MDCG 2020-3 Rev.1: The art of correctly classifying changes – Significant change or not?
Change requests or modifications for existing medical devices under the Device Directive/ Active/Implantable Medical Device Directive (MDD/AIMMD) present a complex challenge for many medical device manufacturers, especially when it comes to maintaining MDD/AIMDD compliance. The distinction between significant and non-significant changes can be confusing. But the updated MDCG 2020-3 Rev.1 guidance outlines new options: It gives manufacturers examples to determine whether the existing declaration of conformity will continue to be valid in the event of product changes. In the following sections, you'll learn exactly what is meant by significant and non-significant changes and how our experts can help you evaluate your change request.
One of the key elements that defines success in the medical device industry is understanding and complying with the regulatory framework and its many requirements.
Currently, the focus here is on Article 120 of the Medical Device Regulation (MDR), which was updated by Regulation (EU) 2023/607. This article sets out the transitional arrangements for existing MDD/AIMMD medical devices, also known as legacy devices. Manufacturers have the option to continue marketing these devices, for example, until December 31, 2027 or 2028, under certain conditions.
One of those conditions is that during the transition period, no significant changes may be made to the devices that would require a new conformity assessment.
But how can it be determined which changes are considered significant and which are not? And with the current unstable economic situation, how can a product remain marketable over this long period of time?
This is where the updated guideline "MDCG 2020-3 Rev.1" comes into play.
MDCG 2020-3 Rev.1: From minimal adjustments to major changes - What is allowed?
In May 2023, the guideline "MDCG 2020-3 Rev.1" was published as an update to the original "MDCG 2020-3" entitled " Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD ".
According to this updated guidance, significant changes are those that affect the safety, performance or intended use of a device. Examples could include:
- fundamental design changes,
- changes in the sterilization process, or
- Extensions of the intended use.
Such changes usually require a new declaration of conformity.
In contrast, adjustments to operating instructions or replacement of components with identical specifications are not considered significant. Such changes do not require a new conformity assessment as long as they do not affect the safety and performance of the product.
To minimize the complexity of evaluating product changes, the Medical Device Coordination Group (MDCG) has incorporated flowcharts into its guidance. These visual aids are intended to provide manufacturers with a structured approach. However, don't be fooled: Applying these guidelines in practice is often more complicated than it first appears. It is not uncommon for details to make all the difference!
If a change request can be clearly assigned to one of the examples given in the guidance, the next regulatory steps seem clear. However, a clear assignment is often not that easy and requires a precise analysis of the situation. In addition, the evaluation of the extent to which there may be an impact on the safety and performance of the product is also not always trivial.
Successful product or process changes with our expertise at your side!
The fact is: product changes can be complex. But thanks to the updated MDCG 2020-3 Rev.1 guideline and the extended transition periods of the Amendment Regulation (EU) 2023/607, manufacturers are given more options and additional time to ensure that their medical devices can be kept safe and performing in the market in the years to come. Take advantage of this and feel free to contact us if you have any change requests or a need for a change. We scan the regulatory requirements for you, evaluate your change request in terms of MDCG 2020-3 Rev. 1 and accompany you during the implementation.
At TentaConsult Pharma & Med GmbH we are specialized in navigating you safely through these regulatory requirements. Our experts are at your disposal in every phase of the product life cycle! Keep your products marketable with the flexibility you need and in compliance with regulatory requirements.
Contact us to benefit from our expertise.