MDD (Medical Device Directive) Essential Requirements Checklist

W

Watchwait

#1
Does anyone have a completed example of an MDD Essential Requirements checklist? I have the blank checklist in *many* very similar formats, but none with any content. For example, the "General Requirements" section looks like it might require information very similar to information requested in subsequent sections of the ER checklist. Quite confusing & I'm hoping someone can share their experience in this regard...
 
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Marcelo

Inactive Registered Visitor
#2
Re: MDD Essential Requirements Checklist - Complete?

What exactly are you talking about? The checklist which is similat to the one given in "ISO/TR 16142:2006 - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices"? (by the way, this TR has a somewhat "complete" checklist in which it shows the best standards used to fulfill the different essential requirements...just bear in mind that it´s not enough as it´s a general view for general medical devices...)
 
A

Adele

#3
Re: MDD Essential Requirements Checklist - Complete?

As mmantunes mentioned - ISO TR 16142 is a good example of what standards to use where. However, it is very top-level and it is up to you to determine what other compliance methods you are going to use to meet the Essential Principles.

The Medical Device Control Office in Hong Kong have the following example on their website - http://www.mdco.gov.hk/english/emp/...al_principles_conformity_checklist_md_ccl.pdf.

Is this what you are after?
 
W

Watchwait

#4
Re: MDD Essential Requirements Checklist - Complete?

Wow! This example is worth a thousand words!! This is EXACTLY what I've been looking for to use as a model. Thank you Hong Kong!!:thanx:
 
R

Roland Cooke

#5
Re: MDD Essential Requirements Checklist - Complete?

I have to say I've really gone off these checklists.

To take the MDD for example, there is no requirement to have such a checklist. There is only the need to demonstrate that you have met all the applicable requirements.

By having something so non-descriptive you run the very real risk of not answering the questions. Is there really a definitive answer to the requirement in the probably-general report you have referenced, or are you just assuming that?


In addition you should make a clear case for why an individual requirement is not applicable. (Usually it's obvious, but not always). Simply putting "N/A" is often a non-conformity in my experience.


As it happens, the attached example is one of the better ones I come across, principally because compliance can be demonstrated by testing against established international standards. Typically that won't be the case.


I would strongly advocate making a detailed textual answer to each point, then backing it up by reference to data located elsewhere.
 
A

Adele

#6
Re: MDD Essential Requirements Checklist - Complete?

Roland is right - it is very easy to simply use this as a checklist and not really gain any benefit from it. We use the Essential Requirements as an input to our design. An Essential Requirement that is identified as being applicable is carried over to another document and the method we have used to actually meet the Essential Requirement and the supporting documentation is referenced in that.
 

Marcelo

Inactive Registered Visitor
#7
Re: MDD Essential Requirements Checklist - Complete?

In fact, these kind of checklists are, in my opinion, misleading and one of the reasons why risk management is taken at a so high-level and in this way not correct. People think that, because the MDD requires that the "electrical shock" hazard has an acceptable risk, you only need to look into that in general, when in fact you must see all the hazardous situations that can produce an electrical shock. They do not understand that it´s a veryyyyy general and high level requirement as is written in the MDD. And if you use standards as means of demonstrating compliance, you also have to put all the used standard requirements (which are risk controls in the risk management process) in your risk management file, so it would be just more work to compile such a simplistic checklist.
 
5

58431Check

#8
Re: MDD Essential Requirements Checklist - Complete?

Hi. Can I borrow a copy of this standard or is there a free version out there?

Thanks, Lee
 
5

58431Check

#9
Re: MDD Essential Requirements Checklist - Complete?

I'm looking for the same this only with the standards and applicable sections for Class IIb Medical Devices Annex V. It's asking a lot, I know, but all my consultant is doing is spending my money and we are getting nowhere in a big hurry and I'm going to have my head handed to me soon. Can anyone out there help?
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#10
Re: MDD Essential Requirements Checklist - Complete?

Hi. Can I borrow a copy of this standard or is there a free version out there?
Please don't ask to "share" or "borrow a copy of" standards here. Standards are copyrighted documents. My only comment in that respect is "Google".
 
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