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Notified Body audits -Class Ia medical device product

MedicalDevice

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#1
Hey everyone.
I am currently in the process of closing an agreement with an EU Rep. since I am marketing some products outside of Europe and thus, I need an EAR.
Could you please inform me if a class Ia medical device product, needs to be audited (class I=self-declaration)? Or am I only required to have the technical files for it reviewed and approved by my European Authorized Representative?

Thank you in advance for your time and help!
 

Ronen E

Problem Solver
Staff member
Moderator
#2
Could you please inform me if a class Ia medical device product, needs to be audited
(Under assumption that you meant IIa - I don't know what Ia means)

Yes, if that device is intended to be placed on the EU market, it will need to be certified by a NB, i.e. audited.

Having asked this question, I strongly advise that you either hire a knowledgeable employee to deal with regulatory affairs, or engage with a consultant. There will be many questions like this one, and more complicated, along your (legal) path to the market.
 
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Ronen E

Problem Solver
Staff member
Moderator
#4
Class I devices don't require external audit unless they have a measuring function or are provided sterile or are intended for reprocessing (cleaning etc.) after each use.

The MDR doesn't explicitly require the European Authorized Representative to review and approve your technical files, but it's apparently implied that they'd have no other choice if they wanted to comply with the MDR:
The mandate shall require [...] the authorised representative to perform at least the following tasks in relation to the devices that it covers:
[...]
(h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
If no other external body (e.g. a NB) will vouch for the technical files actually meeting "the manufacturer's obligations under the MDR", I don't see any other way for the EAR to tell whether these obligations are met and thus whether they need to terminate.

Whether or not EARs are actually interpreting the MDR this way, I do not know.
 
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#5
My understanding is that a lot more liability (legal or regulatory, I don't know) has been allocated to the EARs under the MDR, so they are being far more diligent and demanding than previously. However, this liability may not come into play (legally or pragmatically) with Class I devices. On the other hand, maybe even more so, since no NB has the EAR's back. Anyone know?
 
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