Notified Bodies Backed Up?

QM Becky

Involved In Discussions
#1
Hi Folks,

I've got a NB that appears to be under the MHRA's microscope and reportedly, most if not all NBs are having some challenges with the new regulations and requirements being placed upon them. (I've not confirmed that, just "heard" about it). It appears that my NB is REALLY struggling, so much so that I've now been told that they are accepting ZERO new products for technical file review and addition to my EC Certificate. This presents a HUGE problem for me as I have 2 products waiting now, and a pipeline in the next few months of 3-5 new products to get their CE marks (added to our certificate).

I'm considering transferring NBs - I really don't want to, but I can't take this kind of delay and they don't seem to have an alternative route for me.

We JUST completed our recertification audit in May for our ISO, CMDCAS and MDD certificates, so I suspect a transfer would be fairly straightforward, but I also don't want to sit through another audit, given I just completed the "big"one. Yuck. This whole situation just stinks.

Is anyone else experiencing this? Have you been able to work through it in any way that you could share?

Thanks!:bonk:
 
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#2
Responding just to say we are in the same situation, but haven't decided what to do yet. :(

The sad thing is that we've maintained our ISO through our current registrar for some time now, and have a good working relationship.

It now appears that, in order to deal with the NB backlog, our main option is to abandon this registrar and transfer to another... :nope:

I hope I'm misreading the situations, and there are other alternatives...but so far, I haven't figured out how best to proceed....
 

QM Becky

Involved In Discussions
#3
Mark,
Same here... I really like our registrar and hate the idea of transferring but no product additions? 9-12 month backlog for what's already in que? I just can't make that work. :nope:
 

yodon

Staff member
Super Moderator
#4
I have a client that just went through their initial certification audit with the NB and were then told the backlog for the Technical File review is backed up over 6 months. They apparently discussed the option to have a different NB do the Technical File review and authorize CE marking. I was rather surprised to hear this as an option but maybe it's possible (and a possible path?).
 

Remus

Involved In Discussions
#5
European Commision have introduced new regulations to Notified Bodies, and give lots of major and minor nonconformities. Indeed most of Notified Bodies certificate products with weak technical files, so now they are trying to fix them to save them self. Moreover most notified body don't have enough good technical specialist, and they can't find new people. (Because of old weak directive, most of Medical Device companies ommit QA and Regulatory departments)

Moreover, some people says with new regulation European Commision will decrease notified body numbers around 30 (now around 60).

So, most probably cost and time of certification will increase.
 

pkost

Trusted Information Resource
#6
Continuing to add to this, it's my understanding that most NB's are backed up. Lead times are massive or they are just outright refusing to accept new customers/products.

As already noted, it is due to the increased oversight from the competent authorities. Essentially they are all under resourced and there is insufficient competence in the system to immediately switch extra capability. I'm regularly contacted by recruiters asking if I would be interested in working for one or another NB.

Ultimately, until they can recruit, train and retain the necessary reviewers it is going to stay like this. If not worse with the increased demands as a result of the upcoming regulation
 

Mark Meer

Trusted Information Resource
#7
...Because of old weak directive...
Curious: Other than the PIP Breast Implant scandal (a clear case of fraud, perpetrated by a single company), can anyone provide a strong case that the previous framework was ineffective ("weak")?

I'd really like to see evidence of negative overall outcomes, when compared to a stricter framework (say the US FDA). For example, say, the number of medical-device related deaths in the US versus EU.

Does anybody know if there's any data collected on the number of adverse incidents, comparing incidents (per capita) in the US versus incidents in the EU (pre ammendments)?
 
Last edited:

pkost

Trusted Information Resource
#8
Since when have a few inconvenient details been allowed to get in the way of some good old political posturing?

The other scandal besides PIP was metal on metal hip implants
 

Mark Meer

Trusted Information Resource
#9
The other scandal besides PIP was metal on metal hip implants
Can you kindly link to where I can read more? Was this a specific company, or the entire hip-implant industry? Were they fraudulently dodging regulations, or were they just poorly designing their products?

If these incidents were a big deal, couldn't they have just tightened up on these particular items (through, for example, additional particular requirements), rather than overhaul the entire system for everyone?!

(Sigh) ...just frustrated... :(
 
Thread starter Similar threads Forum Replies Date
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
Watchcat How Many Notified Bodies are "Enough" Already? EU Medical Device Regulations 18
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
Y When will Notified Bodies require MedDev manufacturers to fully implement ISO 14971:2019? ISO 14971 - Medical Device Risk Management 1
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 – 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
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 – 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
atitheya Notified bodies operating in India for medical devices made in India CE Marking (Conformité Européene) / CB Scheme 1
M Informational EU – MDCG 2019-6 Questions and answers: Requirements relating to notified bodies Medical Device and FDA Regulations and Standards News 0
M Informational EU – Update on state-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 1
M Informational Team-NB published a press release regarding the capacities of notified bodies to meet the sector needs Medical Device and FDA Regulations and Standards News 0
M Medical Device News State-of-play of joint assessments of Notified Bodies in the medical device sector EU Medical Device Regulations 0
R Medical devices certified by different notified bodies EU Medical Device Regulations 6
ScottK How's the unannounced inspection by notified bodies going? EU Medical Device Regulations 3
S When will notified bodies be ready to perform audit to the MDR? EU Medical Device Regulations 1
Ronen E Independence on Notified Bodies, inter alia of Manufacturers they Assess EU Medical Device Regulations 7
J What's the big picture on Notified Bodies? EU Medical Device Regulations 4
K 510 (k) - Requirement to notify the FDA or is only the Notified Bodies required? Registrars and Notified Bodies 1
J0anne Effects of Strengthened Surveillance of Notified Bodies in 2015 EU Medical Device Regulations 1
A Using 2 different Notified Bodies CE Marking (Conformité Européene) / CB Scheme 6
Sam Lazzara Experiences with Notified Bodies addressing EN ISO 14971:2012 Annex Zs ISO 14971 - Medical Device Risk Management 5
rob73 If NB's (notified bodies) cannot be trusted how can we? EU Medical Device Regulations 39
Ronen E MHRA Publishes Guidance for Notified Bodies on Regulation of IVDs for Self Testing EU Medical Device Regulations 0
D Recommendations for Own Brand Labeling Notified Bodies for Medical Devices EU Medical Device Regulations 6
Gert Sorensen New EU approach to notified bodies Other ISO and International Standards and European Regulations 0
A Mutual Recognition by Notified Bodies EU Medical Device Regulations 3
A Notified Bodies - Notifying Customers when Changing Registrars? EU Medical Device Regulations 9
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 Change Notification - Registrar vs Notified body ISO 13485:2016 - Medical Device Quality Management Systems 1
Watchcat "Disappeared" Linkedin Notified Body Rant EU Medical Device Regulations 2
M Notified Body audits -Class Ia medical device product EU Medical Device Regulations 4
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
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 – First IVDR designated Notified Body – DEKRA Certification GmbH Medical Device and FDA Regulations and Standards News 0
N Regular meetings with Notified Body EU Medical Device Regulations 13
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

Similar threads

Top Bottom