cfarrell's blog

Changes to Member State implementation of Directive 93/42/EEC (3) of 14 June 1993 concerning Medical Devices as required by Directive 2007/47/EC

Background

Member States of the European Union recently implemented Directive 2007/47/EEC of September 5th 2007 concerning Medical Devices. This Directive amended Directive 93/42/EEC from June 14th 1993. Given that this Directive should now have become part of the national legislation of each EU Member State, it is a good time to take a look at how the provisions of the Directive could apply to open source software.

I've noticed what seems to be a growing demand on behalf of downstream recipients of open source software to provide a list of all the licenses which can be found in the software provided. Generally, what is meant is a 'license overview' of the various packages in the software and not a comprehensive analysis of all the licenses in the source package.

 

About RPM packages and distributions

What a downstream recipient normally receives and installs is a compiled binary package. In the case of the 'RPM' distributions such as openSUSE, Fedora and Mandriva, this is a binary 'RPM' package (e.g. mypackage-0.1.i586.rpm would refer to a package called 'mypackage' in version 0.1 for a i586 (32bit) architecture).

Regardless of what you might think of Microsoft's Community Promise I'm sure that it will generally be seen as a step forward, that Microsoft yesterday stated that the Community Promise will apply to ECMA 334 and ECMA 335 specifications (this affects C# and the CLI). In the blog entry from Peter Galli, it was pointed out that this means that "Microsoft provides assurance that it will not assert its Necessary Claims against anyone who makes, uses, sells, offers for sale, imports, or distributes any Covered Implementation under any type of development or distribution model, including open-source licensing models such as the LGPL or GPL"

http://port25.technet.com/archive/2009/07/06/the-ecma-c-and-cli-standards.aspx

At the beginning of July this year, we will have had the GPLv3 for two years. At this stage, many of the changes which the GPLv3 brought with it are known, not only to those dealing with FLOSS licenses on a daily basis, but also across the industry as a whole. Quite a lot of the discussion focused on issues such as “Tivo-isation” and the new patent clause – this is obvious from the commentary (and the comment frequency analyser) at http://gplv3.fsf.org/comments/gplv3-draft-4.html as well as from the number of blogs and articles which focused on this issue over the last two years. There is, however, another issue which has been somewhat drowned out by the patent and DRM discussions – that of outsourcing arrangements under the various versions of the GPL.

Recently, I began looking around for a web framework with which to develop a new web application. My requirements were fairly simple – I wanted something which wouldn't cost me much (if anything), which would let me develop in my programming language of choice (Python), my database of choice (PostgreSQL) and which would allow me to modify and distribute the framework itself. Are you beginning to notice a trend here? My basic requirements had already more or less reduced my choices to Free/Open Source Software – not necessarily because I ultimately wanted to save costs, but rather because I wanted to have the freedom to change, not just my own application, but also the framework and development components which I anticipated using to create the application.