On 15 July 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 applicable legal definitions, the software may be susceptible to regulation as a medical device. Classification of software has been controversial and subject to interpretation by the regulatory authorities. 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.

Background: medical devices and software

Under the EU legislation, a software may be considered as a medical device according to the definition set out in Article 1(2) of Directive 93/42/EEC. The case law of the Court of Justice of the European Union on classification of borderline products states that a case-by-case assessment is needed, taking account of the product characteristics, the underlying properties, and the intended use. These parameters help establish whether the product has a medical purpose, meaning it is capable of appreciably restoring, correcting, or modifying physiological functions in human beings. However, in relation to classification of software, it is not immediately apparent how these parameters would apply in order to determine whether the software has a medical purpose, given that software products generally do not have physical contact with the body to restore, correct, or modify the bodily functions.

The European Commission's published guidelines on the interpretation of the medical devices Directives (the MEDDEV guidance) has been treated as a useful tool to assist in interpreting the legal requirements. MEDDEV 2.1/1 sets out guidance on definitions, including software; MEDDEV 2.1/6 addresses the Commission's views on the classification and regulation of software, and it is this module that has recently been updated.

Key points in the revised MEDDEV guidance

  • The updated guidance adds new definitions to assist software developers. The guidance defines "software" as a set of instructions that processes "input data" and creates "output data". Input data is any data provided to software in order to obtain output data after computation of those data (for example, through a keyboard or speech recognition software). Output data is any data produced by a software (for example, on-screen display). The decision tree in the guidance, used to help determine whether stand-alone software will be classified as a medical device, has been updated to reflect these new definitions, but the substance is unchanged.
  • Software used in a healthcare setting is not necessarily a medical device. The guidance distinguishes between software provided as a diagnostic or therapeutic tool, and software used to handle general patient related data. This distinction is maintained in the updated guidance, and the key factor is whether the software applies a tool for combining medical knowledge with patient-specific information. Only diagnostic or therapeutic tools serving a medical purposes are considered to be medical devices. For this reason, software that calculate anatomical sites of the body and image enhancement software intended for diagnostic purposes, for example, are software medical devices because they perform a particular function, over and above the healthcare professionals' clinical judgment, in order to assist with clinical diagnosis and treatment. In contrast, a software used for administration of general patient data is not a medical device because there is no medical purpose. Similarly, information systems intended only to store, archive and transfer data, and programmes that alter patient data for embellishment purposes, do not render the software a medical device.
  • The guiding principles set out in the revised guidance apply equally to mobile applications for the purposes of legal classification. However, the guidance does not contain any specific information on mobile apps. As set out in a previous Advisory, the Commission is currently preparing guidelines on mobile health apps that are not classified as medical devices. Therefore, the MEDDEV guidance should be read in conjunction with other relevant guidance issued by the Commission to inform the correct classification of a mobile application, especially in respect of its performance and functionality, in order to guide research and development.