CE-marked devices require EN ISO 14971 risk management

[wrodnigg]

Since EN 1441 has been superseded by EN ISO 14971 at 2004-04-01, all manufacturers of medical devices (also active implantable) and in-vitro diagnostics have to update their technical documentation:

From now on a maintained risk management file (acc. EN ISO 14971) is mandatory.

[Dave-h]

Hello Wrodnigg,

Have you produced a risk management file for a medical device under this new standard? Or have you seen one that meets the requirements?

We have just submitted a new device for UL approval. As it contains some control software, they wanted a risk management system in line with ISO 60601-1-4 and ISO 14971. So we put together (in a bit of a rush) what we thought would meet the requirements of both standards - as yet we have not heard back from UL.

I'll let you know when I hear back from them.


Dave

[Bridget]

Hi Dave and wrodnigg:
I am also struggling with this new standard and approach.
If anyone has any info to share it will help.
Bridget

[wrodnigg]

I have a template for a rm-file acc. 14971, but it is in german.

When I find some time, I will translate the important parts and contribute the document here. (At the moment I am working on rm for md-software, maybe next week...)

[DAMAS]

Hi Wrodnigg,

Don't want to put the pressure on however how did you go with the Risk Management Template you had in german. I am new to this and would appreciate any tips on risk managemnet and the file structure etc anyone can offer.

[wrodnigg]

For some examples just refer to the Annex of the standard EN ISO 14971.

There is a new draft version ISO/DIS 14971 from 2006-06-19 containing more annexes with even more examples... (available at iso.ch)

[Valery]

Originally Posted by wrodnigg

I have a template for a rm-file acc. 14971, but it is in german.

When I find some time, I will translate the important parts and contribute the document here. (At the moment I am working on rm for md-software, maybe next week...)

Hi Wrodnigg,

Could you send me a rm-file acc. 14971 in german, if there is no one in english.
Thank you in advance.
Regards, Valery.

[wrodnigg]

A revision of the EN ISO 14971 standard for risk management has been published by 2007-03.

Today a new List of Harmonized Standards has been published, the DOW is March 9, 2010.