How to Use the EU Declaration of Conformity in Global Markets

Purpose

This guide explains the EU Declaration of Conformity (DoC) for manufacturers of medical device (in vitro diagnostics, IVDs). It shows how to maximize the DoC’s value across product lifecycle stages and international registrations.

Background of the EU Declaration of Conformity

The EU DoC documents that a medical device meets applicable EU requirements and is the legal basis for CE marking. For higher risk devices the DoC is supported by a notified body assessment of the quality management system and, where applicable, technical documentation sampling. Unlike some jurisdictions where regulators issue device approvals in terms of certificate, the DoC places primary responsibility on the manufacturer to demonstrate and maintain compliance.

Key Elements of the DoC

• Product information including device classification and intended use.

• Manufacturer details and legal manufacturer identification.

• Notified body identification when involved.

• Authorised representative details if the manufacturer is outside the EU.

• Signature information: name, role, date, and signature

Validity and Renewal

The DoC remains valid as long as the device continues to comply with applicable EU rules. For devices requiring notified body involvement, certificates are typically subject to periodic renewal and surveillance audits; notified body certificates commonly follow a five‑year cycle but depend on the conformity assessment and the notified body’s processes.

Using the DoC in International Submissions

• Standard evidence: Many regulators accept a legalized DoC together with the manufacturer’s quality system certificate (EC MDR and ISO 13485) as proof of conformity.

• Free sale certificates: Some markets require a free sale certificate or equivalent issued by a competent authority; this is often derived from the DoC or CE evidence.

• Product name and intended use: Align the product name and intended use with the target market’s registration rules. Minor rewording to meet local language or naming conventions is usually acceptable; substantive expansion of intended use is not. Manufacturers can issue a revised DoC to reflect a market‑specific product name or wording.

Managing Significant Changes and Notifications

• Significant change to design, intended use, or performance typically requires a new DoC and may trigger a change registration in the foreign market.

• Non‑significant changes may only require notification to the authority or uby assessing change in own quality system

• Practical approach: Map markets by their change‑management requirements. Cluster markets where a new DoC alone suffices versus those requiring formal re‑registration (=chnage registration), and plan regulatory actions accordingly.

MDD to MDR Transition Considerations

Legacy devices certified under the Medical Devices Directive may benefit from transition periods. Use transition time to:

• Assess whether MDD certificates will be prolonged or need replacement under MDR.

• Obtain notified body statements or transition confirmations that some authorities request during international submissions.

• Update technical documentation and DoC language to align with MDR expectations where relevant.

Practical Recommendations for Global Success

• Treat the DoC as a strategic asset: Use it proactively to open markets where CE evidence is recognized.

• Standardize templates: Maintain a master DoC template and controlled variants for market‑specific names and intended uses.

• Document change rationale: For every product change, record whether it is significant and the regulatory consequence per market.

• Engage notified body early: For changes that may affect conformity assessment, consult your notified body to avoid surprises.

• Plan for translations and legalization: Anticipate language and legalization requirements for target markets to speed submissions.

Takeaway

The EU Declaration of Conformity is more than a compliance document; it is a practical gateway to many global markets. By aligning product names, intended use statements, and change management to each target market’s rules—and by treating the DoC as a living document—manufacturers can accelerate registrations, reduce duplication, and expand product reach efficiently.

Do you know in Australia and Malaysia there is similar DOC with similar scope. Even for registration in some markets a kind of declaration by manufacturer is needed. Learn more in our E-Learning of global regulatory affairs.