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Revised MEDDEV 2.12-1 rev 8 Vigilance System - Released

sreenu927

Quite Involved in Discussions
#1
Hi All,

EU has released a revised MEDDEV Guidance document for Vigilance System
2.12-1 rev.8.

"Revision 8 of MEDDEV 2.12-1 explicitly includes IVF/ART devices within the scope of the vigilance system and provides clarity in relation to devices that are not intended to act directly on the individual. The revised guidance will be applicable as of July 2013."

Regards,
Sreenu
 

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Elsmar Forum Sponsor
Q

Quarma

#2
Hi all,
the guideline doesn't bother to spell out the abbreviations used,
so here is what they were adding:

in vitro fertilization (IVF) and assisted reproductive technologies (ART),
 

lboll

Involved In Discussions
#4
I've gone through revision 8 and compared it to revision 7. My notes on the changes are attached. I found 8 differences all related to IVDs, IVF/ART, or diagnostic devices.

None of the report formats in the Annexes have changed.

My disclaimer: Our company does not manufacture IVDs, IVF/ART, or diagnostic devices, so I went into this review expecting no impact on our company and may have done the review a little quicker than I would have if I expected some impact.
 

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