The Elsmar Cove Forum and Site Map The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page

Go Back   The Elsmar Cove Forum > National and International Business Standards > CE Marking (Conformité Européene) / CB Scheme
Reload This Page The status of the 2005 ammendments to the MDD (Medical Device Directive)?
Register Photo AlbumsBlogs FAQ Registered Visitors Social Groups Calendar Search Today's Posts Mark Forums Read


The Elsmar Cove Forum SideBar!
Monitor the Forum
Monitor New Forum Posts
New Threads Feeds
RSS FeedRSS Feed
Sponsor Link










$ Contributor Forum Access
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

Howard's International Quality Services

Atul's Symphony Technologies

Dave Scott's Scott Quality Solutions

Praxiom Research Group

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest Portal

IEST - Institute of Environmental Sciences and Technology

ASQ - American Society for Quality

All the Important Standards and Related Web Sites in the World
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  #1  
Old 23rd July 2007, 06:23 AM
chris1price chris1price is online now
Courtesy Access

Registration Date: Dec 2005
Location: Berks, UK
  
Posts: 130
Thanks Given to Others: 29
Thanked 98 Times in 59 Posts
Karma Power: 26
Karma: 417
chris1price is appreciated, and has over 400 Karma points.chris1price is appreciated, and has over 400 Karma points.chris1price is appreciated, and has over 400 Karma points.chris1price is appreciated, and has over 400 Karma points.chris1price is appreciated, and has over 400 Karma points.
Please Help! The status of the 2005 ammendments to the MDD (Medical Device Directive)?
Hi All

Does anyone know the status of the 2005 ammendments to the MDD? When will they become effective and will there be a transition period?
Reply With Quote

Sponsored Links
  #2  
Old 23rd July 2007, 09:57 PM
harry harry is online now
Super Moderator

Registration Date: Sep 2005
Location: Johore/Malaysia
  
Posts: 2,946
Thanks Given to Others: 572
Thanked 1,031 Times in 746 Posts
Blog Entries: 1
Karma Power: 231
Karma: 7783
harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.
harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.harry is appreciated, and has over 1700 Karma points.
Default Re: The status of the 2005 ammendments to the MDD (Medical Device Directive)?
Is the attached document what you are looking for?
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting the post it is in, 3. Use at your Own Risk.
File Type: pdf uksiem_20070400_en.pdf (102.4 KB, 34 views)
Reply With Quote
Thank You to harry for your informative Post and/or Attachment!
Sponsored Links

  #3  
Old 23rd July 2007, 10:33 PM
Ajit Basrur's Avatar
Ajit Basrur Ajit Basrur is offline
Super Moderator

Registration Date: Dec 2005
Location: India
Age: 46
  
Posts: 2,647
Thanks Given to Others: 674
Thanked 803 Times in 579 Posts
Karma Power: 176
Karma: 5448
Ajit Basrur is appreciated, and has over 1700 Karma points.
Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.Ajit Basrur is appreciated, and has over 1700 Karma points.
Default Re: The status of the 2005 ammendments to the MDD (Medical Device Directive)?
The latest news on this was that the commission launched the much awaited revision on 22 Dec 2005 - http://europa.eu/rapid/pressReleases...guiLanguage=en

The Commission proposal was to be forwarded to the European Parliament and Council for co-decision.
__________________
I have no special talents. I am only passionately curious - Albert Einstein
Reply With Quote
Thanks to Ajit Basrur for your informative Post and/or Attachment!
  #4  
Old 24th July 2007, 05:08 AM
chris1price chris1price is online now
Courtesy Access

Registration Date: Dec 2005
Location: Berks, UK
  
Posts: 130
Thanks Given to Others: 29
Thanked 98 Times in 59 Posts
Karma Power: 26
Karma: 417
chris1price is appreciated, and has over 400 Karma points.chris1price is appreciated, and has over 400 Karma points.chris1price is appreciated, and has over 400 Karma points.chris1price is appreciated, and has over 400 Karma points.chris1price is appreciated, and has over 400 Karma points.
Default Re: The status of the 2005 ammendments to the MDD (Medical Device Directive)?
Thanks guys, I knew about the reclassification of orthopaedic implants. It was the more complete overhaul I was intested in. The attached file shows all the ammendments.

http://ec.europa.eu/enterprise/medic...tion_draft.pdf

There is a lot of subtle changes in here that we need to be aware of. eg software and clinical trials. These are relevant to me but other people may pick out more points of interest.

If anyone hears a date for adoption, can they post it.
Reply With Quote
  #5  
Old 9th August 2007, 05:23 AM
wrodnigg's Avatar
wrodnigg wrodnigg is offline
CE or not CE?

Registration Date: Nov 2003
Location: Vienna, Austria
  
Posts: 211
Thanks Given to Others: 4
Thanked 123 Times in 36 Posts
Karma Power: 43
Karma: 706
wrodnigg is appreciated, and has over 700 Karma points.wrodnigg is appreciated, and has over 700 Karma points.wrodnigg is appreciated, and has over 700 Karma points.wrodnigg is appreciated, and has over 700 Karma points.wrodnigg is appreciated, and has over 700 Karma points.wrodnigg is appreciated, and has over 700 Karma points.wrodnigg is appreciated, and has over 700 Karma points.
Default Re: The status of the 2005 ammendments to the MDD (Medical Device Directive)?
The revision of the MDD has passed the European Parliament on March 29. 2007.

I am awating the publishing of the new directive in the EU-Journal since a couple of weeks (ist should be published this or next month).

The directive has to be translated into 25 languages, reviewed and so on...
this process takes time...

I you are interested, I could look for the parliamental text...

~ghw
__________________
regards~ghw
Reply With Quote
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > National and International Business Standards > CE Marking (Conformité Européene) / CB Scheme
Reload This Page The status of the 2005 ammendments to the MDD (Medical Device Directive)?

Bookmarks

« Previous Thread | Next Thread »

Visitors Currently Viewing this Thread: 1 (0 Registered Visitors and 1 Unregistered Guests)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Linear Mode Linear Mode
Rate Thread Content:

Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts
BB code is On
Smilies are On
[IMG] code is On
HTML code is Off
Forum Jump

Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
MDD (Medical Device Directive) Update? The copy I have is 14 June 1993 (93/42/EEC) echo7tango Other ISO and International Standards and European Regulations 13 23rd September 2008 03:30 AM
MDD (European Medical Device Directive) requires subset of ISO 13485 s.parakos ISO 13485 - Medical Devices - Quality Management Systems 10 4th September 2007 11:08 AM
Getting Started - ISO13485:2003 and MDD (Medical Device Directive) DAMAS ISO 13485 - Medical Devices - Quality Management Systems 9 17th July 2007 03:15 AM
Canadian Medical Device Reg & Medical Device Directive Comparison To FDA Regulations Al Rosen ISO 13485 - Medical Devices - Quality Management Systems 11 24th February 2007 10:58 PM
Medical Device Directive - Anyone know of any good MDD training courses qagirl Training - Internal, External and Distance Learning 11 26th May 2005 02:36 AM



The time now is 08:45 AM. All times are GMT -4.
The time zone can be changed in your UserCP --> Options.

Contact Marc - Elsmar Cove Site Home Page - Elsmar Cove Index (Ar) - Privacy Statement - Top


   

All Y'All Come Back Now, Y' Hear?

Made With A Mac! FreeBSD OS Powered by Apache!
Using php4 Forums provided and maintained by Marc Smith Database by MySQL

FAIR USE and CORRECTNESS NOTICE: This site contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of environmental, political, human rights, economic, democracy, scientific, and social justice issues, etc. We believe herein constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. For more information go to: http://www.law.cornell.edu/uscode/17/ If you wish to use copyrighted material from this site for purposes of your own that go beyond 'fair use', you must obtain permission from the copyright owner. In addition, I do not guarantee the correctness of the content. The risk of using content from the Elsmar Cove web site and forums remains with the user/visitor.

Responsibility Statement: Each person is responsible for anything they post in the Elsmar Cove forum. Neither I, Marc Timothy Smith, nor any of the forum Moderators, are responsible for the content of posts people make. Liability for post content resides with the poster as does interpretation and/or acceptance and/or use of advice by the reader.

Complaints: If you have a complaint with a post in a forum discussion thread, including Content in general, fighting, flaming, copyright infringement, defamation and/or 'slander', please use the 'Report This Post Report This Post Button button which appears at the top of every post in every thread.
Site courtesy of:
Marc Timothy Smith - Cayman Business Systems, 8466 Lesourdsville-West Chester Road, West Chester, Ohio 45069-1929 - USA
(513) 341-6272

To contact me, click the Google Voice link below, enter Your Name and Your Phone Number and Google will ring your phone and connect you for free!
The Elsmar Cove Web Site is *CopyFree*
no new posts