The Regulation - Official Journal of the European Union - 2017
Translations - Regulation (EU) 2017/745 of the European Parliament
Translations - Regulation (EU) 2017/745 of the European Parliament
Regulation (EU) 2017/745 of the European Parliament
- Thread starter Marc
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Watchcat
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I think it is useful to remember that "corrigere" means "to correct" not "to change."
Everyone involved seem to agree that the original intention was for 1r devices to have the same deadline as 1s and 1m. Thus, this was simply a correction to the document. The deadline specified for other class I devices was written as originally intended, and therefore there was no correction to be made.
I gather that, if there is not agreement among those in charge of these things that something represents an error in the document (rather than an error in judgment, lol), it cannot be addressed in a corrigendum.
Everyone involved seem to agree that the original intention was for 1r devices to have the same deadline as 1s and 1m. Thus, this was simply a correction to the document. The deadline specified for other class I devices was written as originally intended, and therefore there was no correction to be made.
I gather that, if there is not agreement among those in charge of these things that something represents an error in the document (rather than an error in judgment, lol), it cannot be addressed in a corrigendum.
I'm not so sure that this was the original intent. 1m and 1s devices were already subject to additional scrutiny (compared with plain class I devices), so it makes sense to allow some additional grace period (just like higher classes devices with MDD certificates). Contrarily, 1r devices were not subject to the same additional scrutiny and I think that the original intent was to raise the bar for them. What we see now is not, in my opinion, just a technicality; but rather a disgraceful caving to manufacturers' negligence to anticipate and address the changes introduced by the MDR on time. The cricket played all summer and when winter came he was not ready for it. Apparently, the Union simply has no choice - otherwise there would have been a mini availability crisis (or a compliance crisis).
Why is it disgraceful? Because the Union's tone has all along been "There will be no extensions, there will be no extensions, absolutely no extensions", and now it's like "You know what?... Actually, you can have your extension."
Long live all crickets.
Watchcat
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Surprisingly, what politicians agree on as the story is not always the same as the truth.
That said, I do think that this is the philosophy underlying corrigendum; whether it is always followed is another matter.If this is the only thing they cave on, I will be happy to give them a pass on this one. Moreover, if this is all they gave on, I'm going to be skeptical about whether this was a cave, at least one driven by an availability or a compliance crisis, or the (real or imaginary) threat of such a crisis. There are plenty more such coming, and if the EC doesn't cave because of those, I will be inclined to think they weren't caving on this one, either.
I also think, given the philosophy of the corrigendum, it will be impossible for them to hide behind one if they decide cave on larger matters. "Oops! Does the document say 2020? We just agreed that we meant to say 2022." is a pretty hard sell, lol. I think they will have to cave outright, or not at all.
Can't wait to see how it all plays out!
[...] "a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body" [...]
This includes way more than just the class Is, Im and Ir devices. This includes e.g. all the software devices that were class I under the MDD and are upclassified due to the MDR.
If I was a manufacturer for one of these devices and if I had invested a lot of resources (e.g. for consultants) to comply with the requirements before the date of application, I would at least consider suing the EU.
Do not get me wrong. I think this deadline extension is the right step for two reasons:
1. To have the shortest transition time for the devices with the lowest risk was a weird step in the first place.
2. For most of the upclassified device, especially small companies had a really hard time finding a notified body. They did not need one before and most NBs are working to capacity helping their existing clients. Thus, even if they are MDR compliant in time, they will not get a certificate before the date of application due to the NB bottleneck.
This includes way more than just the class Is, Im and Ir devices. This includes e.g. all the software devices that were class I under the MDD and are upclassified due to the MDR.
If I was a manufacturer for one of these devices and if I had invested a lot of resources (e.g. for consultants) to comply with the requirements before the date of application, I would at least consider suing the EU.
Do not get me wrong. I think this deadline extension is the right step for two reasons:
1. To have the shortest transition time for the devices with the lowest risk was a weird step in the first place.
2. For most of the upclassified device, especially small companies had a really hard time finding a notified body. They did not need one before and most NBs are working to capacity helping their existing clients. Thus, even if they are MDR compliant in time, they will not get a certificate before the date of application due to the NB bottleneck.
Watchcat
Trusted Information Resource
Oh, my. So many potential comments, so little time...
Yes, that's one of the things I like most about it.
What new requirements applicable to these devices require the investment of a lot of resources? Especially for consultants?
LOL, spoken like a true American, especially the "at least consider" part. (If you aren't one under law, you are one in spirit, trust me on that. Takes one to know one.)
In any case, as far as I can tell, the reaction of the manufacturers of these devices to the delay is quite the opposite, probably because few had yet invested much in the way of the resources, and a good number never intended to. For many of them, the delay doesn't represent a savings of resources, but an extension of the time they can continue to sell their products in the EU without regulatory oversight. When they can no longer do that, they plan to pull up stakes and look for other markets. I had already started to see an uptick of interest in 510(k)-exempt devices, along with posts asking "what countries have the lowest regulatory burden?"
Not sure what the EC was thinking here, if it even was. However, if you assume that the level of clinical risk associated with use of a device is inversely correlated with regulatory burden (usually a safe assumption), then you would expect transition time for lower risk devices to be less than for higher risk devices. Since this inverse correlation holds true under the MDR, it probably made sense at the time. The potentially unexpected development was the scarcity of NBs. That the newly designated NBs would prefer big clients (big ka-ching) to small clients (small ka-ching) and clients with high-risk devices (high ka-ching) to those with low-risk devices (low ka-ching), and would prioritize (some) existing clients over new clients, should have been predictable.
If you also assume the level of clinical risk is not a measure of the level of clinical value, and that patient care is going to be negatively affected if a lot medical devices can't get certified by May 2020, the idea could also have been to review the classes that could be certified most quickly first, and get them out there, before settling down to the long haul of reviewing higher risk devices.
Eh. This doesn't distinguish them from the untold number of companies that previously had an MDD-designated NB, but not one that has been designated under the MDR...yet, or ever. Some of them will have a grace period for devices that were MDD-certified, but many waited too long to seek re-certification, and are now being caught short. Oops. And then there are the companies with an MDD-designated NB, one which has been (or will be) MDR-designated, but will decline to take them on as clients under the MDR, because they got to know them only too well as clients under the MDD.
PS What's with the "had"? I would guess many, perhaps most, small companies are still looking, many will still be looking come May 2020, and many others never bothered to look, have stopped looking, or will stop looking by May 2020.
Yes, that's one of the things I like most about it.
What new requirements applicable to these devices require the investment of a lot of resources? Especially for consultants?
LOL, spoken like a true American, especially the "at least consider" part. (If you aren't one under law, you are one in spirit, trust me on that. Takes one to know one.)
In any case, as far as I can tell, the reaction of the manufacturers of these devices to the delay is quite the opposite, probably because few had yet invested much in the way of the resources, and a good number never intended to. For many of them, the delay doesn't represent a savings of resources, but an extension of the time they can continue to sell their products in the EU without regulatory oversight. When they can no longer do that, they plan to pull up stakes and look for other markets. I had already started to see an uptick of interest in 510(k)-exempt devices, along with posts asking "what countries have the lowest regulatory burden?"
Not sure what the EC was thinking here, if it even was. However, if you assume that the level of clinical risk associated with use of a device is inversely correlated with regulatory burden (usually a safe assumption), then you would expect transition time for lower risk devices to be less than for higher risk devices. Since this inverse correlation holds true under the MDR, it probably made sense at the time. The potentially unexpected development was the scarcity of NBs. That the newly designated NBs would prefer big clients (big ka-ching) to small clients (small ka-ching) and clients with high-risk devices (high ka-ching) to those with low-risk devices (low ka-ching), and would prioritize (some) existing clients over new clients, should have been predictable.
If you also assume the level of clinical risk is not a measure of the level of clinical value, and that patient care is going to be negatively affected if a lot medical devices can't get certified by May 2020, the idea could also have been to review the classes that could be certified most quickly first, and get them out there, before settling down to the long haul of reviewing higher risk devices.
Eh. This doesn't distinguish them from the untold number of companies that previously had an MDD-designated NB, but not one that has been designated under the MDR...yet, or ever. Some of them will have a grace period for devices that were MDD-certified, but many waited too long to seek re-certification, and are now being caught short. Oops. And then there are the companies with an MDD-designated NB, one which has been (or will be) MDR-designated, but will decline to take them on as clients under the MDR, because they got to know them only too well as clients under the MDD.
PS What's with the "had"? I would guess many, perhaps most, small companies are still looking, many will still be looking come May 2020, and many others never bothered to look, have stopped looking, or will stop looking by May 2020.
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The mere additional workload compared to the daily business forced some of our customers to acquire some temporary human resources to comply with the requirements in time.
I had to cross an ocean to get to the US, but I get your point. Although, this idea is not mine alone. Originally, a former member of the European Commission told me that he would recommend to sue the commission as a manufacturer, if the manufacturer did everything to comply with the MDR but was unable to find NB capacity. The reason he claimed was that in that case the EU had created "a law impossible to comply with".
That is one valid way to put it. On the other hand, if you assumed that there was a lack of proof of safety and conformity prior to the regulation, you would want to remove this lack for the devices with the highest clinical risk first.
I think, that is quite generous of you. A group of experts had to see this coming and should have thought of a back-up mechanic.
I absolutely agree. All this does is, is pushing some workload (I wish a had numbers on these) to later stages. This is not a fair solution and there are still lots of issues. Some manufacturers just can call themselfs ... I don't know "lucky", I guess?
Especially keeping in mind that the corrigendum is not even place yet, this was the wrong wording. I was referring to the "lucky ones" that now have a longer transition time and therefore also have more time to find a notified body.
Watchcat
Trusted Information Resource
I also think that someone's original intent with the new regulations was to raise the bar, but not just for Class 1r. Whether this intent is still alive, much less a driving force behind anything, I can't say. However, I wouldn't think it is the motivation behind "there will be no extension." I'm all for raising the bar, but these devices have been flying under the radar for decades, so, in the whole great scheme of things, another two years for 1r devices doesn't matter to me, as long as the bar gets raised...not just for 1r devices, but for all of them.
It has certainly been the tone around the internet, but whether this tone was the EC's tone, I can't say. Can you?
I've mostly heard these claims from people who said that the EC said, or from people like Erik Vollebregt, who was commenting on what the EU law allows, not on claims made by the EC. If it was in an online post, I'd look for a link to a source, but would not find one. I would sometimes ask, but get no answer, or the source was someone somehow affiliated with the EC speaking at an industry meeting, not an official statement. And often not a proactive claim, just a response to a question that was only ever going to get one answer. Perhaps even asked to elicit the answer, so that it could be repeated.
Watchcat
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Those aren't consultants, those are temps. You hire temps for one of two reasons:
1) You don't have anyone inhouse with the necessary expertise and skills, and you perceive the need to be temporary in nature.
2) You have people inhouse with the necessary expertise and skills, but they are already maxed out, and you perceive the need to be temporary in nature.
If the resources were invested due to #1, that was just pay me now or pay me later, with no meaningful difference between the two, plus their competition had to do the same thing, so no big deal. In the meantime, they got a two-year reprieve from NB fees, so they should be cheering, not whining.
If the resources were invested due to #2, companies don't tend to overhire human resources, so people inhouse are always maxed out and will always be maxed out. The same rationale applies...pay me now or pay me later, with no meaningful difference between the two. The exceptions were the companies that adopted a strategy of hope and denial, instead of a plan to conform in a timely manner. By the time they blinked, they probably had to pay premium prices to get the work done on an expedited basis. Poor babies.
Manufacturers can be found on a spectrum of urgency with MDR and IVDR implementation, ranging from catatonic denial / merry Titanic orchestra behavior, to angry with the process, to making this a historic opportunity to out-comply competitors. I see management just incapable of looking more than three months ahead and underestimating things monumentally, with Regulatory Cassandras leaving the company or pining away trying to complete an under-resourced MDR or IVDR project. And why would you resource it properly as company – it’s only core business, right? Erik Vollebregt, August 5, 2018
The companies that are being seriously caught out...and there are legions of them....are those whose "self-certification" was never much more than a piece of paper, so they are having to scramble to comply with the MDR in its entirety, almost from scratch. My guess is that most of these companies will finally wash out of the EU market entirely.
This brings up another thing the companies that have already conformed to the new requirements should be cheering about instead of whining about...less competition, bigger market share. This means their investment in resources should yield an attractive return, which is the important thing, not whether that investment was made over the last couple of years instead of the next couple of years.
The other group that is being seriously caught out is all the eager service providers who repeatedly insisted that the EC would not extend, not that they were in a position to know. Serious credibility hit.
Well, welcome to America. I was born here but am hoping to at least die somewhere else. Maybe by crossing an ocean, or maybe just by driving south. One of my fantasies is to make it all the way to Cape Horn...and then just keep on going, like Thelma and Louise.
Some people are always full of bright ideas about things other people should do.
And is this a basis for legal action under some applicable law?
Which is no doubt FDA's thinking, as it tends to prioritize Class III first, Class I last. This makes sense if you accept the notion that Class I devices are really Class I devices. However, when the only assessment of clinical risk has been done by the manufacturer, which is to say, with a glaring conflict of interest...I've never figured out if the regulators are really that naive, or if they just don't want to know.
LOL, not usually my strong suit. I guess that depends on your perspective. Mine is that the EC/CA "experts" who thought May 2020 was adequate time to designate enough NBs might have forgotten to consider that they were the ones who were going to be doing the designating, or perahps they were being generous to themselves in estimating their capacity to do that. Therefore, potentially unexpected by them.
The other possibility is that their estimates were on target. Industry seems to think "enough" NBs means as many NBs as industry wants, but I'm not sure the EC thinks the same.
Whether there is a back-up mechanism, we will only find out if the EC re-thinks May 2020. I personally don't think any re-thinking is necessary, nor that the EC needs a back-up mechanism. I think the NBs are quite capable of "backing up" without any help from the EC. But perhaps here I am actually being generous.
