What is the most recent version of MEDDEV 2.4/1 rev8

Hi all, is there anyone who knows if there is a new revision of meddev 2.4/4

Re: MEDDEV 2.4/1 rev8

A revision may be under way (I don't know) but the current valid version is Rev.8 (http :// ec. europa.eu/enterprise/sectors/medical-devices/documents/guidelines/ - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS)

Hello Beele,

depending on why you are after a new version of the meddev 2.4/4, you can also check the different documents on borderline products produced by several European CA. I know for sure that afssaps in France just published a new version lately.

V

Beele said:

Hi all, is there anyone who knows if there is a new revision of meddev 2.4/4

Click to expand...

Hi Beele

the MEDDEV about classification of medical devices is under review as the annex IX of the MDD 93/42/EEC was changed by the directive 2007/47/EC

Please find attached the last drafts for your info (note that are drafts !!)

See the new classification MEDDEV 2.4/1 rev.9 june 2010 just published in the Medical Devices Commision website:

http://ec.europa.eu/enterprise/sectors/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf

Regards

Xavier Canals

Thank's a mill

Revision 2.9 has been published: http://ec.europa.eu/enterprise/sectors/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf