A new blog post, a new step in the soap that is the non-transitional period of the MDR and the IVDR.
I have jokingly paraphrased the absurdist painter Magritte by saying “céci n’est pas une période de transition”. I’m contemplating starting a T-shirts business with memes for the MDR and IVDR, with that meme and others, like “Regulatory Cassandra” and “I worked myself into the ground to meet the MDR DoA and all I got was this one year delay which is not a delay actually”. And of course for the IVDR I’m still negotiating with the History Channel Ancient Aliens guy to use his portrait on the “Alien invasion scenario, anyone?” T-shirt for my IVD industry readers.
Not a soap, a telenovela
So what is the new episode in the soap you ask? I bet you have some idea from the spoiler in the title of this blog.
At this point I would not even call the MDR and IVDR transitional period a soap anymore, but rather a full blown telenovela. For those that think they know me: did you know I have South American roots (but contrary to popular belief am not a 65 year old Olympic sailor and Sjoerd’s twin brother)? Watching telenovelas with my thirteen year old daughter is one of my guiltiest pleasures. My predicament at the moment is that Netflix still has not released the last season of Jane the Virgin in the Netherlands. Not cool, Netflix – it’s been available elsewhere for a long time already.
Telenovelas are characterised by convoluted subplots involving three or four different settings and involve set archetypical scenarios with surprising plot twist using classic style figures, but overall narrate a set story arc. Contrary to soap operas, which normally have an open end and can last theoretically forever, a telenovela is planned for a specific period unless extended by unforeseen circumstances (such as pandemics, alien invasions or unexpected success).
Sound a lot like the MDR and IVDR transition, right? Let’s zoom in on the subplot of standardisation, since I already gave that much away in the title.
The standardisation sub-plot in the MDR / IVDR telenovela
As I mentioned in my last blog, the standardization bodies CEN / Cenelec would decide on the standardisation request for the MDR and IVDR by 17 June. I also mentioned that not everyone was happy with the request as it went in. It contained references to standards that would be outdated by completion (or even already were at the date of the request), the request was not complete, the request was (way too) late, etc. Those that did not openly critise the request were probably thinking an imperfect and late request was better than no request.
So 17 June came and went last week and we heard nothing. At least, not publicly. However, I was able to confirm from various sources by the end of last week that the request had in fact been rejected by CEN / Cenelec on 16 June (this was confirmed by the Commission in the MDCG subgroup on standards on 19 June and posted by a Commission official on LinkedIn) – they are not going to embark on this project and, procedurally, a new (amended) request will be necessary. This leaves the standardization project under the MDR and the IVDR without legal basis for the moment.
The background of these things is always kind of political but it seems that the main reason for rejection of the request can be found in the persisting tension between the Commission and the standardization bodies about the outcome of the standardization process: the Commission wants standards that are as close to what it sees as European requirements, and the standardization process delivers standards that are state of art according to the experts involved in the standardization process. As a result of EU court case law case the Commission has been on a mission of greater influence over the interaction between standards and regulations. So, my dear readers, as you will understand: this tension is only to be expected because relationship drama is a necessary ingredient of any telenovela.
We did learn that another iteration of harmonised standards under the directives is under preparation, likely to arrive end of this year. You can already put that on your planning. What? You disbanded your whole MDR transition team already and have no resources for this? Not so smart after all.
Like in a telenovela, this is obviously a plot twist. As a company with some sense you had already planned (or finalized) your technical documentation without relying on a presumption of conformity against MDR harmonised standards, because this was a likely outcome of the scenarios that you had been planning for (if haven’t read the ISO 31000 standard, it’s still not too late). This is not your first telenovela, right?
If you’re in IVDs, maybe not count on harmonised standards being available in time – that’s a likely scenario. Why not you say? May 2022 is still far away? As you will have read in my last blog on this subject for the IVDR, it totally is not. And I guarantee you that we will not have harmonized standards under the IVDR before you need them this summer and autumn.
This means that under all circumstances anyone having to file a conformity assessment application under the IVDR or MDR soonish will not have harmonized standards to rely on, and can therefore not rely on a presumption of conformity under the MDR and IVDR.
Back to state of art – for the moment
Dios mio! No presumption of conformity! Why do we even have standards then?
This development does not mean that you cannot rely on international standards at all. Actually, not relying on them at all will make things much more complicated because you lose a common frame of reference with your notified body.
What you will need to do is go back to basics for your GSPRs, as GSPR 1 both for the MDR and IVDR sets out: you will be ‘taking into account the generally acknowledged state of the art’. This means that for each of the standards you reference you will have to draft rationale that the requirement referred to in that standard is state of art for the GSPR that you reference it for. While you may think that the latest standard adopted necessarily reflects state of art, I recommend not to presume this. Check this approach with your notified body before you deploy it across the board. Notified bodies may have had other marching orders from their competent authorities, because those latter ones look at what they think are requirements, and may not necessarily agree that the latest adopted standard reflects those correctly.
Notified bodies position?
It would be fantastic if notified bodies could be explicit publicly about whether they endorse the approach of ‘latest standard adopted = always state of art’ across the board, because that would make life a lot easier. It would be a kind of de facto presumption of conformity that companies can operate on until the harmonization request does yield harmonised standards.
Good news: it seems that there are ongoing efforts in that direction. Bad news: if that happens you may need to revisit your technical documentation for the Z annex gaps defined in the harmonized standards if and when these are finally adopted. I would recommend to keep thinking about what a Z annex might look like for a given standard, and how its adoption would affect the technical documentation.
Common specifications anyone?
We are in the telenovela space, so plot twists are always a possibility (as I tend to say: scenario anyone?). In the presentation to the MDCG standards subgroup the Commission seems to be hinting (or maybe making a veiled threat, depending on how you see it) at development of Common Specifications (CS) under the MDR.
I must say that this is one of the options that came to mind for me as well when I heard the first rumors that the request had been rejected. However, if we look at the Commission’s less than stellar track record on adopting the only two CS that we actually must have under the MDR (one for reprocessing of single use devices and one for the non-medical Annex XVI devices) then the Commission and its chaotic family member the MDCG do not really seem capable of drafting and adopting the scope of the standards in the request plus the work that the HAS consultants would still need to do to draft the Z annexes to define the gaps between the standards and the requirements in the short term. I would chalk this option up to theoretically possible, but not likely.
More likely would be adoption of several targeted CS for some of the requirements under the MDR and IVDR where the EU is not happy with the available standards as being ‘insufficient’, which is exactly what the CS were intended for in the first place. So I would not dismiss the CS option altogether.
As is the rule with telenovelas however, you don’t find out the truth until the last five minutes of the series’ finale. COCIR predicted a decline in harmonised standards for medical devices, so it would not be surprising if this gap would be bridged with CS.
¿Qué es lo siguiente?
What will be next in this riveting rollercoaster? So many sub plot options! The relationship drama between the standardization bodies and the Commission might take an unexpected turn with CS replacing standards, although this is not so likely I think. There may be lots of drama though as they sort things out. After all, this is a telenovela.
The Commission will go back to the drawing board and will work on a new request now, and will have to discuss with CEN / Cenelec how to arrive at a new request that can work for all involved. Since the drama between the standardization bodies and the Commission is in Annex III of the request, which describes the general and specific requirements for the harmonised standards, this is where the magic will need to happen:
I expect that this magic will include, specifically, some developments in the “information on the relevant applicable requirements or parts of the relevant applicable requirements that are not covered by it” (Annex III, part A sub 2) – the Z annex gaps – and in the way that the Commission thinks standardization for devices is supposed to function under the MDR and IVDR. Since telenovelas normally revolve around a family secret, we will also have to live with the thought that we will likely not get to the bottom of this completely as the family secrets are unfortunately never transparent.
The Commission may have to be a bit more like Rogelio in Jane the Virgin when he learned that Xo was pregnant with his arch nemesis’ baby: supportive of whatever choice she would make about it because it was her choice to make and not his. If you’re in it together because you are a public-private partnership, be part of the solution to make it work – a presumption of conformity, after all, does not define the legal standard as such. But, as Rogelio said himself: “If you knew anything about telenovelas, you’d know that everything is supposed to be dramatic!”
Well, it’s like the old novel all over again: global (standardisation) versus local (regulation)…regulators may need to let go “in lieu” of globalisation, but it is just too darn difficult…What novel comes to mind…North and South? How the west was won?
Anyway; thanks for the nice storyline…curious how this story is going to pan out for the IVDR
Hi Alex, it reminds me of Alice in Wonderland actually – wanting your cake (internatinal harmonisation) and eat it (but only if it delivers exactly the standards we want). And the IVDR … still thinking about what novel/movie/play/plot that is.
I can provide a bit of hopeful news on the “fantastic” 🙂 possibility of notified bodies adopting the ‘latest standard adopted = always state of art’ approach. Because the AIMDD harmonized standard OJ list was so stale, our medical device startup established a documented process of systematically adopting the latest revision of international and national standards by documenting a gap analysis on a controlled form. The gap analysis identifies the changes in the revised standard and shows that the level of safety provided by the revised standard is equal to or greater than that of the superseded standard. Our procedure notifies appropriate product development folks when a standard is revised and a gap analysis is produced, so development is always aware of the changes and is always using the latest standard. We have made several successful AIMDD submissions and passed one surveillance audit with our notified body, and auditors and reviewers have accepted our process and our documented Essential Requirements with the latest (and often unharmonized) standards as the generally acknowledged state of the art.