MEDDEV 2.12-1 Revision 6 Released

[bio_subbu]

Dear All

The European Commission has published revised versions of Medical Devices Vigilance system guidance document MEDDEV 2.12-1 Rev. 6. The revision to this guidance is restricted only to technical modifications to Annex 3 (the 'Report Form - Manufacturer's Incident Report').

Regards
S. Subramaniam

 

[DannyK]

I really appreciate the update.

Thanks.

 

[arios]

Me too Subbu, many thanks

It is not a surprise to find that you always on the top when it comes to updates

Muchas Gracias! Shukria!

 

[sreenu927]

Thanks bro..
got it at right time..iam in midst of preparing a global procedure for FSCA or MDR which covers all major countries..the diff is reporitng timelines and US FDA MDR reporting is a bit different.

thanks once again.

Cheers
Sreenu

 

[michm9]

I am attempting to revise our Advisory Notices, Recall & Vigilance procedure to bring it into compliance with Rev. 6. I am really having a tough time. Do you advise having one procedure for MDD and one for FDA? Or, does someone have a sample procedure that consolidates both the EU and US requirements? Any suggestions will be appreciated.
Thanks.

 

[dchoices]

Thanks for this info. It came in handy to update our complaint SOP.

 

[pacific2010]

I am writing an Incident Reporting procedure. Should I be following MEDDEV 2.12-1 REV 5 or REV 6? What are the major differences.

Any help would be greatly appreicated!

 

[dchoices]

Follow Rev 6 of MEDDEV 2.12-1. The only difference is the Report Form - Manufacturer's Incident Report found in Annex 3. This revision is applicable as of 20 March 2010.

 

[Nort1]

I am attempting to revise our Advisory Notices, Recall & Vigilance procedure to bring it into compliance with Rev. 6. I am really having a tough time. Do you advise having one procedure for MDD and one for FDA? Or, does someone have a sample procedure that consolidates both the EU and US requirements? Any suggestions will be appreciated.
Thanks.

I prefere to have the MDR and Vigilance Reporting in different procedures. This makes it clearer to address the specifics of each system (EU vs. FDA).

However, you might have reasons, based on your device distribution, to combine the two.

Norbert

 

[Roland Cooke]

Note that this was issued in December 2009, and became active from March 2010.

If your current policy is to review MEDDEVs online on an annual basis....you might wanna rethink that.