New European MEDDEV Guidance on Stand-Alone Software

On July 15, 2016, the European Commission published a new version of its medical devices guidance, known as MEDDEV, on the qualification and classification of stand-alone software when used in a healthcare setting. It is commercially important to establish the legal status of a software when used in this context, for example, a mobile application intended as an aid to improve wellness. In particular, given the legal definitions in Directive 93/42/EEC, the software may be regulated as a medical device.

Classification of software has been controversial and subject to interpretation by the regulatory authorities. As discussed in our Advisory, whilst the revised MEDDEV seeks to clarify this borderline and assist software developers in identifying the applicable regulatory framework, the underlying principles of the guidance remain unchanged. The main update is the addition of new definitions. The guidance defines "software" as a set of instructions that processes "input data" and creates "output data." The decision tree in the guidance, used to help determine whether software will be classified as a medical device, has been updated to reflect these new definitions, but the substance is unchanged.

The guiding principles in the revised guidance apply equally to mobile apps. However, the guidance does not contain any specific information on apps. As set out in a previous post, the Commission is currently preparing guidelines on mobile health apps that are not classified as medical devices. Therefore, the updated MEDDEV guidance should be read in conjunction with other relevant guidance issued by the Commission to inform the correct classification of apps and guide product development.