Systems Requirements Mandated by EN46001 and EN46002

[Marc]

Subject: Re: Q: EN46000 /Andrews/Meron
Date: Mon, 8 Nov 1999 16:35:12 -0600

From: Emanuel Meron

> Subject: Q: EN46000 /Andrews
> From:
>
> Respected List Members,
> Can anyone direct me to more information on the system requirements
> mandated by EN46000?
>
> Any and all information is most appreciated.
>
> Thanks,
>
> Ethan Andrews

EN46001 and EN46002 are not stand alone standards. They give additional requirements for the application of ISO9001 and ISO9002 to the medical device industry. To really understand the requirements you must read EN46001 together with ISO9001, and EN46002 together with ISO9002. A system in compliance with those standards is a prerequisite for CE marking a medical device in accordance with the European Medical Device Directive 93/34/EEC (MDD). Such a system will be similar, though not identical, to one complying with FDA's QSR (Quality System Regulation) 21 CFR 820.

Emanuel Meron

[Marc]

Subject: Re: Q: EN46000 /Andrews/Moore
Date: Mon, 8 Nov 1999 16:55:27 -0600

<< Ethan >>

En46000 is substantially equivalent to ISO 9000 requirements but it also includes special additional requirements that make it a standard specifically for medical device manufacturers.

EN 46001 is substantially equivalent to ISO 9001 + the medical device specific requirements, which make both of the standards substantially equivalent to the new US FDA QSR (Quality System Requirments (and ISO 13485). There are small differences between all of these standards, but they are all substantially the same.

Confused? Well so are the regulators! This year there was talk at the global harmonization task force meeting in Bethesda, Maryland of Europe phasing out EN 46001 and start using ISO !3485.

But since ISO 13485 is based on ISO 9001 which is being changed to include continuous improvement and customer satisfaction, the regulators have indicated that they have second thoughts on how to proceed, as they do not want to get involved in these two areas.

So once you obtain a copy of EN 46001 or EN 46002, make sure your registrar has the capability to support ISO 13485 (and ISO 13488) as this is what you will need when EN 46001/2 is phased out in a few years. Hopefully the regulators will have their thoughts ironed out soon as to where and how they want to draw the line of regulatory responsibility with the newly revised standards.

As for a copy of the EN 46000 standards, any registrar that tells you they can audit to them can help you obtain a copy or any Notificed Body for the CE Mark can also help you. These are organizations like BSI, AFAQ, TUV (http://www.tuvglobal.com), and others.

Regards,

JackTQM

[Marc]

Subject: Re: Q: EN46000 /Andrews/Mackenzie
Date: Mon, 8 Nov 1999 16:57:33 -0600
From: Moderator <jennejohnn@UWSTOUT.EDU>

From: "J. H. MACKENZIE" <jim_mackenzie@compuserve.com>

There are 3 guidance standards you may want to refer to:

EN724 for non active devices

EN50103 for active devices

EN928 For in vitro diagnostics

Regards,

Jim Mackenzie

[Marc]

Subject: Re: Correction to Q: EN46000 /Andrews/Meron/Meron
Date: Tue, 9 Nov 1999 15:49:03 -0600
From: Moderator <jennejohnn@UWSTOUT.EDU>

From: Emanuel Meron <ms_comp@netvision.net.il>

> EN46001 and EN46002 are not stand alone standards. They give additional
> requirements for the application of ISO9001 and ISO9002 to the medical
> device industry. To really understand the requirements you must read
> EN46001 together with ISO9001, and EN46002 together with ISO9002. A
> system in compliance with those standards is a prerequisite for CE marking
> a medical device in accordance with the European Medical Device Directive
> 93/34/EEC (MDD). Such a system will be similar, though not identical, to
> one complying with FDA's QSR (Quality System Regulation) 21 CFR 820.
>
> Emanuel Meron

The correct number of the MDD is 93/42/EEC. Sorry for the typo.

Emanuel Meron

[Marc]

Subject: Re: Correction to Q: EN46000 /../Meron/Meron/Lazzara
Date: Tue, 9 Nov 1999 16:38:45 -0600
From: Moderator <jennejohnn@UWSTOUT.EDU>

From: Sam Lazzara <slazzara@corvascular.com>

On small correction: A system in compliance with EN 46001 or EN 46001 is not required to apply the CE marking. There are alternative conformity assessment pathways that do not necessitate compliance with these standards. I believe that it is true, however, that most companies take the "Full QA System" approach (Annex II of the Medical Device Directive).

Sam Lazzara