Significant changes on MDD devices/Old Devices after MDR transitional period

[GiuliaGe]

Good morning everyone!

My name is Giulia and I work as Regulatory Affairs Specialist in a company that produces active medical devices that, like many companies in this period, is carrying on the transition from MDD certification to MDR certification.

In this regard, I would like to start a discussion about the old devices which are defined as: devices placed on the market according to the medical devices Directives before the date of application of the MDR and IVDR.

Old devices differs from legacy devices. Legacy devices in fact are defined as: devices that are placed on the market after MDR or IVDR dates of application respectively and until 26 May 2024 provided that no significant changes are made (Article 120).

For this reason many changes to the products such us software updates will be introduced in the product that will be sold under MDR.

In this regard I wonder what will happen to old devices? for the manufacturer, once the product has been certified according to MDR, will it be possible to introduce the software updates, proposed in the MDR device, also to the same MDD devices already in the field (as old devices)?

In particular, the service life of our device is 8 years. Starting from that point I would like to know: a device sold today as a legacy device could receive in the future, once the MDR certification has obtained, a software update that allows it to provide new diagnostic variables without changing its intended purpose?

Thank you,
any advice and food for thought are welcome

Giulia

 

[Junn1992]

In particular, the service life of our device is 8 years. Starting from that point I would like to know: a device sold today as a legacy device could receive in the future, once the MDR certification has obtained, a software update that allows it to provide new diagnostic variables without changing its intended purpose?

This is where things get kind of tricky. I shall answer the easy question first.

1. New diagnostic variable software patch:
This will definitely be considered a significant change under Article 120 as this is considered a design change. Refer to flowchart in guidance document MDCG 2020-3

2. After May 2024 transition period;
Even if your device shelf life extends beyond this, the CE mark under the MDD will become invalid. So you might run into a situation where you have to do some sort of recall, particularly if the old labels do not have the UDI carrier. This is why everybody is rushing to get MDR audited right now, to avoid a messy transition near 2024.

3. Does a software update "transform" the device from a MDD device to a MDR device?
I would say no, because the GSPR's and conformity assessment procedure requirements differ for the MDD and MDR. But as always, check with notified body on this. The MDD device and documentation could be MDR compliant already. In such a case, I am not sure what NB will say.
For SaMD this is very easy to do, but for an active device incorporating software...really not sure.

HTH.

 

[regularengineer]

This is where things get kind of tricky. I shall answer the easy question first.

1. New diagnostic variable software patch:
This will definitely be considered a significant change under Article 120 as this is considered a design change. Refer to flowchart in guidance document MDCG 2020-3

2. After May 2024 transition period;
Even if your device shelf life extends beyond this, the CE mark under the MDD will become invalid. So you might run into a situation where you have to do some sort of recall, particularly if the old labels do not have the UDI carrier. This is why everybody is rushing to get MDR audited right now, to avoid a messy transition near 2024.

3. Does a software update "transform" the device from a MDD device to a MDR device?
I would say no, because the GSPR's and conformity assessment procedure requirements differ for the MDD and MDR. But as always, check with notified body on this. The MDD device and documentation could be MDR compliant already. In such a case, I am not sure what NB will say.
For SaMD this is very easy to do, but for an active device incorporating software...really not sure.

HTH.

If I could follow up to your example, let's say this is a significant change and the shelf life extends beyond the transition period. I expect this means a new application under MDR will be submitted. Is that correct? And if so, is there information about how long the review and approval process will take?