Notified Bodies - Notifying Customers when Changing Registrars?

A

Aaron Lupo

#1
Ok, I need some help! We recently switched Registrars, we were using a Notified Body as we used to CE Mark a product we made. Long story short the part of the company that did that split off and went their own way, so we went with a Registrar that does not do CE marking because we don’t need that service anymore (plus we are saving 13K a year!!).

Here is where the saga starts, one of our customers was mad because we didn’t notify them that we switched registrars, as far as I know there is no requirement for us to do so and the supplier agreement we signed with them does not state we need to. Anyway, they found out we switched to a Registrar that is no a Notified Body and said they can no longer use us for our services because according to their Notified Body we have to use a notified body also. I say no, we are not CE marking the product so they need the notified body not us! There is no requirement in the MDD that we as the supplier need to be ISO, however, their notified body is tell them that; “All the notified bodies got together and decided that in order for a company to CE mark a product their critical suppliers need to also be audited by a notified body”. I say that is a bunch of [email protected], and if that is the case where is that documented.

Has anyone else heard of this or know anything about this.
 
Elsmar Forum Sponsor
R

Rick St

#2
This is quite an issue at this time. My registrar has an "agreement" with a notified body, but one of my customers wouldn't accept the certificate without the notified body's "mark" on it.

There appears to be some pressure being applied by one really large registrar to require the notified body's mark on the certificate. This, I have been told, is because the registrar applying the pressure has lost so much business to smaller, more value-added registrars that they are hoping to use this pressure to "win" new customers (become the registrar of the suppliers to their customer).
 
#3
I'm lost

because according to their Notified Body we have to use a notified body also.
There appears to be some pressure being applied by one really large registrar to require the notified body's mark on the certificate.
Help me out here. Where does a registrar fit in all this? :confused:

I can understand if your customer will not accept your registrar, that happens time and again. But I can't see how your customer's registrar has ANY say in the matter. Can my registrar pull my certificate if they don't like my supplier's registrar? Its not up to them!!!!!!!!!!!!! Or is it? :confused:
 
A

Aaron Lupo

#4
Re: I'm lost

db said:

Help me out here. Where does a registrar fit in all this? :confused:

I can understand if your customer will not accept your registrar, that happens time and again. But I can't see how your customer's registrar has ANY say in the matter. Can my registrar pull my certificate if they don't like my supplier's registrar? Its not up to them!!!!!!!!!!!!! Or is it? :confused:
When it comes to this Particular German Notified Body/Registrar, what has happened is they are imposing a rule on thier customer that does not exsist yet but in their opinion some day will. So what this German Notified Body is saying is that we as the critical service provider need to be audited by a notified body in order for our Cert to be acceptable.

In truth what it really boils down to is this German Notified Body is sour grapes because the company I work for as well as quite a few others have given them the pipe because thier prices are 50-75% higher than most other registrars as well as thier customers service STINKS!
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#5
Honestly, I haven't heard anything stating that any notification must be given to a customer with regard change of service. Unless it is a contractual stipulation, I believe you do not have an obligation to disclose this.

As for my gut feel, what is being said here has been what I have felt in the past, both in the automotive sector as well as the medical device world. For me, I would like to hear from our oversees counterparts and thier perceptions/realities along these lines. A couple of years plus back, when the European Community drew a line in the sand in regards the sale of products that are required to wear the CE marking, I got the impression that they were really after global harmonization. The literature I read regarding CE marking gave me the feel that they wanted everyone to be following the guidelines, although I never saw anything stipulated as this being the case. The difference being that the automotive world makes a clear (er) distinction.

Well, I don't know if that helped any, but I'd like to see where this thread leads us.

Kev
 
A

Aaron Lupo

#6
Kevin-

The funny thing here is that the only Notified Body that requires this of their clients is the Large German one (I would presume you know who i am speaking of). As I said before IMO what it boils down to is they are pissed that people are leaving them in droves and they figure they would get business back this way.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#7
ISO,

I know the group you speak of. I have been using them for many years now for several reasons. Luckily for me, price has not been a point of order, so I haven't had to cross the bridge you had to...yet.;)

Regards,

Kevin
 
B

Bill Ryan - 2007

#8
I don't know if this has much bearing on the discussion but I'll post it anyway. (Taken from Quality Digest - this month)

Notified Bodies

The Notified Bodies are critical elements to successful implementation of the MDD. To ensure their systems are effective requires consistent action by both the Notified Bodies themselves and competent authorities. Today there are more than 60 Notified Bodies designated under the MDD. Questions exist regarding the competency, coherency in interpretation and transparency of their work and decisions.

Competent authorities and manufacturers have questioned the ability of Notified Bodies to conduct conformity assessments in all the designated product areas. Incompetence is unsatisfactory not only from a regulatory perspective, but also because it undermines the value of a robust conformity assessment that might identify problems before they occur. The report states that competent authorities should more carefully designate and monitor Notified Bodies and allow them to specialize in the areas for which they're designated. This would make them more effective.

Also important is ensuring coherent interpretation among Notified Bodies. Many recognize that the Notified Body-initiated NB-MED Group has achieved much progress. The group drafts and publishes Notified Body recommendations and consensus statements, which provide a basis for consensus interpretation and agreement about the MDD requirements. All Notified Bodies are entitled to participate in the NB-MED Group, and most do. However, some critics maintain that the NB-MED Group documents aren't readily available and that not all Notified Bodies follow the recommendations. (A complete set of recommendations is available at www.bsiamericas.com/MedicalDevices/GuidanceDocs/NBRecommendations.xalter .)

The transparency of Notified Bodies' certification decisions is another area of concern. The report suggests that they be required to make more information available about their decisions. The Notified Body Operations Group, created in 2000, addresses and considers all concerns regarding Notified Bodies. This group includes representatives from member states and the European Commission.


Bill
 

YellowQCPro

Starting to get Involved
#9
I would like to have anyone give me some advice on something... our supplier did not notify us of thier change in notified body. Now, we a customer that is not able to sell because the D of C says one notified body, the CE mark is another. I am able to draft a letter for the supplier to sign, but i don't know what to say. Can anyone help? Am i posting in the right thread?
Help!
 
B

Burgmeister

#10
I would like to have anyone give me some advice on something... our supplier did not notify us of thier change in notified body. Now, we a customer that is not able to sell because the D of C says one notified body, the CE mark is another. I am able to draft a letter for the supplier to sign, but i don't know what to say. Can anyone help? Am i posting in the right thread?
Help!
I'm a little confused here Yellow, are you acting as a distributor to your supplier or are they supplying a component for your device?

If you are a distributor then your supplier should provide you with a new DofC with the new NB on. The new NB should have approved the DofC for the product(s) so I would be amazed if your supplier didn't have one with the new details on.

If they are a supplier of a component then the DofC shouldn't really be an issue because it is your DofC that is required to sell your devices not theirs.
 
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
Q Notified Bodies Backed Up? EU Medical Device Regulations 19
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
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
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

Similar threads

Top Bottom