How to select your Notified Body and understand the full process?
The selection of Notified Bodies in Europe can be a real challenge and I will explain to you in this Podcast episode how to do it so you can understand the process and get the real outcome for your projects.
There are 33 Notified Bodies for EU MDR 2017/745 at the time of this podcast. This is lower than the number of Notified Bodies that were under EU MDD 93/42/EC so this means that there will be a big bottleneck. So let us help you go over it and really make the right decisions.
To get all the information about this process with Notified Bodies, go to the Annex VII of the EU MDR and IVDR
Who is Monir El Azzouzi?
Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company is also acting as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.
Links
- NANDO Database: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
- First audits conclusion episode with Martin Witte: https://podcast.easymedicaldevice.com/140/
- Qualitiso Notified Body price: https://www.qualitiso.com/en/comparison-of-notified-body-fees/
- EU MDR link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20220128#tocId166
- Technical File Episode: https://podcast.easymedicaldevice.com/191/
- Expert Panel Episode with Bassil Akra: https://podcast.easymedicaldevice.com/102/
- First results of Expert Panel Episode with Bassil Akra: https://podcast.easymedicaldevice.com/136/
- TÜV SÜD pre-application form: https://www.tuvsud.com/en/industries/healthcare-and-medical-devices/medical-devices-and-ivd/medical-device-market-approval-and-certification/medical-device-regulation/mdr-request-for-service-registration
2 Replies to “How to select your Notified Body and understand the full process?”
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Hi Monir,
thanks for the very educational video. It helps a lot to give orientation within a complicated topic.
One detailed question: Notified bodies often offer conformity assessment support and an ISO 13485 certification within the same customer request template. Are ISO 13485 certificates mandatory/optional/recommendable to have beside the conformity assessment support? What is your experience?
Kind Regards
Reinhard
Hi Reinhard, thanks for your message. Regarding your quedtion I would say ISO 13485 is mandatory even if standards are voluntary. Why? Because all notified bodies are expecting you to have it. And if you don‘t there will be a difficult moment for you and for the Notified body as they‘ll need to do a deeper review of your QMS. And nobody wants that. So just apply ISO 13485 to be on the safe side