The MDEG (the European Commissions’ Medical Devices Expert Group) working group for borderline and classification, decided in September 2009 to create a new working group to handle issues regarding Medical Information Systems and how they relate to the three medical device directives (MDD, AIMDD and IVDD). Since its creation and until June 2010, the new working group for Qualification and Classification of Medical Information Systems has had three meetings.
This new working group will only be handling issues of qualification and classification, although they have identified important issues that will fall outside the scope of their mandate, i.e. relevant harmonized standards and the possible need for quality management systems for MDD class I manufacturers. These issues will not be formally reported but documented for possible use in the future. At the moment, the working group is editing a document that will serve as the foundation of their work.