The Cove Business Standards Discussion Forums
Meaning of Annex II, excluding point Clause 4 conformity
UL - Underwriters Laboratories - Health Sciences
Meaning of Annex II, excluding point Clause 4 conformity
Meaning of Annex II, excluding point Clause 4 conformity
Meaning of Annex II, excluding point Clause 4 conformity
Meaning of Annex II, excluding point Clause 4 conformity
Meaning of Annex II, excluding point Clause 4 conformity
Meaning of Annex II, excluding point Clause 4 conformity
Meaning of Annex II, excluding point Clause 4 conformity
Meaning of Annex II, excluding point Clause 4 conformity
Meaning of Annex II, excluding point Clause 4 conformity
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Meaning of Annex II, excluding point Clause 4 conformity


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
annex ii, mdd 2007/47/ec, mdd 93/42/eec
Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 1 votes, 5.00 average. Display Modes
  Post Number #1  
Old 14th March 2018, 03:24 AM
Harini17

 
 
Total Posts: 15
Please Help! Meaning of Annex II, excluding point Clause 4 conformity

Dear Experts,

It would be great if you could explain me what is the meaning of this:

Annex II, excluding point Clause 4 conformity assessment route of EC Council Directive 93/42/EEC, as amended by 2007/47/EC concerning medical
devices.


Why this needs to be included in the CERs?

Looking forward to hear from you soon.

Thank you

Sponsored Links
  Post Number #2  
Old 14th March 2018, 10:14 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,231
Re: Meaning of Annex II, excluding point Clause 4 conformity

It would be easy to help if you mentioned where the text is from.
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #3  
Old 14th March 2018, 10:32 AM
Harini17

 
 
Total Posts: 15
Re: Meaning of Annex II, excluding point Clause 4 conformity

Hi,

Thanks for your reply.

I was reading one of the CERs of Class II-b device, there I could see this information. When I saw this in MDD 93/42/ EEC Article 11 section 3 mentions the same. Is it important to include in the CER?

Also it would be great if you could clarify the inclusion of similar devices in the literature review section. I couldn't find the convincing answer for this from the Regulatory standpoint. Most of them say that we shouldn't include as we are not claiming equivalence with those devices and say it is only required for state of the art section. I have seen inclusion of similar device in many CERs. If you could answer this with relevant justification, it would be more helpful.

Looking forward to hear from you

Thank you
  Post Number #4  
Old 14th March 2018, 12:33 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,231
Re: Meaning of Annex II, excluding point Clause 4 conformity

Quote:
In Reply to Parent Post by Harini17 View Post

Hi,

Thanks for your reply.

I was reading one of the CERs of Class II-b device, there I could see this information. When I saw this in MDD 93/42/ EEC Article 11 section 3 mentions the same. Is it important to include in the CER?

No, this has nothing to do with the CER. It's only there (and 11 only details the conformity assessment routes) to define that "4. Examination of the design of the product"on Annex II is not applicable to class IIb devices if you follow 11.3.a).

Quote:
Also it would be great if you could clarify the inclusion of similar devices in the literature review section. I couldn't find the convincing answer for this from the Regulatory standpoint. Most of them say that we shouldn't include as we are not claiming equivalence with those devices and say it is only required for state of the art section. I have seen inclusion of similar device in many CERs. If you could answer this with relevant justification, it would be more helpful.
You can include similar devices (which are not equivalent) for several reasons, as listed in the MEDDEV MEDDEV 2.7/1 revision 4, 9.3.2 b).

However, you cannot use similar, non-equivalent device data to demonstrate conformity with ERs.

Quote:
I have seen inclusion of similar device in many CERs.
I've also seen that in several CERs, but the point is that they are wrong. If reviewed under MEDDEV MEDDEV 2.7/1 revision 4, those should not be acceptable.
Thanks to Marcelo Antunes for your informative Post and/or Attachment!
  Post Number #5  
Old 14th March 2018, 12:53 PM
Harini17

 
 
Total Posts: 15
Thumbs up Re: Meaning of Annex II, excluding point Clause 4 conformity

Thank you so much for your clarifications/answers not only this for many of my questions till now. It really helps learners like me, who are in search of answers from the Regulatory standpoint.

Best,
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
Using MDD Annex III + V Conformity Assessment Pathway Sam Lazzara EU Medical Device Regulations 2 29th April 2015 09:46 AM
Meaning of "direct diagnosis" (Annex IX, Rule 10) curzio.basso EU Medical Device Regulations 6 23rd October 2014 03:08 AM
CE Mark Conformity Assessment Annex II vs. Annex VII+ cverg CE Marking (Conformité Européene) / CB Scheme 10 16th January 2014 06:05 PM
Conformity Assesment Review (Annex II) for a New Product - Difficulties pkost EU Medical Device Regulations 5 11th March 2011 05:44 AM
Excluding Clause 8.2.4 as it relates to Cl 7.6 (Control of Measuring Device) qaimari2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8 5th June 2008 12:07 PM



The time now is 05:37 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"