European Commission Publishes Guidance on Stand-Alone Medical Software

The much-anticipated (and unbelievably wordy) "MEDDEV 2.1/6: Guidelines on the Qualification and Classification of Stand-Alone Software Used in Healthcare within the Regulatory Framework of Medical Devices" has just been published. Guidance has been sorely needed by industry, as stand-alone software plays an increasingly important role for clinical purposes. As Erik Vollebregt, a Dutch lawyer specialising in the life sciences, remarks: "There is an app for everything these days." How this software meshes with EU medical device regulations that were drafted with embedded or pre-installed software in mind has been a dilemma for manufacturers. This document, although not legally binding, will set some parameters that are expected to be followed within the member states of the European Union.

In a blog post on medtechinsider, Vollebregt takes a first stab at dissecting the document, which is written in that curious eurospeak that sometimes defies comprehension. His overall impression? "It basically provides a frame of reference for stand-alone software under the three medical device directives, which is important for compliance purposes. Many companies don’t know how to comply because they are coming from a software background and are new to medical device regulations."

If that describes you and you market products in the European Union, make it a point to read "MEDDEV Guidelines on Stand-Alone Medical Software."

— Norbert Sparrow