Standards for Electronic Labeling of Medical Devices

Have any (non-FDA) standards been published yet for electronic labelling of medical devices?

Re: Standards for Electronic Labelling of Medical Devices

Not as far as I know. I'm aware of a group in the EU working on an e-labelling protocol for IVD's. It is expected that this will some day be extended for Medical devices.

Re: Standards for Electronic Labelling of Medical Devices

EU already released guidance document for e-labeling MEDDEV 2.14/3 REV 1 released on January 2007 permits IVD companies whose products are intended for PROFESSIONAL USE ONLY to provide their Instructions for Use (IFU) on different media such as CD, internet, fax, etc. in addition to the traditional paper format. But not released e-labeling guidance document for MDD so far.

Attached is MEDDEV 2.14/3 REV 1, IVD GUIDANCES: Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD) Medical Devices.

Thanks and Regards
S. Subramaniam

thank you very much for this Subbu. our sister company has just started a project to implement this guideline. but i guess we wont be able to use this in the US.

Annex B of the harmonized standard EN 1041:2008 covers the topic of electronic instructions for use of medical devices (within the EU).

Roland Cooke said:

Have any (non-FDA) standards been published yet for electronic labelling of medical devices?

Click to expand...

Hi,

Try to search EN980:2008, hope it could help you!

As far as Medical Devices are concerned there is a draft directive circulating and comments were due 15 September. The Commission, Industry, and Member States have not been able to agree on it however. Potentially after new draft is circulated finalization will happen early 2011.

The European Commission has recently published a draft Regulation on electronic instructions for use for medical devices.

http://click.bsi-global-email.com/?...1077e76&s=fe33167676640774771572&jb=ffcf14&t=

Does anyone have a copy of the inspection checklist (from BSI or other) for inspecting to the new EU e-Labeling Directive Requirements and/or a risk assessment for the introduction of e-Labeling?