Hello Friends,

Recently my auditors told me to update my vigilance procedure with respect to rev 5 of 2.12. 1.

Is it compulsory for the manufacturers who produces CE mark products or earlier version of MDVS is sufficient?

Regards,
Raghu:rolleyes:

The Guideline MEDDEV 2.12-1 rev 5 has entered into force on 1st January 2008, therefore you should revise your vigilance system procedure to meet the revised requirements.

Amjad Rana

Guidelines are not compulsory so you really do not have to update (and your auditor should really told you that it would be wise to analyse the modifications and decide if an update is needed). It´s always easier, though (and a good practive also), to accept a system based on the more recent one.

Can anybody summarise the main changes that have occurred in this version?

It's probably too involved to summarise to be honest. It is however well written (and free!) so you shouldn't have any problems upgrading your systems.

Whilst mmantunes is technically correct, in that the MEDDEVs are "only" guidance, as a Notified Body we won't be accepting anything less than full compliance.

It's the same as having ISO13485 for Annex II. No, strictly speaking, you don't need to comply with it, but it is the audit tool we will be using, so you don't really have a choice in that regard.