New Guide for Manufacturers of Stand Alone Software

On June 12, 2012 the Medical Products Agency (Swedish Authority) published an introduction to the so called MEDDEV 2.1/6 Guidelines. The MEDDEV 2.1/6 Guidelines were published by the European Commission DG Health and Consumer in January 2012. The title is "GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES".

The MEDDEV 2.1/6 Guidelines have been developed to provide the following information:

  • Introduction of qualification criteria in addition to those provided in the definition of a medical device 
  • What functions can be considered to have a "medical purpose"?
  • How to distinguish between software subject to the regulatory framework for in vitro diagnostic devices (IVD), 98/79/EC and for general medical devices (MDD) 93/42/EEC
  • Software available via the Internet 
  • Appropriate level of division of systems into modules 
  • Development of appropriate product examples

The new Introduction to MEDDEV 2.1/6 Guidelines published by the Swedish Authority are supposed to provide further explanation. The MPA writes in a press release: "The guidelines developed by the European Commission are in the form of a so-called MEDDEV and are based on the guide that was developed in Sweden in 2009. The document, designated MEDDEV 2.1 / 6, has however a more limited purpose as it is merely directed at manufacturers. It is also important to note that the use of sophisticated medical information systems differs significantly between the European Union’s member states. Some sections, especially the examples, therefore need to be clarified so that they reflect and describe the systems currently on the market.

The MPA has therefore now launched a project to update the Swedish guide. A working group with representatives of the National Board of Health and Welfare, the Swedish Association of Local Authorities and Regions (Health, IT and MT operations), Swedish Medtech / Labtech, Intertek and the Swedish Standards Institute will participate in the project. The reason for the need to update the guide is described in the Introduction to the document MEDDEV 2.1 / 6 Guidelines."

Source: MPA Press Release

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