How Many Notified Bodies are "Enough" Already?

[Watchcat]

The days to MDR are numbered, and that number grows smaller every day, a pace that is alarming for many in and around the industry. Everyone is asking how many, how many, how many notified bodies will have been designated under the new regulations this month, next month, by the end of April? End of April??? Yikes!

I’d like to consider a different question: How many notified bodies are “enough”? And for whom?

In theory, only one NB is needed...

[Full article attached]

 

[Ed Panek]

I myself have reached out to all of them last week. One of them responded and said no new clients in 2020. The rest have not responded.

 

[Ronen E]

Everyone is asking how many, how many, how many notified bodies will have been designated under the new regulations this month, next month, by the end of April? End of April???

Not really; or at least they shouldn't, because it's not relevant anymore for the question "What's going to happen on May 27, 2020?"

It takes on average 6 months from a successful certification application (manufacturer to NB) to issuance of a certificate, so any designation in 2020 is (on average) irrelevant for certification by May 26. Add to that that a NB doesn't start "pumping" certification on the day it's designated, and you realise that the "(on average)" can practically be dropped from my previous statement.

I have to credit Erik Vollebregt for this observation/analysis.

 

[Watchcat]

I myself have reached out to all of them last week. One of them responded and said no new clients in 2020. The rest have not responded.

Yeah, I think pretty much everyone just has to hang onto their MDD NB and hope it gets MDR certified.

A strategy I might try is to keep a close watch on NANDO, and the minute the next certifications are announced, call those NBs. (I'm assuming you reached out only to the 8 that are already MDR certified and still located in the EU?) The newly designated will probably start by checking to see how many of their "existing" clients are still with them (some companies will withdraw from the EU) and how many of their devices still need to be certified by May 26 (and some companies with withdraw some devices), so there might be a small window of opportunity there.

 

[Watchcat]

I have to credit Erik Vollebregt for this observation/analysis.

Actually, Erik's analysis isn't solid, but then he's a lawyer, not a statistician. My comments are on his blog, but the cliff notes are that MedTech Europe reported that some of its members said that MDD certificates had been taking 3-9 months before the crunch started, sometime in 2017. Erik managed to mangle this into an "average" of 6 months and then added "at least," but of course, if MedTech Europe's data were solid, 3-9 months meant they were taking at least 3 months, not at least 6.

One problem is that there is no universally accepted starting point for EU certification timelines. And no transparency, so it's all just rumor. I recently asked someone at an NB who was responsible for certification management about the MedTech Europe data, and they saw it the same way: "What do manufacturers think when they say "time for conformity assessment"? Is it time from offer approval till receiving the certificate? Or maybe the time from 1st day of the audit till report." And the different NBs have handled the certification process differently, so different companies don't all have the same starting points to choose from.

My own take is that this is totally uncharted territory, and how long things used to take are not likely to be predictive of how long they will take going forward. I am expecting at least some of the NBs to have a few tricks up their sleeves.

 

[Ed Panek]

Actually, Erik's analysis isn't solid, but then he's a lawyer, not a statistician. My comments are on his blog, but the cliff notes are that MedTech Europe reported that some of its members said that MDD certificates had been taking 3-9 months before the crunch started, sometime in 2017. Erik managed to mangle this into an "average" of 6 months and then added "at least," but of course, if MedTech Europe's data were solid, 3-9 months meant they were taking at least 3 months, not at least 6.

One problem is that there is no universally accepted starting point for EU certification timelines. And no transparency, so it's all just rumor. I recently asked someone at an NB who was responsible for certification management about the MedTech Europe data, and they saw it the same way: "What do manufacturers think when they say "time for conformity assessment"? Is it time from offer approval till receiving the certificate? Or maybe the time from 1st day of the audit till report." And the different NBs have handled the certification process differently, so different companies don't all have the same starting points to choose from.

My own take is that this is totally uncharted territory, and how long things used to take are not likely to be predictive of how long they will take going forward. I am expecting at least some of the NBs to have a few tricks up their sleeves.

In addition, with employees shifting companies and high workloads in general, its probable reviewers will be moved around to service higher status customers in time. This could lead to extra delays. As Watchcat mentioned, this is a watershed moment for the industry and the stability (foundation) will take time to settle.

 

[Watchcat]

to service higher status customers in time.

I was initially astonished to hear some of the claims about how long it takes to issue a certificate. Normally, you would expect the NBs to pitch their speed. The head of one MDR-designated NB claimed that it took a year, and emphasized that these are all "original certs." They are original certs on paper, but they are not MDD original certs, for a device, and sometimes a company, that is new to the NB. The NBs are servicing existing clients with existing devices, so they are already familiar with the companies and the devices.

But then I realized that, due to the lack of transparency, this positions the NBs to leave some customers waiting, without those customers realizing/complaining that higher status customers got their certs issued in a good bit less time than a year. Or maybe even 3 months.

I'm about to let the MDR go and concentrate on some FDA stuff, which is where my Watchcat interests lie, but, depending on my time, I might post something quasi-tongue-in-cheek in mid-May, maybe on the order of "Top ten ways to get your MDR certificate in 24 hours or less" or "We don't need no stinkin' certificates!"

 

[shimonv]

A colleague of mine is a BSI auditor. He informed me that they are not accepting new clients this year. He also wrote that it's the same with other NBs except that they don't say it.

It's going to be a difficult year for CE hopefulls.

Shimon

 

[Watchcat]

They may not say it, but the word has gotten around, plus it's fairly straightforward math. BSI UK's first post after it received its designation (and still planned on using it) said it was prioritizing existing clients. This makes so much business sense, you would expect the other NBs to do the same. And you don't need a lot of transparency to guesstimate how long that is likely to take.

 

[Sidney Vianna]

Fascinating and opportunity-rich for a thesis in Business (Mis)Management. The apparent massive asymmetrical positioning of supply and demand in the NB sector should make some people in the conformity assessment world think. But that is a challenge for many of them.

Isn't this a result of years of mismanagement in the sector? Commoditization of conformity assessment services led to buyers price shopping of NB's, what led to substandard assessments, forcing the Authorities to significantly tighten the control over NB's and, along the way, reduce the number of providers. The commoditization approach also meant that NB's cannot attract and retain the talented professionals they need in order to deliver the services in a timely manner.

Pressed by the Regulators on one side and the Market needs on the other, NB's, mostly risk-averse, are missing a huge business opportunity and the Market they serve, left in a conundrum.

Fascinating.