Notified body change

Hello,

Do you see any other important criteria than the ones below for choosing a new NB?

Type of accreditation (MDR, MDSAP, 13485, else…), Years of accreditation, Expertise, Experience, Scope of Services, Responsiveness, Quality of communication, Quality of service, Quality of support, Certification Cost, Audit Cost, Extra Costs (travel, extra review...), Reputation and References, Auditor language, Geographical location of auditors

Thank you.

Location(s)

We are in the middle of being forced to switch Notified Bodies after receiving our MDR certification and the transfer cost estimates have been ridiculously high. Anybody else have any experience of the costs of transferring a certificate from one NB to another (even if it was just MDD switching)? How can this high transfer cost be justified? No NB's not accept other NB's?

I have no direct experience, however I would say costs are high(er) because under MDR, NBs are not allowed to rely on each other (e.g. issue a certificate based on other NB's review).

It is so maddening. Like sanctioned highway robbery. But what can you do if everyone goes along with it. Makes you want to just get out of Europe altogether sometimes. It would be so easy to just have a transfer fee - I mean they could still pull the certificate at the next review if things were so bad, but then they could go to the Competent Authorities and say look at this other NB and what a bad job they did. Maybe the CA should go audit that NB for cause. What is the point of them auditing the NBs then if NBs cannot be trusted...

QARAM said:

Like sanctioned highway robbery.

Click to expand...

If you requested competitive quotes from a few NB’s and they are all in the same ballpark, not sure what you want. Being a NB brings together some large liability, including the possibility of being sued for hundreds of millions of euros (PIP silicone implants scandal anyone?)

NB’s have been forced to shape up, after several cases of ethical breaches, what included hiring much better qualified and competent professionals. That means much higher salaries what translates into higher prices for manufacturers who cascade such costs to end users and consumers. At the end, if that means blocking unsafe products from the marketplace, the market forces are winning.

Like you said, in the end, it is a business decision if you want to sell your products in the European market or not. But if you are comparing NB fees with Certification Bodies, you are definitely comparing croissants with donuts. Certification Bodies allowed themselves to compete primarily on prices and the service delivery was commoditized what translated in the breakdown of confidence in the certificates issued. Product safety cannot allow the same thing to happen.

Availability of local auditor. In my opinion, the local auditors are usually more lenient rather then oversea auditors which are direct and strict to a T.

Sidney Vianna said:

If you requested competitive quotes from a few NB’s and they are all in the same ballpark, not sure what you want. Being a NB brings together some large liability, including the possibility of being sued for hundreds of millions of euros (PIP silicone implants scandal anyone?)

NB’s have been forced to shape up, after several cases of ethical breaches, what included hiring much better qualified and competent professionals. That means much higher salaries what translates into higher prices for manufacturers who cascade such costs to end users and consumers. At the end, if that means blocking unsafe products from the marketplace, the market forces are winning.

Like you said, in the end, it is a business decision if you want to sell your products in the European market or not. But if you are comparing NB fees with Certification Bodies, you are definitely comparing croissants with donuts. Certification Bodies allowed themselves to compete primarily on prices and the service delivery was commoditized what translated in the breakdown of confidence in the certificates issued. Product safety cannot allow the same thing to happen.

Click to expand...

Not comparing NBs to Certification bodies. And comparing donuts to donuts as long as the donuts want to be eaten. However, one big name NB even said we don't know how to do transfers for MDR so they don't even have donuts. Shows how shaped up they are. And who's to say that some company isn't hoodwinking the NB like the breast implant company - they are just doing a better job. There needs to be for cause auditing, not this nonsense. Yes, making sure the product is safe is good too, but if you trust one NB who was approved for use, why trust the system? It seems very simple, trust the certificate until the next cycle based on the good name of these NBs.

Billy Milly said:

I have no direct experience, however I would say costs are high(er) because under MDR, NBs are not allowed to rely on each other (e.g. issue a certificate based on other NB's review).

Click to expand...

Which section is this talked about in the MDR? Article 58 is not our situation.