Critical suppliers (Definition of) and MDSAP (Medical Device Single Audit Program)

[Weeder]

Given the definition you posted, it appears that both ARs and NBs (or ABs if you prefer) could be critical suppliers. Is that true?

I was wondering if you received any response to your question regarding both ARs and NBs being critical suppliers?
According to the definition, since an AR supplies services which are needed for compliance with regulatory requirements, they are critical.

 

[Weeder]

Now why the heck would an EC Rep be considered "critical"? What is it that they are required to do (under the MDD, which is still current) that has such a massive effect on anything?... EC Reps essentially exist so that CAs have someone to lay their hands on if something goes terribly wrong. Mostly a legal aspect, if you ask me. It's not like they'd be able to save the day, right?

If we go by the definition, the EC Rep does have a critical role to play. Let us say something goes wrong with your product and it has to be recalled immediately. The EC Rep will be needed to conduct the recall. If the product is not recalled quickly, it could result in harm to patient or user.

 

[Sinus Tarsi]

What are your levels? We have Level 0, Level 1 Crucial, Level 2 Critical

Our NB and AR are Level 1 Crucial.