Medical apps under MDR — All-in or caution?

Alternative title: Intention or just bad document control?

Ideally this would just be a short LinkedIn post, stating that MDR gets postponed for a year. Instead things are a bit more complicated. At least for medical apps.

But when reading the proposal (yes, it also still needs to pass Parliament), I was surprised to not see an update to the dates in Article 120 (3). In other parts of Art. 120 and seemingly the whole MDR, May 26 2020 was replaced with May 26 2021. This means that MDR overall will be delayed by one year.

Unfortunately, 120 (3) is important for most medical apps. This is because most medical apps fall in class I under MDD and will be up-classified under MDR. For those devices, 120 (3) defines a transition period of 4 years during which you can continue to offer your MDD class I device as long as you do not do any significant changes.

This article will focus on implications of the proposal on medical apps (especially the category that is known in Germany as DiGA — digital health application).

Are medical device regulatory pathways as unpredictable as gambling?

Just to re-iterate:

• MDR gets postponed, which means that the MDD is still in place until May 25, 2021
• the 120 (3) transition period still starts on May 26, 2020

That means there are the two options for most medical apps:

1. pretend as if MDR wouldn’t exist. Well, until May 26, 2021. Then you’ll be up-classified and you need a notified body certificate right away. No transition period.
2. (semi-)freeze your device by May 26, 2020. Then you have the full 4 years of transition period, as long as you do not do significant changes. But everyone around you will still significantly change their devices.

Option 1 is kind of all-in, while option 2 is the cautious one. It boils down to the question of doing significant changes during the time from May 2020 to May 2021, if you already have a device on the market. If you do not, then this year may definitely be very interesting to you. But what if you do not find a notified body? But maybe the date of the transition period gets changed. Basically punishing those who opted for 2 and benefiting those who were more risky.

Yes, these are two kind of weird options. And it doesn’t seem to be intended.

Coming back to the title and the relation to document control. MDR got updated last December with the 2nd Corrigendum (also known as Christmas present for the medical device industry). Before 120 (3) didn’t have a date included. The 2nd Corrigendum introduced dates to it. Some people believe now that the authors of this proposal were using an older version of the MDR. Well, what does ISO 13485 say about document control? Anyways, fingers crossed, this it’s being corrected. And let’s cross even more fingers that this proposal will be implemented soon.

PS.: I think that most people who are reading this article know what I’m talking about. If there are some assumptions that you feel like need more explanation, please let me know. I’m happy to elaborate on any aspect. Just don’t want the article to explode. That’s also the reason why I try to describe things in normal language as much as possible.

Photo by Markus Spiske on Unsplash