Here is some follow up on the previous Blue Guide post: the new version of the Blue Guide is the first to address software updates to CE marked products, including software. For the purpose of this blog this would typically be standalone software that constitutes a medical device in the meaning of MEDDEV 2.1/6.

Harmonised standards

When standalone software that constitutes a medical device is updated, patched or has its functionality expanded with a plug-in or add-on, the same rules apply as to a normal medical device that it is serviced during its lifetime, except that the EU harmonized standard for medical devices software EN 62304 has a few processes to add that are relevant to updates, patches, plug-ins and add-ons. These processes are explained up to a point in the helpful EN 62304 FAQ.

New requirements in MDR and IVDR

The proposed new medical devices and IVD regulations have some new additional clauses with respect to repairs and replacement parts that would also apply to standalone software as medical device, even though they are written for widgets, which is one of the flaws of the proposals. They are supposed to modernize EU medical devices law for decades to come, but fail to account adequately for the development of standalone software medical devices.

So….

Why such a brief post – you are used to a lot more detail from me normally, right?

Well, that’s because this post is a summary of the article I wrote in the legal and regulatory journal eHealth Law & Policy, which the publisher kindly permits me to put on my blog and you can download it here. I warmly recommend the journal if you want to stay in touch with legal and regulatory developments in eHealth and mHealth.

I have just written an article on unannounced audits by notified bodies specifically with manufacturers of standalone software medical devices in mind, so if you’re curious, take a look.