SBS - The best value in QMS software

"Disappeared" Linkedin Notified Body Rant

Watchcat

Trusted Information Resource
#1
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?
 
Last edited:
Elsmar Forum Sponsor

Watchcat

Trusted Information Resource
#3
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.
 
Last edited:
Thread starter Similar threads Forum Replies Date
sagai I: Level 2+ Content disappeared from FDA.gov US Food and Drug Administration (FDA) 2
Sidney Vianna LinkedIn bug - Anyone has any idea of how to fix this? Posts not showing for me in a Group feed. Coffee Break and Water Cooler Discussions 2
Marc Is something happening with Linkedin "Groups"? July 2018 Coffee Break and Water Cooler Discussions 15
Marc ASQ Linkedin Group - Microsoft Sharepoint discussion - June 2017 Quality Assurance and Compliance Software Tools and Solutions 0
Marc New Malware Targets Facebook and Linkedin Users through Image Files Coffee Break and Water Cooler Discussions 0
Marc Microsoft just bought LinkedIn For $196/Share World News 9
Marc LinkedIn Accused Of Secretly Selling Members Professional Data To Potential Employers World News 9
Marc Searching Linkedin Posts - What am I missing? After Work and Weekend Discussion Topics 14
Marc Hackers Scrape LinkedIn Member Profiles After Work and Weekend Discussion Topics 12
R LinkedIn Customers Allege Company Hacked E-Mail Addresses After Work and Weekend Discussion Topics 0
T Connect on LinkedIn with Company Recruiter Career and Occupation Discussions 7
B Are Premium LinkedIn accounts worth the investment? Coffee Break and Water Cooler Discussions 5
Marc UK Executive Forced Out of Job For Posting Resume On LinkedIn Career and Occupation Discussions 2
Howard Atkins ISO/TS 16949 3rd Party Automotive Auditors Group on LinkedIn ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
M RAPS (Regulatory Affairs Professionals Society) Brazil LinkedIn Network Other Medical Device and Orthopedic Related Topics 0
ScottK What is LinkedIn doing with the "People you may know" box? After Work and Weekend Discussion Topics 8
hogheavenfarm LinkedIn users-Elsmar Cove Group formed Coffee Break and Water Cooler Discussions 37
ScottK Taking wagers on my latest LinkedIn question After Work and Weekend Discussion Topics 1
ScottK Do any of you use "LinkedIn" or any other 'networking' web site? After Work and Weekend Discussion Topics 49
P Notified Body Approval of Change EU Medical Device Regulations 2
K Adding the Notified Body Number CE Marking (Conformité Européene) / CB Scheme 2
A NB (Notified Body) Audit of Standards ISO 13485:2016 - Medical Device Quality Management Systems 3
J Conflict of Interest Registrar/Notified Body/Testing House Quality Manager and Management Related Issues 4
R Plea for advice on transitioning between Notified Bodies (label updates) Medical Device and FDA Regulations and Standards News 1
B Notified Bodies for Software (MDR) EU Medical Device Regulations 1
R Change Notification - Registrar vs Notified body ISO 13485:2016 - Medical Device Quality Management Systems 1
M Notified Body audits -Class Ia medical device product EU Medical Device Regulations 4
Watchcat How Many Notified Bodies are "Enough" Already? EU Medical Device Regulations 23
dgrainger Informational MHRA guidance update on withdrawal of Notified Bodies Medical Device and FDA Regulations and Standards News 0
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
Y When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019? ISO 14971 - Medical Device Risk Management 1
J Mislabeling - Consider this an FDA notified recall? CFR 806.10 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
R Notified Body for MDD 1Q20 - Florida Company Registrars and Notified Bodies 4
M Informational EU – New notified body designated under the MDR – NB 2797 BSI Group The Netherlands B.V. Netherlands Medical Device and FDA Regulations and Standards News 0
M Informational EU – New notified body designated under the MDR – NB 1912 – DARE!! Services B.V. – Netherlands Medical Device and FDA Regulations and Standards News 0
N Customer asking if their notified body can audit us ISO 13485:2016 - Medical Device Quality Management Systems 5
M Informational BSI UK notified under the IVDR Medical Device and FDA Regulations and Standards News 2
N MDR review process by notified body - How many steps exist in the review process EU Medical Device Regulations 0
Ed Panek CAPA against Notified Body? EU Medical Device Regulations 5
M Informational EU – MDCG 2019-6 v2 Questions and answers: Requirements relating to notified bodies Medical Device and FDA Regulations and Standards News 0
M Informational EU – First IVDR designated Notified Body – DEKRA Certification GmbH Medical Device and FDA Regulations and Standards News 0
M Informational EU – October 2019 update – State-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 2
N Regular meetings with Notified Body EU Medical Device Regulations 13
M Informational MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies – August 2019 Medical Device and FDA Regulations and Standards News 0
M Informational EU – New designated Notified Body under the MDR – TÜV Rheinland LGA Products GmbH Medical Device and FDA Regulations and Standards News 0
M Informational New designated Notified Body for Regulation (EU) 2017/745 (MDR) included in Nando – IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A. Medical Device and FDA Regulations and Standards News 3
M Informational EU – Next Notified Body designated to the MDR 2017/475 is IMQ S.p.A from Italy Medical Device and FDA Regulations and Standards News 0
M Informational EU – DEKRA Certification GmbH is the third Notified Body designated under the MDR Medical Device and FDA Regulations and Standards News 0
M Informational EU – State-of-play of joint assessments of Notified Bodies in the medical device sector – June 2019 Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom