On 15 July 2016, the European Commission issued a revised version of MEDDEV 2.1/6 entitled “Guidelines on the qualification and classification of stand alone software used in healthcare within the regulatory framework of medical devices“. This new document is intended to replace the original version of MEDDEV 2.1/6 which was issued in January 2012. The revisions to the original document introduced by the new MEDDEV 2.1/6 are, however, fairly limited.

The principal and almost only novel element in the revised version of the MEDDEV 2.1/6 appears in Section 1 of the document concerning definitions.

The document now includes a definition of software which is a:

set of instructions that processes input data and creates output data“.

The MEDDEV also introduces definitions of “input data” and “output data” to enable manufacturers to understand this new definition.

Input data is defined as:

any data provided to software in order to obtain output data after computation of this data“.

The MEDDEV provides a number of examples of input data. These include:

  • Data given through the use of a human data-input device such as a keyboard, mouse, stylus, or touch screen;
  • Data given through speech recognition;
  • Digital document: formatted for general purpose such as Word file or pdf file or jpeg image, formatted for medical purpose such as DICOM file or ECG records or Electronic Health Record, unformatted document. Note that digital documents have to be differentiated from software able to read such documents;
  • Data received from / transmitted by devices.

Output data is defined as:

any data produced by a software“.

Examples of output data provided in the revised MEDDEV 2.1/6 include:

  • Screen display data (such as layout with number, characters, picture, graphics etc.);
  • Print data (such as layout with number, characters, picture, graphics etc.);
  • Audio data;
  • Digital document (formatted for a general purpose such as Word file or pdf file or jpeg image, or formatted for medical purpose such as DICOM file or ECG records or Electronic Health Record, unformatted document);
  • Haptic buzzing as an alternative to audio sound Mobile applications.

This new definition of software also affects the decision diagram included in MEDDEV 2.1/6 which is intended to assist manufacturers in determining the qualification of software as medical device. The first question in the diagram was previously “Is the software a computer program?” This is now replaced with the question “Is the product a software?”

In addition to the definition of software, the revised MEDDEV includes a definition of the term “Software as a Medical Device”. This is defined as:

software intended to be used for one or more medical purposes without being part of a hardware medical device“.

This new definition strictly reflects the definition of software found in the International Medical Device Regulators Forum (IMDRF) guidance WG/N10FINAL:2013: “Software as a Medical Device (SaMD): Key Definitions”.

Mobile applications

As the publication of this revised version of the MEDDEV 2.1/6 was anticipated, there were some hopes that the revised document would provide additional guidance and examples concerning mobile apps which fall within the classification of a medical device. Unfortunately, the revised MEDDEV is almost silent on mobile apps. The only revision in this respect in comparison with the previous version of the document can be found in the introduction where it is clarified that “the criteria specified in the document also apply to mobile application“.

The new version of MEDDEV 2.1/6 replaces the previous version of the document with immediate effect.