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EU Medical Device Vigilance Reporting Requirements

T

tyred60

#1
Hi all,

Wonder if someone can help with this issue:

A manufacturer of medical devices in the UK sells his product through an agent in another EU state. A incident arises with that product that requiries reporting under vigilance. The incident is reported by the hostpital to the agent who in turn notifies the UK manufacturer, who notifies the MHRA.

Question: who's responsibility is it to report the incident to the competent authority in the member state where the incident occured? The UK manufacturer has relied on their agents in each member state to do this, primarily because of language issues - is this correct as they have been advised by their regulatory authority this is not acceptable?

Do the MHRA not have a duty to circulate details of the incident to the competent authorities in the other member states?

Have read 93/42/EEC, 2007/47/EU and MEDDEV2.12/1 rev6 which would seem to indicate that the manufacturer should notify the relevant competent authorities in each EU state - if so this raises significant language difficulties.

Clarification anyone?:confused:
 
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rob73

looking for answers
#2
The way I have always understood it, is that the manufacturer or their authorised representative notifies the competent authority in which the incident occurred (within the EU).
Is the agent designated as an authorised representative? MEDDEV 2.12 defines this quite clearly. If there is an authorised representative they should be able to handle the report on the manufacturers behalf, if not the manufacturer must deal with the competent authority.

Rob
 

Ronen E

Problem Solver
Staff member
Moderator
#3
The way I have always understood it, is that the manufacturer or their authorised representative notifies the competent authority in which the incident occurred (within the EU).
Is the agent designated as an authorised representative? MEDDEV 2.12 defines this quite clearly. If there is an authorised representative they should be able to handle the report on the manufacturers behalf, if not the manufacturer must deal with the competent authority.

Rob
Hi,

As noted in the OP, the manufacturer is located in the UK, and as such an authorized representative is not required.

In my understanding, the manufacturer (if located in the EC; otherwise the EC rep.) should be dealing with the competent authority in their own member state. With Eudamed becoming operationally mandatory in May 2011, any competent authority is obliged to upload any reportable event data to Eudamed, through which it is available online to all other competent authorities. I'm not sure of the actual access to such data by any/all competent authorities (i.e. whether or not they actually actively and continuously monitor Eudamed for new reportable events), however, once uploaded to Eudamed it should be available to all, and I reckon that would relieve the manufacturer (or EC rep.) from any further reporting to competent authorities in other member states.

The above is *NOT* an official statement whatsoever, just my opinion.

Cheers,
Ronen.
 
Last edited by a moderator:

Marcelo

Inactive Registered Visitor
#4
It's the manufacturer's responsibility, but this does not mean that he has to perform the action. He could delegate the authority to do so to their agent in the specific countries.
 
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