration of Conformity required for Class I devices?

Yes. All devices, including Class I, require a DoC. Class I devices can self-certify, meaning the manufacturer draws up the DoC without Notified Body involvement, but the document is still legally required and must meet all Annex IV content requirements.

Can one DoC cover multiple devices?

Yes. A DoC may cover multiple devices that share the same Basic UDI-DI, or it can group multiple Basic UDI-DIs. The key requirement is that every device on the DoC is clearly identifiable with its product name, code, catalogue number, and class.

How often must the DoC be updated?

The MDR requires "continuous updating" — there is no fixed schedule. You must review and update the DoC whenever there is a change to the device, its classification, the conformity assessment basis, the applicable standards, the Notified Body certificates, or the manufacturer's details. Best practice is to review the DoC at least annually as part of management review.

What happens if a Notified Body certificate is renewed or reissued?

The DoC must be updated to reference the new certificate number and date. The old certificate reference should be archived for traceability. This is a common trigger for DoC updates that manufacturers sometimes overlook.

Does the DoC need to be provided with every device shipped?

No. The DoC does not need to physically accompany each device. However, it must be part of the technical documentation and available to Competent Authorities upon request. Importers must keep a copy. Some manufacturers choose to make the DoC available on their website for transparency.

Can the DoC be signed electronically?

Currently, the MDR does not explicitly address electronic signatures for the DoC. The December 2025 European Commission proposal includes provisions for digital DoCs, but until implementing rules are adopted, the safest approach is a wet-ink signature. If using electronic signatures, ensure they meet eIDAS requirements for qualified electronic signatures.

What is the difference between the DoC and the CE mark?

The CE mark is the visual symbol affixed to the device and its packaging indicating conformity. The DoC is the legal document behind the CE mark. You cannot affix the CE mark without first having drawn up the DoC. They are complementary — the CE mark is what the market sees, the DoC is what authorities review.

How does the DoC differ for IVDR devices?

The structure is similar, but the legal basis changes to Regulation (EU) 2017/746 (IVDR), Article 17, and Annex IV of the IVDR. Classification references the IVDR classification rules (Classes A, B, C, D) rather than MDR classes. Otherwise, the content structure and obligations are parallel.

Do I need a separate DoC for RoHS compliance?

No. Article 19(2) requires that if a device is subject to multiple EU legislation requiring declarations of conformity, a single DoC must be drawn up covering all applicable legislation. You should list RoHS and any other applicable directives/regulations in the "Other Applicable EU Legislation" section of a single combined DoC.