Notified Body
TÜV Nord Capacity
Declining new customers, also declining some existing MDD customers (!)
Last tried 11/2022
These are user-submitted reviews of medical device companies describing their experience working with this notified body. This includes how well-organized the notified body was, technical proficiency of the auditor, wait times and cost.
Important Notes
Notified bodies typically work with many different auditors, some of which are freelancers. That's one of many reasons which may lead to strongly varying reviews of the same notified body.
And lastly: Even though some reviews may be negative, the goal is not to rant about notified bodies. We've built this to facilitate the sharing of information between Healthcare companies. The goal is to improve Healthcare by helping everyone bring medical devices to market in a safe, predictable, affordable and fair way.
As manufacturers get to choose their notified body, these reviews should help companies choose one which is fair, well-organized and technically competent.
November 8th, 2022
Review by small company (<10 employees)
Wait times
QMS Audit: pending
QMS Certificate: pending
Techdoc Audit: pending
Techdoc Certificate: pending
Ratings
Comment on Why You Didn't Choose Them
Though they were our NB for the MDD, they refused us for the MDR.
August 22nd, 2022
Review by mid-size company (10-49 employees)
Wait times
QMS Audit: pending
QMS Certificate: pending
Techdoc Audit: pending
Techdoc Certificate: pending
Ratings
Audit Stage
We are as of today certified to MDD awaiting response for signed offer for MDR (waiting for 2 months already).
Cost
At least 30.000€
Comment on Duration and Cost
Costs have skyrocketed from MDD to MDR
Comment
A TUV-Nord estimate of 2,5 work day effort resulted in 10 months waiting time. And to top it off they had the guts to blame the Covid situation even though we sent in the documents for review 7 months prior the Covid outbreak. They constantly change auditors and TD reviewers. We have been assigned a "main contact" for communications but still receive e-mails form numerous different TUV-Nord employees.
Choosing a notified body is harder than choosing a hair dresser. You can change that.