MEDDEV 2.12-1 Rev 5 Reportability Decision Tree? Vigilance Reporting Procedure

Z

zillal - 2011

#1
I work for a medical device manufacturer in the US - our products are CE-marked. I am finishing up our revised Vigilance Reporting procedure and am struggling to come up with a reportability decision tree... MEDDEV 2.12-1 Rev 4 had one in it - but one is not present in Rev 5...

Has anyone seen one? Or do you have one you'd be willing to share?

Anyone else feel like Rev 5 is less clear and more difficult to implement than Rev 4 was?

TIA for any input/assistance!!

*Laurie
Medical Device Regulatory Affairs Manager
 
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W

Watchwait

#5
On a related note, Version 5 of MEDDEV 2-12-1 seems to have done away with the term "near incident". Yet, last year my Notified Body auditor indicated that I need to add the definition of a "near Incident" in my vigilance procedure.

The reading I've done about this indicates that the old concept of a "near incident" (whose definition I was never able to actually find in any vigilance guideline) seems to have been rolled into the broader context of just a plain old "incident". A "near-miss" is now apparently a hit?
 
R

Roland Cooke

#6
This is a useful overview, and includes a table for decision-making.

The terminology, along with several other critical amendments, have completely changed the MDD vigilance requirements. The MEDDEV is of course 'guidance' in name only....
 
W

Watchwait

#7
The terminology, along with several other critical amendments, have completely changed the MDD vigilance requirements. The MEDDEV is of course 'guidance' in name only....
...just wondering about this comment. Legally, I understand MEDDEVs are just that - guidance documents and as such unenforceable.
 
R

Roland Cooke

#8
It states in the introduction of each MEDDEV that it is not legally binding.

But that's not the whole story.

The important thing to remember is that a Notified Body we enforce precisely zero. The most we can do is suspend/withdraw certification and advise the Competent Authority. The Competent Authority is the only body with enforcement action.

But clearly there is a difference between an audit finding and a legal ruling.

We are subject to the rulings of our Competent Authority (the UK MHRA) and they will give us interpretations as and when required (e.g. device classification determinations).

But even those interpretations have no final legal basis unless confirmed in a court case. It almost never goes that far.


The MEDDEVs carry a lot of weight, because the MHRA will expect manufacturers to use these official guidelines, likewise they will expect UK Notified Bodies to use them as audit tools.
 
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