The Cove Business Standards Discussion Forums
Inform NB of change to Indications of Use, but change is not a medical feature
UL - Underwriters Laboratories - Health Sciences
Inform NB of change to Indications of Use, but change is not a medical feature
Inform NB of change to Indications of Use, but change is not a medical feature
Inform NB of change to Indications of Use, but change is not a medical feature
Inform NB of change to Indications of Use, but change is not a medical feature
Inform NB of change to Indications of Use, but change is not a medical feature
Inform NB of change to Indications of Use, but change is not a medical feature
Inform NB of change to Indications of Use, but change is not a medical feature
Inform NB of change to Indications of Use, but change is not a medical feature
Inform NB of change to Indications of Use, but change is not a medical feature
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Inform NB of change to Indications of Use, but change is not a medical feature


Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


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

Jennifer Kirley's
Conway Business Services


Howard's
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
class ii medical device, mdd (medical device directive), mdr (medical device regulations)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 16th May 2018, 07:36 AM
Asherlee

 
 
Total Posts: 62
Question Inform NB of change to Indications of Use, but change is not a medical feature

A Class IIa medical device has two medical features approved by the NB for CE marking. The manufacturer now wants to add a new feature to the device, but is claiming that the new feature has a wellness function only and does not fall within the definition of a medical device as set out in the MDD or MDR.

So while the new feature is a "substantial"change since it changes the spec. of the device and the Indications for Use for the device, the new feature is not intended to have a medical function (this claim is supported by the labeling).

Question: does the manufacturer have to inform the NB of the new/wellness feature?

Thanks

Asherlee

Sponsored Links
Reply

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

Bookmarks



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
Product Evaluation Requirements for Change in Manufacturing Facility/Change in Design v9991 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 12 11th August 2013 09:13 AM
New 510k requirements for Change in Indications for Use robert.beck 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4 12th November 2012 10:48 AM
Change Control Training - Change Control for Medical Devices Philipp Training - Internal, External, Online and Distance Learning 6 11th March 2011 06:07 AM
Equipment Change or Process Change? Validation protocol for a planar freezer RV123 Misc. Quality Assurance and Business Systems Related Topics 3 9th October 2008 09:50 AM
ECO (Engineering Change Order) Revision - Letter change or part number change? kcmomde Manufacturing and Related Processes 13 28th July 2008 05:39 PM



The time now is 02:36 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"
The Elsmar Cove web site and all content is owned by Rabbithash Corp. as of 1 MAY 2018.
Unlike Facebook and other properties such as Linkedin, We don't buy, sell, or "share" visitor information. Never have, Never will...
GDPR Compliant since 1996, keeping Marc's vision alive!