Has the update to MDD 93/42/EEC been released yet?

[Quality Priest]

Hi,

Any one know if the update to MDD 93/42/EEC, has been released yet?
Cant seem to find any update.

Thanks

 

[Gert Sorensen]

Re: MDD 93/42/EEC Update

Which update are you referring to? The 2007 update or the one planned for 2014?

 

[Quality Priest]

Re: MDD 93/42/EEC Update

I thought that there was one planned for 2013 or is that just consultancy for the changes?

 

[Gert Sorensen]

Re: MDD 93/42/EEC Update

As far as I know, publication is scheduled for 2014 with an effective date of 2017.

 

[Quality Priest]

Re: MDD 93/42/EEC Update

Ah great understood it was 2017 for implementation.

Thank you!

 

[Ronen E]

Re: MDD 93/42/EEC Update

PS It's not an update to the directive; it's a move from the directive to a regulation (not the same thing).

 

[SteveK]

Hi,

Any one know if the update to MDD 93/42/EEC, has been released yet?
Cant seem to find any update.

Thanks

If you want to look at the "Proposal" go to:

https://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_542_en.pdf

Steve

 

[Gert Sorensen]

Ronen is right - it is not a directive, so it's a whole new playing field

Here's a link to Emergo's whitepaper on the matter. It makes for interesting reading:
https://www2.emergogroup.com/white-paper-europe-proposed-regulation

 

[renenatasha]

Good day.

WTA - Does anyone know the latest status of the proposed regulation? Any lead from the last post back in 2013?

Thanks and have a great weekend ahead. - Rene

 

[SteveK]

Hi Rene,

Have a look at this link:

https://medicaldeviceslegal.com/

Steve