"Disappeared" Linkedin Notified Body Rant

Watchcat

Trusted Information Resource
I posted this on LinkedIn, as a reply to this post by a sales rep with "BSI Notified Body" who had just been assigned a new sales territory:

Same job - new territory. See too many negative posts about Notified Body lack of responsiveness - so here’s my challenge to industry- message me below and I’ll get back to you within 24 hours.

My reply was "disappeared" from LinkedIn within a matter of hours. Shocking, I know. But I saved a copy and thought some people here might find a good notified body rant very satisfying about now:

Since I’m in the enviable position of not needing a response from any notified body, I can comfortably rant on behalf of those who do:

What would be the point? I don’t think anyone who is complaining just wants a friendly reply. They want hard information, and they want it now:

o If they have no MDD-designated notified body, they want to know WHEN AND IF one of BSI Group’s two MDD-designated notified bodies will accept them as a client and can it issue them an MDD certificate before May 26? Bwaahahahahaha

o If they have no MDR-designated notified body, they want to know WHEN AND IF one of BSI Group’s two MDR-designated notified bodies will accept them as a client and can it issue them an MDR certificate on or before May 26? Bwaahahahahaha

o If they are an “existing” client of one of BSI Group’s two MDD-designated notified bodies, they want to know WHEN: When can they apply for MDR certification(s), when will they hear back about the application(s) they have already submitted, when will they get audited, when can they expect to have certificate(s) issued??? Bwaahahahahaha

[BTW, When BSI says it is prioritizing its “existing” clients, does it mean the clients it previously served under the MDD? Or does it mean the clients that “exist” for BSI, in the sense of it is not turning a blind eye and a deaf ear to them?]

Perhaps you could post some of the information that people who are complaining would be thrilled to know, e.g., how many “existing” clients does BSI Group’s two MDR-designated notified bodies think they have? How many of those clients have submitted applications? For how many devices? How many of those devices have already received certificates, how many are in active review, how many have audits scheduled, and what are the current timeframes between submission of an application and certificate in hand??? Bwaahahahahaha

PS Congratulations on your new role with...???? There is no "BSI Notified Body" listed on NANDO as a notified body designated under either the MDD or MDR, so a response from you would not be responsiveness on the part of a notified body, I don't think? Is this some internal unit BSI formed for the express purpose of confusing "existing" and potential clients? Or did it serve some internal purpose that superceded client considerations?
 
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Watchcat

Trusted Information Resource
I had a long chat with John Bis, VP Medical Devices Solutions Sales with BSI. I got some information that was certainly of interest to me. I’m not sure how much of it might of value to someone who is a current BSI customer, or without an MDR-designated NB altogether, but with John’s permission, I will share it regardless. (Parenthetical statements below are my own musings.)

Under the MDD, BSI UK did around 500 certificates renewals per year. (If BSI’s certificates expire every 5 years…which I did not confirm with John, that means "existing" clients had around 2500 devices in need of CE certificates under the MDR, plus maybe some up-classifieds.)

BSI stopped accepting applications for new MDD certificates in mid/late 2018, and started accepting applications for MDR certifications in June of last year. They are fully booked with MDR clients until the latter part of this year; date still unknown.

They are trying to do as many early MDD renewals prior to May 26 as possible, a pretty good strategy, I think, to better manage the MDR burden going forward. They have about 2200 to complete by May 26. They are also doing original MDR certifications, presumably for devices that were not a good fit for renewal, for one reason or another. I guess we can estimate 2500-2200 = 300 of those.

(There was some confusion in terminology, as he calls a renewal at expiration a "recertification" and renewals prior to expiration "early renewals." I think they are both renewals, just with different timeframes relevant to the original certification, so I had a little trouble trying to figure out what a "re-cert" was if it wasn't a renewal. There was also something about an ortho 5-year renewal that I didn’t understand and didn’t press him about. Maybe BSI routinely does ortho devices at 5-year intervals and other devices for other timeframes? I have worked with BSI only on ortho devices in recent memory, and those were 5-year certificates)

He said they were open for ISO13485/MDSAP audits now. (My guess is that's because no one wants to commit to a QMS audit until they are sure they know which NB will be issuing their CE certificates, given that in the past NBs have reportedly gotten a bit cranky if a company took its QMS audits somewhere else.)

His advice on non-responsiveness is to keep calling. :D

His most important message is that they will not extend the May 26 deadline. (I don't think that message has been important for a long time now, at least not to medical device companies. I'm also skeptical that he is really in a position to know. I tend to think of corporate sales people like White House press secretaries...what they get told is not necessarily what is actually going on.)

I also suggested a few "creative" solutions for NBs to deal with the logjam. He was quite adamant that the CAs will be all over them, but I just don't believe CAs have anything like the resources for that.

We both agreed that there is nothing to be done now except roll with the process, which will take however long it is going to take, and that, for some medical device companies is not going to and never was going to, end well, and that this is built into the regulation more than in the hands of the NBs. We both hoped that, somewhere out the other side will emerge better quality NBs, device companies, and devices. We did not compare levels of optimism on this hope being realized but…he’s sales, and I’m regulatory, so I think we can all figure that one out.
 
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