Hi Mahamad - happy to help. You may check out the following link of approved notified bodies and the types of products they have expertise with [http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.pdf&refe_cd=93%2F42%2FEEC&requesttimeout=900]. You will need to identify what your medical device or product is, and narrow the list to at least three (3) or more who you can qualify for the requirements of your company. I have found that you can conduct an internet search and locate the main email or phone number to call for business development/account reps in your area. You will want to establish if they have the skills and time to be your notified body. You can ask what their basic fee structure is. They rarely give advice these days and don't really have consulting since things are much more strict now. Some notified bodies are better than others in getting back in touch with you. Give it a shot and let me know how things go for you! Cheers, Alethea Wieland, President and Founder, www.clinicalresearchstrategies.com/about.html

This is an age-old question, and the answer is getting more complicated as time goes on, particularly with the implementation of the new medical device regulations in Europe. I have prepared a few blog posts on this topic that may be of interest.

Notified Body Selection Guide
https://mdqc.com/european-notified-body-selection-guide/

Notified Body Sleuthing
https://mdqc.com/notified-body-sleuthing/

Notified Body Selection Advice
https://mdqc.com/notified-body-selection-advice/
Caution - Nowadays it is highly unlikely your candidate NB will let you interview your potential NB auditors before you select your NB. Back in the old days, it was possible.

Thanks Alethea and sam

Another consideration in your selection process is to determine if MDSAP certification will be needed now or in the future. Only 14 organizations are identified by Health Canada as MDSAP auditing organizations. It would be a shame to select a NB, and then need to transfer because they cannot offer MDSAP certification. The list of MDSAP auditors can be found at:
https://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM429978.pdf
Intertek provided quick quotes recently, and LNE/GMED seems to serve smaller clients well. But most of the organizations are very slow to provide quotes while they are going through the NB designation process under the new regulations.

Hi Mahamad. I wrote this piece explaining the questions to ask, decision points, and appropriate answers when selecting a Notified Body. https://leanraqa.com/regulatory-quality/swipe-right-left-notified-body/
It is informative and a fun read. Let me know if I can help.

Just a follow on to Rob's point about if you also need a MDSAP certification to select from the list he referenced. Vice Versa, not every Audit Organization on the MDSAP list has also maintained designation as a Notified Body. For example, Intertek lost their MDD designation some time ago and to my knowledge is not applying for MDR designation to issue CE marks.

Thanks Michelle and Robert