How does the eMDVR works? To Whom all should the MDV to be reported?

SK13485

MedDev QA/RA
#1
Hi:bigwave:,

We are a small North American manufacturer of Class-2a and 2b devices for Europe. Our devices fall under MDD 93/42/EEC. We have a notified body. Our authorized representative for Europe is based in France.

If there is an adverse event that requires to be reported or an FSCA that need to be initiated under MEDDEV 2.12-Rev:8 criteria, whom all should we report/communicate about the event/actions?

Since the MDVR is currently electronic, which is also known as eMDVR. I am curious to know, how the system works? I understand that a manufacturer's eMDVR will be received by the Notified Body upon its submission. How about the Competent Authorities? Do we need to send the reports to them separately? If so, is it electronic as well? if not, what is the mode of communication?

I understand the present hierarchy like this:
(Manufacturer→AR→NB→MDCG→CA→NCA→Commission)

Your response shall be highly appreciated...:thanx:

Good day !

SK
 
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Marc

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Staff member
Admin
#2
A quick "Bump" - Thanks in advance to anyone who can help with this one.
 

FoGia

Involved In Discussions
#4
I don't know about eMDVR, I guess you're referring to a system that in your mind would be similar to eMDR in the US but it doesn't work like that in Europe. As described in the MEDDEV you mention the adequate adverse events are to be notified to the concerned CA and the CA where the manufacturer/AR is registered (NCA=CA). The commission doesn't play a role in this process. Every competent authority has its own notification procedure which is an interpretation of the MDD.

So to sum up the hierarchy/flow looks like this:
Manufacturer/AR->CAs

Notified adverse events are collected in the EUDAMED.
 

SK13485

MedDev QA/RA
#5
Hi FoGia,

Thank you so much for your reply. I was told by my chief that the Medical Device Vigilance Reporting in EU is currently electronic (eVigilance) via our Notified Body(NB),as informed (verbally) to my chief by the last auditor (EU) during the audit. Our Notified Body and the auditor belong to the same organization.

According to what I was told, the Vigilance reporting is done electronically through the notified body (NB), which requires the manufacturer to have an online account/registration with them. Currently, I couldn't find any document to verify that information or authenticity of that information.

The manufacturer and/or their authorized representative in EU must contact their NB for MIR/Vigilance reporting or FSCA.

I clearly understand the reporting procedure according to the MEDDEV 2.12/8. The guidance on vigilance is old. In one of the presentation slides about EU vigilance, I saw a new MEDDEV is currently on works for the Vigilance reporting which will cover over 400 pages.

Back to my original question, I'm still unsure, if the reporting/FSCA has to be made simultaneously to the CA's as well in this new electronic reporting process. We haven't received any communication from our NB regarding this particular question and We found our "NB" terribly slow in handling customer communications.

I am in the process of creating MDVR/FSCA SOP for Europe. Unless, I get a clear response, backed with supporting evidence, I am going to include the eMDVR process and the routine reporting process with reference to MEDDEV 2.12/8 in my SOP.

As a last resort, I will leave it to the auditor for review.

Thank You,
SK
 

FoGia

Involved In Discussions
#6
Aren't you making a confusion with the upcoming Medical Device Regulation(MDR)? From the moment it goes into effect yes reporting of serious adverse will happen through the EUDAMED (article 92 of the MDR). It's still unclear how access management will work but notified bodies will have access to the safety pertaining to the devices for which they have delivered a certificate. Even in that case AEs are not reported through a NB's portal.
In France I see that AEs have to be transmitted to the CA ANSM via e-mail: Votre declaration concerne un dispositif medical - Vous etes un fabricant, un distributeur - ANSM : Agence nationale de securite du medicament et des produits de sante

Even if the MEDDEV is relatively old it is still valid.
 

SK13485

MedDev QA/RA
#7
I am sorry, if the information I provided had confused you. What I replied in my previous post is according to the information provided to my chief by the last auditor from our NB organization. Unfortunately, I wasn't there that time.

The exact information as yours is what I have communicated with my chief. I cannot really argue on something that my chief is so confident about. So as to develop the whole reporting process into a SOP, MEDDEV 2.12/8 is the only guidance document I have got just as what you're currently refering.I agree with you, No doubts on that..

The information I have provided is purely based on the verbal communication by my chief and the auditor at the time of last audit. Here, I was asking if somebody know about this change or atleast the going-to-be-change for Vigilance reporting?

Our recent communications with the NB was made electronically. That is what I know for sure. At this point, the thing I'm unsure is about how much control our NB's have in this Vigilance reporting process and their interaction with CA's,MDCG's and Commission.

The EUDAMED as manufacturer information sharing portal for public and Electronic databank is currently in works. For now, this system communication is currently active between NCA's and Commission for NCAR's.

Just as I said in my second post, I will leave it for the auditor to review as our audits are approaching. Thank you for your input, much appreciated!

Good day !
SK
 
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