MDCG publishes guidance on significant changes for legacy products under the IVDR

The Medical Device Coordination Group (MDCG) has recently issued guidance MDCG 2022-6, Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR.

Article 110(3) of the IVDR lays out the transitional provisions for legacy devices, i.e. IVD medical devices that may continue to be placed on the market under the IVDD beyond May 25, 2022. One of the conditions to make use of the transitional period is that no significant changes to the device’s intended purpose or design must be implemented. In case of a significant change, the device must demonstrate full compliance to the IVDR requirements immediately.

MDCG 2020-6 provides valuable examples and flow charts manufacturers, notified bodies and competent authorities may use to determine if a change is significant or non-significant. 

Among others, the guidance says that the addition of specimen types represents a significant change of the intended purpose.

Among others, the guidance says that the addition of specimen types represents a significant change of the intended purpose. MDCG 2022-6 also mentions that reduced sensitivity or specificity values that have to be included in the IFU due to PMS activities represent a significant change because this adversely affects the device performance. The latter can be especially critical for manufacturers of IVD tests related to the SARS-CoV-2 virus who are still working on compliance with guidance documents like MDCG 2021-21 and thus have to provide additional performance data after May 25, 2022.

As an overall principle, changes must be documented and held available for competent authorities and notified bodies if requested.

We would also like to draw your attention to document management and release procedures in that regard. Essential documents like the declaration of conformity should not be changed after May 25, 2022 unless this is required by the IVDR. If a change is implemented after May 25, 2022, this should be backed by a regulatory rationale in accordance with MDCG 2022-6.

We strongly suggest to carefully ready the guidance document and implement the corresponding procedures. Should you wish to receive the guidance document, please don’t hesitate to get in touch.

Source: MDCG