The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
Class I Medical Device into a higher class (IIa or IIb)
UL - Underwriters Laboratories - Health Sciences
Class I Medical Device into a higher class (IIa or IIb)
Class I Medical Device into a higher class (IIa or IIb)
Class I Medical Device into a higher class (IIa or IIb)
Class I Medical Device into a higher class (IIa or IIb)
Class I Medical Device into a higher class (IIa or IIb)
Class I Medical Device into a higher class (IIa or IIb)
Class I Medical Device into a higher class (IIa or IIb)
Class I Medical Device into a higher class (IIa or IIb)
Class I Medical Device into a higher class (IIa or IIb)
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Class I Medical Device into a higher class (IIa or IIb)


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

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

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 i medical device, class ii medical device, medical devices
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 31st August 2016, 04:55 AM
MDD_QNA

 
 
Total Posts: 29
Question Class I Medical Device into a higher class (IIa or IIb)

Dear all,
What would be the reason to buy a product that is of class I and make it into a class II device? I have been asked to look into this matter. We have a pharmaceutical (lotion) that is used together with a lamp. This lamp is a class I device right now. And I am looking into what the requirements are to make it into a class II device.
Will the new regulation have any effect on the matter?
I have no idea about this lamp as for now.

Very grateful for your input!

Sponsored Links
  Post Number #2  
Old 31st August 2016, 05:00 AM
Ronen E

 
 
Total Posts: 3,386
Re: Class I into a higher class (IIa or IIb)

If a given device is classified properly, there is no way you can force-classify it into another class unless you change its design or its intended use.

What would your company gain from having the lamp classified as >1?
Sponsored Links

  Post Number #3  
Old 31st August 2016, 06:40 AM
MDD_QNA

 
 
Total Posts: 29
Please Help! Re: Class I Medical Device into a higher class (IIa or IIb)

Ok, so the design will remain the same and we will add one indication to it. It will probably become a class IIa device, so what are the requirements compared to class I, when it comes to documentation?
Probably 60601-testing and EMC, particular 2-57, clinical data, IFU/label update. What else?

Edit: right now the lamp is used as an overhead lighting for surgery and it will have a new intended use of treating a disease.

Last edited by MDD_QNA; 31st August 2016 at 10:41 AM.
  Post Number #4  
Old 31st August 2016, 11:01 AM
mihzago

 
 
Total Posts: 140
Re: Class I Medical Device into a higher class (IIa or IIb)

Clinical data is required for all classes, see MEDDEV 2.7/1 rev. 4.

You will also need a Notified Body involvement to review your tech file and issue the EC Cert.

there may be other things.
Thank You to mihzago for your informative Post and/or Attachment!
  Post Number #5  
Old 31st August 2016, 08:15 PM
Ronen E

 
 
Total Posts: 3,386
Re: Class I Medical Device into a higher class (IIa or IIb)

Quote:
In Reply to Parent Post by MDD_QNA View Post

It will probably become a class IIa device, so what are the requirements compared to class I, when it comes to documentation?
Probably 60601-testing and EMC, particular 2-57, clinical data, IFU/label update. What else?
With all due respect, I think that your approach isn't right.

In the EU (which I assume is your regulatory context in this discussion) class I devices and class IIa devices are treated quite differently. My advice - forget that the lamp was ever classified as class I. Look at it as it is, with the newly added intended use, and analyse your regulatory situation accordingly. Study the relevant MDD requirements and verify that all are met. Some will already be covered as part of the class I compliance, but the gaps are likely to be significant.

Probably the biggest difference is the obligation to get a NB involved.
Thanks to Ronen E for your informative Post and/or Attachment!
  Post Number #6  
Old 1st September 2016, 05:33 AM
MDD_QNA

 
 
Total Posts: 29
Question Re: Class I Medical Device into a higher class (IIa or IIb)

And how do we determine what annex to follow? A similar device we have we use Annex V and VII.
  Post Number #7  
Old 1st September 2016, 05:38 AM
MDD_QNA

 
 
Total Posts: 29
Re: Class I Medical Device into a higher class (IIa or IIb)

Quote:
In Reply to Parent Post by Ronen E View Post

With all due respect, I think that your approach isn't right.

In the EU (which I assume is your regulatory context in this discussion) class I devices and class IIa devices are treated quite differently. My advice - forget that the lamp was ever classified as class I. Look at it as it is, with the newly added intended use, and analyse your regulatory situation accordingly. Study the relevant MDD requirements and verify that all are met. Some will already be covered as part of the class I compliance, but the gaps are likely to be significant.

Probably the biggest difference is the obligation to get a NB involved.
What is the GAP in terms of documentation? What is the difference in documentation requirement?
  Post Number #8  
Old 1st September 2016, 09:00 AM
Ronen E

 
 
Total Posts: 3,386
Re: Class I Medical Device into a higher class (IIa or IIb)

Quote:
In Reply to Parent Post by MDD_QNA View Post

And how do we determine what annex to follow? A similar device we have we use Annex V and VII.
If indeed the lamp is classified as IIa, and you don't actually make it or physically change anything in it, you could probably do with Annex VI instead of Annex V (and it's a little less burdensome). You could, however, keep it under Annex V and exclude the parts that are not relevant.
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
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
Device Class when used in combination with a device of a higher class? icare2much 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11 30th July 2012 01:58 PM
Can a Predicate device be a higher class? Sheppi76 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8 20th July 2012 10:15 AM
Change Medical Device Class from Class II to Class I AJayC 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8 2nd December 2011 04:39 PM
Medical Device Registration Process in Italy - Class I and Class II Medical Devices ISO 13485 - Medical ISO 13485:2016 - Medical Device Quality Management Systems 2 21st May 2011 03:05 AM



The time now is 12:44 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 
 
 


NOTE: This forum uses "Cookies"