What Standards can be used for Clinical Evaluation besides ISO 14155?

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dblnkl

#1
What are the recognized standards for clinical evaluation of medical devices?

I am aware of ISO 14155. Are there any beyond that?
 
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pkost

Trusted Information Resource
#2
Hi dblnkl,

Are you referring to clinical evaluation, clinical investigation?

The EU perspective is that an investigation involves the manufacturer carrying out a clinical trial. Guidance for this as you said can be found in ISO 14155.

A clinical evaluation however is a review of all current literature to support your claims of compliance against the essential requirements. It includes things like peer reviewed articles, competitors products, PMS/complaints etc. ISO 14155 isn't really applicable to this; instead you can look at MEDDEV 2.7/4 available here:

MEDDEVs: http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines/

clinical evaluation meddev: http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_7_4_en.pdf
 
S

SteveK

#3
What are the recognized standards for clinical evaluation of medical devices?

I am aware of ISO 14155. Are there any beyond that?
Hi dblnkl,

I agree fully with pkost - however if you have not already found these you can also check out:

ghtf.org/ sg5/ sg5-final.html

and what notified bodies have to check for i.e. their checklist - NBOG CL 2010-1: (EDIT: DEAD LINK DEACTIVATED.)

http:// www. nbog.eu /2.html (EDIT: DEAD LINK DEACTIVATED.)

They could be of use or give you some more perspective.

Steve

EDIT: DEAD LINKS DEACTIVATED.
 
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D

dblnkl

#4
Thank you both very much. You have directed me to some useful documents. I believe that all these documents would be classified as guidances. To take my situation a bit further, I am assembling a list of standards for the design, manufacturing, evaluation of an AIMD. AAMI, ANSI, IEC, ISO, MIL, UL, etc. all have standards that would go into this list. However, the only document that I can find that would classify as a standard for clinical evaluation is ISO 14155, which is in fact titled "International Standard." Although the documents to which you have directed me are relevant to the clinical evaluation task, I don't think they qualify as standards in the strict sense. Can you think of any other documents that would fit the "standard" classification?
 
S

SteveK

#5
Thank you both very much. You have directed me to some useful documents. I believe that all these documents would be classified as guidances. To take my situation a bit further, I am assembling a list of standards for the design, manufacturing, evaluation of an AIMD. AAMI, ANSI, IEC, ISO, MIL, UL, etc. all have standards that would go into this list. However, the only document that I can find that would classify as a standard for clinical evaluation is ISO 14155, which is in fact titled "International Standard." Although the documents to which you have directed me are relevant to the clinical evaluation task, I don't think they qualify as standards in the strict sense. Can you think of any other documents that would fit the "standard" classification?
Hi dblnkl,

There is only ISO 14155 “Clinical investigations of medical devices for human subjects” I am aware of as a standard i.e. specific for clinical trails and all that can involve. Because ‘clinical evaluation’ overall is a more nebulas term, that is why I believe you will only find guidelines etc. The way specific devices are evaluated will be in standards of course - but these will be 'bench top' tests.

Steve
 

Michael Malis

Quite Involved in Discussions
#6
What about Clinical and Laboratory Standards Institute (CLSI) guidelines such as HS1-A2 and GP26-A3?

Or your interest is only related to medical device standards?
 
D

dblnkl

#7
Thanks again, Gentlemen. Indeed, this is for a medical device (an AIMD) so lab standards don't apply. My impression is that 14155 is the only one so that seems to be confirmed.

Interesting bit of side news, posted by AdvaMed Smartbrief early this week:
"Satisfying the requirements of the international standard on clinical investigations for medical technology products, also known as ISO 14155, can't be used by device makers as proof that they have complied with the European medical device directives because the standard hasn't yet been integrated with the directives. The European Commission raised a formal objection on several standards earlier this year, which resulted in a moratorium on the harmonization of ISO 14155 with the directives, said an expert with the European Committee for Standardization."
 

renenatasha

Involved In Discussions
#8
Guys, thanks for the info but I don't think that's a conclusion to this post as I'm currently facing the same dead-end as dblnkl.

I'm in the midst of updating the Essential Requirements Checklist for my Technical File but I'm stuck in 6a Demonstration of conformity with the essential requirements must include a clinical evaluation on accordance with Annex X, especially the section where I need to include "Medical Device Standards applied by manufacturer". Other than EN ISO 14155 - applicable ONLY for Clinical Investigation but not relevant to Clinical Evaluation; I'd like to know if there's any Standards pertaining to Clinical Evaluation instead, which include Literature Review. The guideline such as MEDDEV 2.7.1 goes under "Other standards or procedures applied by manufacturer" together with our internal SOP for now.


Could someone please shed a light to this? Is there any harmonized standard(s) for Clinical Evaluation via Literature Review?


Thanks in advance. - Rene
 
S

SteveK

#10
Hi Rene,

As indicated, there are no harmonised standards specifically for clinical evaluation/literature review However to reiterate (and not wishing to sound like teaching Grandma to suck eggs), a medical device needs to be evaluated against relevant standards to show overall compliance e.g. for medical electrical equipment – EN 60601-1 (covering safety), IEC 60601-1-2 etc. Then there is EN 980:2008 for Symbols used, ISO 14971 for Risk and EN 62366 for Usability. Compliance with these would therefore encompass meeting various clinical evaluation related requirements. Then there are the specific standards for devices e.g. ISO 8359:2009 for Oxygen Concentrators – covering safety, and therefore again clinical evaluation requirements (is not safety evaluation a function of clinical evaluation?). I reference all such standards in my ERs. Note as well as the MEDDEV referenced there is also NB-MED/2.7/Rec3 for guidance.

Steve
 
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