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.
-
Change Control Template€64,00 -
Change Control Procedure€64,00
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.
4EasyReg 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
4EasyReg 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 4EasyReg Shop. Do not hesitate to download this product.
Subscribe to 4EasyReg Newsletter
4EasyReg is an online platform dedicated to Quality & Regulatory matters within the medical device industry. Have a look to all the services that we provide: we are very transparent in the pricing associated to these consulting services.
Within our WebShop, a wide range of procedures, templates, checklists are available, all of them focused on regulatory topics for medical device compliance to applicable regulations. Within the webshop, a dedicated section related to cybersecurity and compliance to ISO 27001 for medical device organizations is also present.
As one of the leading online platforms in the medical device sector, 4EasyReg offers extensive support for regulatory compliance. Our services cover a wide range of topics, from EU MDR & IVDR to ISO 13485, encompassing risk management, biocompatibility, usability, software verification and validation, and assistance in preparing technical documentation for MDR compliance.
Do not hesitate to subscribe to our Newsletter!
