Newsletter No 34 May 2023

Subject: Update on significant change management for legacy MDD devices

Subject: Update on significant change management for legacy MDD devices

As recently featured in STS Medical Group – The MDR Journey Newsletter[1], the into force of Regulation (EU) 2023/607 amending MDR is now allowing devices which continue to comply with MDD (so-called legacy devices) to be placed on the market until 31 December 2027 or 31 December 2028 under certain conditions. According to Article 120 (3) MDR, these conditions include, among others, that there are no significant changes in the design or intended purpose of the device.

During the legacy period manufacturers may need to make some changes to legacy products triggered by operational improvements or supply chain status to remain competitive in a continuously evolving market. To understand the changes permitted, it is important to have a clear understanding as to what changes in the design or intended purpose would be considered “significant”.

In this regard, there is an update of MDR guidance document MDCG 2020-3[2] just published that provides additional insights and examples of non-significant and significant changes. Below there is a summary of the main concepts and roles.

Changes not concerning the design or intended purpose

These are typically administrative changes concerning the manufacturer’s organization, the manufacturing process or the quality management system.

These changes, even if they need to be reflected in the information to be supplied with the device, should not generally be considered changes in the design or intended purpose.

Changes in the design or intended purpose

1. What do we mean with design and intended purpose?

While the MDD does not define the “design” of a device, the “intended purpose” means “the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials”.

[1] Refer to STS Medical Group ‘The MDR Journey newsletter’ No 32, March 2023, for more information on MDR transitional period extension approved for legacy devices.

[2] MDCG 2020-3 Rev. 1 – 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 – May 2023.

1. How is the significance of changes determined?

The significance is assessed through flowcharts provided in the guidance document MDCG 2020-3. A change is considered non-significant if the answer to every question in the applicable sub-charts from the main chart leads to “non-significant change”. Otherwise, it is considered a “significant change”.

In general, the following changes should be regarded as non-significant:

• Changes related to corrective actions.
• Correction of spelling mistakes or editorial changes of the information to be provided with the device (label or instructions for use).
• Updates of the information to be supplied with the device if they are required by other EU legislation that are mere clarifications and do not adversely affect the devices’ safety and performance in relation to existing or new risks.
• Clarifications of intended purpose, population, clinical application in the information to be supplied with the device in line with the original certification.

Changes to comply with other Union legislation are out of scope even if related to changes in the design, provided that the risk/benefit ratio of the device is not negatively affected.

How are the roles and responsibilities established?

The manufacturer is responsible for providing evidence and justification for every change that does not affect the design or intended purpose, or, in case the change affects design or intended purpose of the device, that it is non-significant.

The changes affecting the design or intended purpose assessed as significant cannot be implemented for devices placed on the market during the legacy period.

The changes should be assessed case-by-case within the manufacturer change management process.

The outcome of the assessment should be documented and made available to a competent authority when requested. The notification process to the Notified Body and Notified Body surveillance, however, will depend on the terms of the certification agreement between the manufacturer and the Notified Body.

The Notified Body is responsible for MDD certificate surveillance including change management and is not allowed to issue new MDD EC certificates under the legacy period but may provide written responses regarding significant change notification.

Additional considerations

According to Article 120(3) MDR, during legacy period devices must continue to comply with the MDD and the requirements of MDR relating to post-market surveillance, market vigilance, registration of economic operators and of devices apply.

How does this affect distributors?

Significant change assessment is managed by manufacturers and reviewed by their Notified Bodies according to the respective agreements for the surveillance process with the aim to continue placing safe devices on the market according to the MDD certification while complying with MDR requirements above.

The role of the distributor is to communicate effectively with the manufacturer to check their MDD/MDR compliance through EC Certificates and transitional period statements, as applicable.

This newsletter is part of our campaign to increase the sensitivity and the awareness of all our business partners, to bring more clarity around the MDR journey and challenges and opportunities around the MDR Art.22 “Systems and Procedure Packs”. 

We are already today all dependent on efficient cooperation. For the MDR implementation, we require even closer collaboration to ensure we all can deliver safe supply to hospitals and patients in the future.

We are confident we will continue to supply health care competently on customized surgical procedure sets and small kits.

Do you wish to know more about specific MDR topics? Do you have any questions or comments about STS newsletter? Write us at MDR2020@stsmedicalgroup.com.

The next MDR newsletter will be issued in June. We wish everyone productive and pleasant days.