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.

Design control & change assessment & change registration of medical device and IVD

During the product development of medical device manufacturer has to control design change. The process is called changes assessment. The output is to file change assessment, to implement the action and upon significant changes to notify authority in term of change registration in many markets. Then manufacturer could place the changed design in rescriptive markets.

At ISO 13485 it stipulates at chapter 7.3.9.

The organisation shall document procedures to control design and development changes. The organisation shall determine the significant of the change to function, performance, usability, safety and applicable regulatory requirements for the medical device and its intended use.

In this article we want to limit to significant change which shall be informed to notified body or agencies to review. The significant changes on site of manufacturer include also new features or modifications at next generation development of medical device or IVD.

What is significant change of medical device?

Let`s take FDAs oldest guidance as good example. For typical registration type pre-market notification 510(K), it says in 21 CFR 807.81(a)(3) that a premarket notification must be submitted when:

(3) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitute significant changes or modifications that require a premarket notification:

(i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.

(ii) A major change or modification in the intended use of the device

Significant change of medical device can be understood also as major or important changes or modifications to an existing Device.

The key information here at FDA is:

Significant changes are which affect safety or effectiveness of the device
Upon significant changes manufacturer needs an official notification which bears in many country a solid new (change) registration

The typical significant changes are:

Design change (specification)
Control mechanism, operation principle
Intended use
Material
Sterilisation method
Labelling
Critical manufacturing process

Why do we need to notify change of medical device? And to Whom?

Firstly we can categorise changes of device:

Significant changes and non-significant change
From manufacturer, field, supplier or authority
Active change from manufacturer or passive corrective change from all parties

Besides participants of change assessment inside manufacturer, at least significant changes should be notified to

Authority or notified body
Distributor
User

The reason to notify significant change is due to the safety and performance impact of device that above mentioned stakeholder has to know and even review the significant changes. It makes sense that for some design changes, it needs years till change registration is approved.

When should we notify significant change of medical device?

To have evidence of significant changes of device, usually manufacturer has to undergo verification and validation. This role is assigned to R&D often.

The best way to inform distributor or international subsidiary or consulting partner is at the beginning stage of changes when the rough implementation method and impact of changes are foreseen.

The pragmatic way to inform notified body is also as early as possible at early stage of changes. Depending on quick feedback, manufacturer could adjust implementation grad and pace of the changes. Because of regulatory character on noticed body or agency, it is recommended to have solid form to provide details and even comparison table to illustrate the change. Use e.g. pre-submission pre-evaluation possibility to chase the reaction and tips there.

How to notify all kinds of changes of medical device?

If a new change registration is needed, it is better to initial the projects with focused markets. The material to describe significant change in this term is far extensive sometimes as solid technical documentation. The project or preparation of change registration could be also initiated early in parallel with V&V of design change.

In some markets like Australia, a brief process of change request between manufacturer and authority is only needed.

In other market as Canada, manufacturer either submits a new change registration or list semi-significant changes to authority annually.

Below in figure is one typical deciding tree for regulatory affairs to assess the change in Canada.

Actually for all minor or un-significant change, manufacturer has to file all assessment in quality management system. Like for FDA in US, unstructured form and undefined content of “letter to file” without submission is sufficient.

deciding tree of design change in Canada

Typical mistakes and take home message of significant change

Design changes

Not all design changes are significant changes. The key rule is to see the impact of safety and performance. If it was uncritical design change and raised not new risk, just file it in quality management.

Labelling as changes

Either in instruction for use or in label on packaging of medical device or IVD, only change of warning or contraindication or precaution, intended use and critical specifications matter. Rewording is not worthy to mention. All uncritical change on labelling should be integrated with critical labelling changes to next revision.

Quality management system changes

It could be change of manufacturing site, manufacturing process, validation of cleaning room, supplier contract, sub-suppliers, personals, instruments and machines. If it was not described at registration, report or update this only in QM-related markets in next renewal.

Certificate and registration changes

This is oft ignored. In many markets it is critical to change important contents on registration as component, intended use, info of manufacturers or legal representative. Manufacturer has to react upon this kind of changes.

As well for critical chapter of technical documentation, if descriptions or even picture of critical component, shelf life, and packaging validation were changed, it leads oft to new registration.

We real some changes soft skills from our best quality and regulatory practise

Communication of changes

Talking on the same page of product change is not easy in the whole lifecycle of medical device. For critical change, a project leader or change leader should coordinate and monitor all actions.

Even to distributor or user, this person is resource giver for any form to present changes.

Illustration of change

Product change could be very technical. The art is to use plain language to introduce to all stakeholders.

Use picture, workflow, block diagram, comparison table and even video!

Bundle of changes

We assume that critical changes appear often till next product generation, try to bundle all changes at least annually as a bundle to notify authority. It saves uncountable efforts.

Uses change as new features

Change is not that elegant wording and even strange for users. Why not transfer critical product change in a marketing wording to improve the attraction of device?