You may have already heard it from many directions: Eudamed is delayed with two years.
Time to party now because you can shelve your MDR implementation project for two years and go back to do other things? Nope, unfortunately most probably not – read on.
After some pretty mysterious statements of Commission officials in public around the end of October 2019 to the effect that the first tranche of Eudamed might perhaps not be ready to be launched in March 2020 suddenly the text of the Commission information page on Eudamed was changed with the following little block of text:
“The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022.
The date of application of the MDR remains May 2020.”
What does that mean? What follows below is my own analysis from the situation that I could not validate from official sources other than the MDR text itself and the CAMD MDR FAQ. And I have heard a lot of different interpretations and speculation of course.
Eudamed is delayed but the MDR is not
First and foremost it means that only Eudamed is delayed, but not the rest of the MDR. The Commission literally says on the website: the date of application of the MDR remains May 2020. It seems that it would not follow from the fact that you cannot upload documentation that the MDR requires does not mean that you shouldn’t prepare them as of the date of application of the MDR. In the CAMD MDR FAQ the member states say:
“The different Articles listed in Art. 123 para 3 d (= dealing with e.g. the registration of devices and economic operators, clinical investigations, notified bodies, vigilance, post-market surveillance, market surveillance) are not fully postponed with regard to their application but generally remain applicable from the DoA. However, their application is postponed as far as the obligations and requirements within these Articles relate to EUDAMED (which is not fully functional yet). To that extent they shall apply from the date corresponding to 6 months after the date of notice of full functionality.
Meanwhile (until EUDAMED is fully functional) the corresponding provisions of the Directives regarding exchange of information continue to apply.
The principle is that the derogation applies to the electronic exchange of information/upload to EUDAMED. If the derogation is applicable this does not necessarily mean that the information itself does not need to be prepared/exchanged. This exchange of information e.g. reports will have to be done by other means in lieu of exchange via EUDAMED (Directives regime). The underlying idea behind this paragraph was to ensure compliance with the new obligations and requirements via the “old” systems as far as possible.”
(underlining added – “not necessarily not” is a key concept here , because this means that it may also be decided / interpreted differently at a later stage)
and of course
“The actual practical implication of this concept with regard to the different Articles listed in Art. 123 para 3 d MDR needs a closer look and further guidance, which is in progress.”
Yay! CAMD to the rescue – guidance is coming! Oh, hang on … If we look in the rolling guidance plan it says: “Eudamed Group yet to be established under MDCG, ongoing work falls under the scope of the Eudamed implementation Steering Committee”. That’s a hopeful sign of guidance coming soon.
Let this sink in, in case you or your colleagues have let out a sigh of relief, you maybe have done a little departmental celebratory line dance to celebrate that the pressure is off and this whole MDR thing has been moved two years into the future, because it has not been. So, get your colleagues off of the hands that they may have immediately been starting to sit on again, safeguard your budgets that management may have immediately cut: this MDR thing is happening, even if Eudamed is not happening yet. If your management thinks delay means nothing is happening anymore, slam their fingers in a door while yelling “NO DELAY OF MDR!!!” to condition them to the inevitable reality that they keep forgetting. Reporting and registration into Eudamed is delayed, the other things are not and they might need to go elsewhere for the moment.
The MDR even makes provision for the situation that Eudamed might not be ready (see article 123 (3) (d) MDR about the ‘unforeseen circumstances’ that by now were totally foreseen but that’s another story), so it is happening, Eudamed or not. It may not be happening as smoothly as envisaged (I guarantee you that it will not) but the date of application for the MDR does not change. In case anyone in your organisation thinks otherwise: they are wrong and are putting your company at risk.
Why no phased introduction anymore?
It means that the Commission seems to have understood how the MDR works regarding Eudamed, and that it is not possible to say that Eudamed is ready when in fact only the first stage is ready and other stages are to follow, as they were planning when it became clear that Eudamed would not be available fully in time. Perhaps the Commission’s Legal Service has woken up somehow and decided that you cannot declare something that is completely ready when only a slice of it is ready, who knows. Article 34 (2) MDR is pretty clear that Eudamed can only be declared ready based on an independent audit that full functionality has been achieved. Even legal interpretation of rules has its limits.
So what happens now / article 123 (3) (d) and the art of non-Eudamed application
What happens now is that the MDR enters into force exactly as planned (don’t tell me I haven’t been warning you for several years that there would not be a moving of deadlines), but without Eudamed and the MDR provisions regarding the possible situation that Eudamed would not be ready in time (which were always there from the start and which I have been warning companies about for quite some years in the mean time as well) will be applicable – I present to you the staggeringly complex article 123 (3) MDR. These provisions are (unfortunately) not very well written nor easy to distil a very clear set of manufacturer obligations from. In the following I have tried to do some distilling for you. This is my best effort at this moment because a lot of things are unclear. You would almost wish that the Commission would provide timely guidance on the subject (oh… never mind).
I think it’s relatively safe summarize as follows:
- Delay of Eudamed does not mean that the MDR is off the table for the moment (so obvious I’m not explaining this further);
- Delay of Eudamed does not mean that preparation for Eudamed can stop;
- Eudamed will still be implemented at some point because the MDR and IVDR cannot function very well without it;
- You better find a way to track and keep data that should have been going into Eudamed from the start because it is likely that you’ll need to upload it retrospectively when Eudamed goes live and you need to find a way to provide it to the right member state authority (unless we hear differently when the we hear if there are any exceptions to the principle that “this does not necessarily mean that the information itself does not need to be prepared/exchanged”.
So, Confusion Everywhere anyone? Or rather Chaos Everywhere? I’m not sure which one it is these days.
Delay of Eudamed does not mean preparation can stop
The delay of Eudamed does not not mean that preparation can stop for the moment, because reporting and registration into Eudamed is delayed, while all the other things are not. Did I say all things other than registration and reporting into Eudamed are not delayed? That’s because they are not unless we hear differently in specific cases (which we have not for the moment).
This means that the underlying MDR related obligations that lead to reportable and registrable documents still apply.
So you cannot stop work on Eudamed preparation. In fact, you will likely need to step up preparation work. Let me explain why:
The delay results in you having to do multiple things at the same time now:
- first, continue developing the Eudamed interface for your company and getting your device data ready for being uploaded into Eudamed, especially if it’s a machine to machine interface;
- secondly, ensure that device data that is MDR relevant and that is created after the date of application (26 May 2020) is reported under the old regime insofar required (article 123 (3) (d) MDR) but also is put in a Eudamed ready format so it can be uploaded into Eudamed when Eudamed becomes available because you will likely have to do that. It means keeping track of everything that should have gone into Eudamed from the start until Eudamed goes live, so including vigilance data, device iterations, all that (and will be data for two years!!). This will be a big IT challenge. You have to create a spreadsheet or database that approximates expected Eudamed specifications as close as possible so you can upload the data at some point, which will still be a huge job; and
- thirdly, deal with any new national Eudamed like initiatives that member states may maintain or make mandatory pending Eudamed’s delay.
And in addition, you need to do MDR with (AI)MDD tools:
Delay of Eudamed means that existing systems must be kept operational longer
Delay of Eudamed means that you need to report MDR using (AI)MDD systems available at the member states. Sounds like a square peg in a round hole situation? I’m sure it will be like that. Member states may change things around as well as they are preparing too for Eudamed, or maybe lose trust in the project altogether. Quite a few member states have decided that they wanted to run parallel databases of their own and see their decision to do so strengthened by the developments, because patient safety waits for no one. So be prepared to (continue to) work with a variety of non-standardised member state situations, because this was exactly what Eudamed was supposed to fix.
Eudamed for IVDs
So you would think: ah, but for IVDs this is not an issue. Because Eudamed is happening when the IVDR happens. Pfew! Well, maybe think about this in more detail. Article 30 of the IVDR that deals with Eudamed operates on the assumption that Eudamed is already up and running by the time that the IVDR becomes applicable. This means that all Eudamed obligations under the IVDR become applicable simultaneously with (as things are looking now) the date that Eudamed is launched, because the IVDR’s ‘Eudamed is not ready’ regime in article 113 (3) (f) only applies when Eudamed is not fully functional by the date of application of the IVDR. This will also be the date on which the whole rest of the medical devices industry will be uploading their two years worth of data into Eudamed – as things are looking now. This cannot possibly go wrong, right? Scenario anyone?
The sad reality of it
The sad reality of this situation that all of this has the potential to become a total train wreck of unclarity. I have urged companies before to make scenarios for contingent situations. Brexit, Swixit, etc. This is also one of those contingent situations – article 123 (3) was in the MDR since May 2017. Did you not have a “Eudamed is not up yet” scenario? Better start working on it and think about improving your QMS’ ability to deal with regulatory contingencies.
Pending guidance from the Commission nobody has all the final answers, and there are diverging interpretations of what the Eudamed delay will mean. The above is my best interpretation based on the materials I have available and the time I’ve had to dedicate to figure this out. There are different interpretations than mine around, and mine might even be wrong. Of course I will write more about the Eudamed delay on this blog as things develop and hopefully become more clear. The ball for that is very much in the Commission’s court and I hear that guidance is under development.
But doing nothing is always a bad idea under all circumstances. Just ask the hedgehog crossing the road and rolling up when a car comes. So get in gear and stay ahead of this thing as much as you can.