The Cove Business Standards Discussion Forums
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

MDD 93/42/EEC and Leather - CE-marking our (class I) product

Monitor the Elsmar Forum
Courtesy Quick Links

Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services

International Quality Services

Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum

Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining

Ajit Basrur
Claritas Consulting, LLC

International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology

Some Related Topic Tags
leather, mdd (medical device directive), mdd 93/42/eec
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 18th March 2009, 10:30 AM

Total Posts: n/a
Please Help! MDD 93/42/EEC and Leather - CE-marking our (class I) product


I'm new on the forum so please forgive me if this is the wrong subforum.

My company is heading for CE-marking our (class I) product. One question that has come up is about point 8.2 in the essential requirements of the MDD. Is ordinary leather used for clothing etc. considered as animal tissues that have to be subjected to veterinary control?

Best Regards, Johan

Sponsored Links
  Post Number #2  
Old 18th March 2009, 11:03 AM

Total Posts: 3,685
Re: MDD 93/42/EEG and leather

Do you have adequate evidence in your technical file that your intended use will be riskless in regard to "veterinary controls and surveillance adapted to the intended use of the tissues"?

If there is evidence of no risk, then I'd guess it could reasonably be determined that the required extent of "veterinary controls and surveillance" would be none.
  Post Number #3  
Old 20th March 2009, 02:26 AM
Roland Cooke

Total Posts: 614
Re: MDD 93/42/EEC and Leather - CE-marking our (class I) product

Those devices are given a pass, see page 40 of MEDDEV 2.4/1
Thanks to Roland Cooke for your informative Post and/or Attachment!

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >


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

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

Forum 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
Emoticons are On
[IMG] code is On
HTML code is Off

Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Electrical Class (Class I, II & III) vs. Medical Device CE marking Class I, II & III LuckyK ISO 13485:2016 - Medical Device Quality Management Systems 3 6th January 2015 12:43 PM
Help with Medical Device Class IIa Annex V CE Marking 58431Check Document Control Systems, Procedures, Forms and Templates 1 17th August 2013 11:26 PM
Class I Medical Device - What is in a CE Marking Self-Declaration Carisa EU Medical Device Regulations 18 10th March 2009 05:46 PM
CE Marking for Wood Product - One for each product?, Self Declare? trusti - 2009 CE Marking (Conformité Européene) / CB Scheme 11 28th October 2008 11:15 PM
CE Marking for Class I Medical Devices - Self-declare CE marking? melisa7421 EU Medical Device Regulations 4 4th January 2007 07:25 PM

The time now is 04:09 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.

Misc. Internal Links

NOTE: This forum uses "Cookies"