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Substantial Changes for Design and Quality System: an Overview

The definition of substantial changes has always been very critical for medical device manufacturers. We have already been talking about Design Changes and the management of change control and we have been discussing as well the requirements associated to legacy devices, where the distinction between substantial and non-substantial changes play a foundamental role.

In this article we will go more in details into the meaning of substantial changes, with a particular attention to the European regulation and the NBOG document related to this topic.

Management of Changes: Obligations of the Manufacturer

When dealing with a change, either on the design of a marketed device or a change related to the Quality System of the organization, the manufacturer needs to perform several actions in order to evaluate and implement the specific change.

In fact, specific procedures or working instructions shall be prepared by the manufacturer in order to properly manage specific points such as:

  • Evaluation of the possible change of the product/product range or of the quality system in relation to risk management process
  • Methodologies for the definition of a change implementation plan to monitor the change stages
  • Determination whether the change is substantial or not
  • Submission of the change information to the Notified Body for review
  • Final implementation of the change

Let’s say that in general this is not so different from any other standard change control process for medical device that should be in plance at any manufacturer.

Criteria for Substantial Changes

The criteria for determination of substantial changes are quite complex as they have to take in consideration different aspects. Different types of change are taken in considerations:

  • Product Changes
  • Quality System Changes
  • Changes of the Product Ranges
  • Specific particular changes, such as software modifications, changes in design specifications, materials, etc.

QualityMedDev will made available a specific checklist that can be used to determine whether a specific change is considered substantial or not.

Significant Changes

One of the key article of the EU MDR 2017/745 is definitely article 120 that defines the requirements based on which devices with a valid certificate under the previous Medical Device Directive can stay on the market during the transition period unless a substantial change is implemented on the device.

We have already discussing in details about the Article 120 and the definition of significant changes as per EU MDR 2017/745.

Checklist for Changes Evaluation

QualityMedDev has prepared a specific checklist that may help manufacturers or other personnel involved in Medical Device Business operations to evaluate the significance of a specific change related to product, product range or quality management system. This checklist is available as excel sheet and ready to be downloaded in our QualityMedDev Shop. Do not hesitate to download this product.

QualityMedDev Newsletter

QualityMedDev is an online platform focused on Quality & Regulatory topics for medical device business.

Thanks to QualityMedDev newsletter, you will stay updated with the most recent articles published on the website, along with news from the regulatory world, particularly in the context of the new EU MDR and IVDR.

QualityMedDev is one of the largest online platform supporting medical device business for regulatory compliance topics.

If you have any topic for which you would like to have more information or you need template or documentation that is currently not available in our QualityMedDev Shop, do not hesitate to contact us and we will do our best to fulfil your request.

Recently we introduced our Compliance Kits related to EU MDR 2017/745 and post-market surveillance activities. These compliance kits comprises of different guidelines, ebooks, templates and procedures that are essentials.

Moreover, do not hesitate to look at our EU MDR E-book collecting a vast number of information on topics related to the European Medical Device Regulation.

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