Significant change assessment

Important information about significant change in the line with the MDCG 2020-3 guidance and transitional provision under article 120 of the MDR 2017/745. This guidance helps to understand which changes can be implement within the transitional period of MDR.

Definition of significant change

The definition significant change in the design or intended purpose means and consist of two cumulative elements:

  • there is a change in the design or intended purpose, and
  • the change is significant.

This term is not defined in the MDR, so manufacturers must rely on the definition in MDCG 2020-3 rev.1.

All changes not having an impact on the design or the intended purpose of the device are out of scope of MDR. Equally, changes that concern the design or intended purpose only fall under MDR if they are considered ‘significant’. Changes in order to comply with other Union legislation are also out of scope even if they relate to changes in the design, only if the risk/benefit ratio of the device is not negatively affected.

Significant change and transitional provisions of MDR

Among the main requirements for transitional periods of MDR implementation, no significant changes in design and intended purpose should be implemented and not presenting an unacceptable risk to the health or safety of patients, users or other persons.

In accordance with Article 120 of MDR, devices for which a certificate of conformity with Directive 93/42/EEC (MDD) or 90/385/EEC (AIMDD) has been issued may be placed on the market or put into service until 31 December 2027 or 31 December 2028 (depending on the risk class of the device). However, in order to take advantage of the aforementioned transitional periods  it is very important for both legacy device manufacturers, Notified Bodies and competent authorities to understand what change in design or intended purpose should be considered a significant change.

Who should determine if a change in a medical device is significant?

The manufacturer is responsible for determine the change and analyzing, justifying and providing evidence that the proposed change does not affect the design or intended purpose of the device, or where the change affects the design or intended purpose, that it is non-significant. The result of such assessment shall be properly documented and then made available to the Notified Body. For medical devices other than class I, the changes and their implementation will be verified by the Notified Body at audits or upon change notification submissions, where applicable.

Role of the Notified Body in the significant change assessment

Changes in medical devices and their implementation are to be verified by the Notified Body as part of the surveillance activities, or following a manufacturer’s submission for prior approval of changes.
If a proposed change is not a significant change in design or intended purpose under Article 120 MDR, the implementation of such a change is therefore allowed during the transitional period but no new MDD/AIMDD certificates can be issued. However, the Notified Body that issued the MDD/AIMDD certificate, after evaluating the (proposed) change, can provide a written confirmation that the implementation of the change does not constitute a significant change in the design or intended purpose under Article of MDR, and that the related MDD/AIMDD certificate remains valid until the end of the transitional period.

What actions should be taken in the significant change process?

Manufacturers of legacy devices should integrate the MDCG significant change process guidelines into their QMS. In most cases, this will require an appropriate update of the change management procedure, but it may also involve updating other documents, such as the software lifecycle procedure or the procedure for notifying the Notified Body of changes related to medical devices. Although compliance with MDCG guidelines is not mandatory, the Notified Body and its personnel shall carry out the conformity assessment activities take into consideration available guidance and best practice documents, even if the manufacturer does not claim to be in compliance.
In addition, it should be noted that the examples of non-significant changes listed in the MDCG 2020-3 rev.1 guidelines can only be considered non-significant if the changes do not have a negative impact on the risk/benefit ratio of the device, so each change should be evaluated individually.