MDD Harmonised Standards (MDD 93/42) not updated since January 2013

[Sam Lazzara]

Does any one else find it strange that in almost one year the MDD harmonised standard listing has not been updated?
http://ec.europa.eu/enterprise/poli...onised-standards/medical-devices/index_en.htm

Was 2013 really that boring?
Or am I missing something?

 

[Marc]

I don't know.

As general info for folks following along - Check the file attachment...
.

 

[Pads38]

An update does seem rather overdue.

As a guess for the reason why it may be delayed is that the committees involved may be waiting and watching for the changes to the directive that have been the subject of discussion and debate over the last year or so.

 

[Ronen E]

An update does seem rather overdue.

As a guess for the reason why it may be delayed is that the committees involved may be waiting and watching for the changes to the directive that have been the subject of discussion and debate over the last year or so.

Correction: It will not be changes to the directive; rather, it will be a complete recast. The new system will be based on "regulations" rather than on "directives".

Cheers,
Ronen.

 

[Pads38]

Ronen, you are correct it is not just a few minor changes but a fundamental revision to how things would be done.

Personally, I am hoping that it will be further delayed and then get side-lined by the EU elections coming in May.