When should the medical device industry show compliance to EN ISO 14971(2007)

B

brentwahl

#1
Team;

After doing a detailed web search (Elsmar ASQ ISO EN CEN IHS) search it is not clear to me when the medical device industry must show compliance to EN ISO 14971(2007) and obsolete any SOP's that list compliance to 14971(2003) 14971(2001).

Thanks in advance

Brent
 
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Marcelo

Inactive Registered Visitor
#2
Re: 14971(2007) When Required

Brent

First some clarifications. International standard bodies such as ISO and IEC publish the standards, but they are not reponsable for compliance enforcement (a standard, in ISO and IEC view, is a recommendation). Legislation, such as the MDD, are the means of requiring compliance to a standard. But, in general, no regulatory medical device scheme asks for compliance to a standard, they focus on the requirement that risks be acceptable (strange enough, Brazil, where i live, is the only one i know where compliance to standards is obligatory). In this "risk management" scheme, standards are simply the easiest method of demonstration that some risks are considered acceptable (the MDD has a list of "harmonized standards" that uses the "presumption of conformity to the essential requirements" approach).

Answering your question: you´ll only have to "comply" to the new edition of ISO 14971 when the legislation in your country updates the standard as a mean of conformance to the requirements.

For example, in the case of Europe, the standard first will have to be published as an EN (european) standard, then it´ll have to be published in the Journal and, consequently, incorporated in the list of harmonized standards.

Even then, there´s always transition period where both old and new versions can be used, and just after that period "compliance" to the new version is required.

Hope that helps.

Cheers.
 
B

brentwahl

#3
Re: 14971(2007) When Required

Thank you for the fast help. :>

Is there a web site that can show the status of EN and Journal listing for such (14971(2007))?

Regards

Brent

Also inside the new standard I have cut and pasted a few points listed below

National foreword

This British Standard was published by BSI. It is the UK implementation of
EN ISO 14971:2007. It supersedes BS EN ISO 14971:2001 which is withdrawn.

This European Standard was approved by CEN on 9 March 2007.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European

Standard the status of a national standard without any alteration.

This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by September 2007, and conflicting national
standards shall be withdrawn at the latest by September 2007.

This document supersedes EN ISO 14971:2000.

Endorsement notice
The text of ISO 14971:2007 has been approved by CEN as EN ISO 14971:2007 without any
modifications.

This second edition cancels and replaces the first edition (ISO 14971:2000) as well as the amendment
ISO 14971:2000/Amd.1:2003.
 
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Marcelo

Inactive Registered Visitor
#4
Re: 14971(2007) When Required

Hello Brent

For a reference to harmonised standards, the url is: http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html

For more information abour the directives, go to http://www.newaproach.org

What you pasted means that there´s already an European Version (European Standard was approved by CEN on 9 March 2007) and a British implementation (which is obrigatory, a national standard or endorsement of the EN).

Regarding the replacement, what it means, from a "standards institution" point of view (and not from a legal point of view, this distinction is important) is that the current version of EN ISO 14971:2007 (in the case of BS EN ISO 14971:2007 and BS EN ISO 14971:2000, both are considered current, and in September 2007 the conflicting standard, BS EN ISO 14971:2000, has to be withdrawn).

But this doesn´t mean that "legally" it can be accepted as a presumption of conformity harmonised standard. It still has to be published in the Official Journal of the European Communities to be considered one.

Surely, you can use the new standard (and i recommend using it, as it has some interesting changes that will help in the implementation) and it certainly will be accepted (as i told you, standards are not compulsory, if you can show that the risk is managed in another way - this means that a new version is generally accepted because it´s considered an aprimoration of the last one).
 
T

temujin

#6
Re: 14971(2007) When Required

(...) (strange enough, Brazil, where i live, is the only one i know where compliance to standards is obligatory). (...)
Does this mean that when exporting to Brazil, a self-declaration for compliance to a e.g. particular standard is not enough?

If compliance to standards is mandatory, where can I find information as to exacly which standards to comply with?

Just for curiosity...

Best regards
t.
 
R

Roland Cooke

#7
Re: When the medical device industry must show compliance to EN ISO 14971(2007)

Compliance to standards can be mandatory if the national authority / legislation specifically requires it. I'm not aware of any countries that have specifically listed this standard.

Beyond that, auditors on behalf of the regulatory authorities can expect to see it. This will include FDA and Notified Body auditors. For example, even though the QSRs only make reference to "risk analysis" I believe the FDA auditors will be looking for an integrated risk management system.

Whilst there are some significant changes in ISO14971:2007, the issues my auditors and I still frequently come across tend to revolve around failure to comply to the intent of the original version, let alone the new one.

Failure to integrate risk management as a formalised processs across all of product realisation (as well as links to Analysis of Data and Management Responsibility/Review etc) is still a major issue.


From March(?) 2010, the 2000 version will no longer be valid, so from an SGS perspective we will be raising OFIs in 2008/2009 and non-conformities from 2009/2010* for a failure to implement the requirements of ISO14971:2007.

(*NCs could be raised "early" against failure to plan etc)
 

Marcelo

Inactive Registered Visitor
#8
Re: When the medical device industry must show compliance to EN ISO 14971(2007)

Hello Temujin

Does this mean that when exporting to Brazil, a self-declaration for compliance to a e.g. particular standard is not enough?

If compliance to standards is mandatory, where can I find information as to exacly which standards to comply with?
Brazil has a little weird regulatory requirement system. The majority of the regulation ia a copy from the MDD, but we algo have a GMP system which is copied from the FDA. And, even worse, regulatory authorities do not know very well what they´re doing (this is my opinion :))

Any way, another weird aspect is that Brazil has a conformity assessment scheme that is applicable just to some products. Although the new legislation on the subject (RDC 32 - 2007) has been extended to cover all electrical equipment under sanitary vigilance, in fact only equipment which has:

1 - a brazilian version (ABNR NBR) of a particular IEC 60601-2-X standard (for ex, ABNT NBR IEC 60601-2-5 on therapeutic ultrasound equipment)

2 - a accreditated laboratory (by inmetro) which can perform the tests.

is required to go thru the certification process. There´s a normative instruction (IN) which has a list of these standards.

As you can see from the list, only 27 types of equipment, and they´re all medical electrical equipment, are subject to the conformity assessment procedures.

And a self0delcaration of compliance to the stadards is, by said procedures, not enough. You can use laboratories from abroad, but they have to be Ilac-traceable, and also for this rout you have to use a certification or notified body which has a MOU with a brazilian certification body.

The process obviously is more complex than that, but i hope i could shed some light into it.

Cheers!
 
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