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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?


Related regulations of notification of change, design change; Substantial change or significant change


US, when to submit a new 510k

Europe, Guidance on significant changes


Canada, Guidance for the Interpretation of Significant Change of a Medical Device

Australia, Changes affecting TGA-issued conformity assessment certificates

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