Choosing a notified body is hard because you can't find any reviews by past customers.
Let's change that! We're collecting anonymous reviews by other companies here and publishing them openly, for free.
That enables you to choose a notified body which actually understands software and replies to emails (yes, the bar is that low).
New: Notified Body Capacities (a.k.a. the MDR fiasco)
As an increasing number of Notified Bodies have started to decline accepting new customers, we've added indicators below to reflect their capacity.
Green means they're scheduling audits in a reasonable time frame, yellow shows an unreasonable time frame (many months), red means they don't accept new customers and dark red means they don't even respond to emails.
We don't have capacity data on all Notified Bodies. So please message us if you know more! :)
Of 35 Notified Bodies in total,
0 (0%) offer audits in less than 6 months,
6 (17%) offer audits with a wait time of 6-12 months,
11 (31%) don't accept any new customers and
7 (20%) don't reply to emails.
And for the remaining 11 (31%) we don't have any data - yet.
Send us an email if you know more!
Important Notes on Reviews
While we've gathered quite a lot of reviews spanning multiple notified bodies, we don't have a whole lot of reviews for each notified body. That's why we decided not to calculate an average rating for each notified body - for now.
Also, 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.
DNV Product Assurance
Accepting new customers, audit dates unknown
Last tried 10/2022
Declining new customers for 2023, waitlist for audits in 2024
Last tried 10/2022
Polskie Centrum Bacan I Certyfikacji
Not replying to emails
Last tried 10/2022
Declining new customers, also declining some existing MDD customers (!)
Last tried 11/2022
56 reviews in total
What does "capacity" mean?
Generalizing this a bit, the indicators should help new startups choose a notified body, that's why "capacity" refers to "capacity for new customers". In our opinion that’s also the most important aspect because, with the MDR transition, many companies will truly be new customers. Specifically, we display the capacity for auditing standalone software medical devices; capacity for other devices (hardware, implants, etc.) might be different but we don't bother about that, because most of our website visitors (and all of our customers) develop software.
What do these colors mean?
Dark red means the notified body didn’t respond to an email inquiry within a reasonable time frame (one week or so), red means they declined taking on the (new) customer, yellow means an audit date was offered within many months and green means a sooner audit date.
Where does this data come from?
This data comes from our customers and community members who are currently contacting notified bodies trying to get an offer and appointments for a QMS audit and (class IIa/b) techdoc audit.
Share your notified body experience to help other people.
Choosing a notified body is mired with intransparency. You can change that.