Healthcare Software Guidelines Following two years’ worth of development, guidelines coveri

Healthcare Software Guidelines

Following two years’ worth of development, guidelines covering qualification and classification of software for healthcareapplications related to medical devices were also released as part of the MDEG meeting; these guidelines address software for the following uses:

• Software used as an active therapeuticmedical device;

• Software for diagnosis or therapy; and

• Software for in-vitro diagnostic devices.

The guidelines address software commonly used in platforms including hospital information systems, telemedicine systems, medical data monitoring systems as well as IVD software—laboratory information systems, work area managers andexpert systems.

According to the guidelines, stand-alone software may be classified either as an active medical device under 93/42/EEC or as an IVD under 98/79/EC.

At the writing of this column, many of the MEDDEVs described above were not published formally.
However, we will certainly provide updates in upcoming months. Beyond these developments, the E.U. Commission has planned meetings for February 6 and 13 focused on revisions to medical device legislation, which should shed more light on how European medical device regulations will change.

We certainly look forward to manyregulatory changes in the European Union in 2012.