New guide for manufacturers of standalone software
Tuesday, June 12, 2012
The European Commission has adopted a guide for manufacturers of standalone software that describes the criteria for whether a product is considered a medical device and thus should be CE-marked. In this article, the MPA provides an introduction to the guide. In addition, work has now begun to update the 2009 Swedish guide on Medical Information Systems.
As a general rule of thumb, the system must be CE-marked if the manufacturer has described it as having a medical purpose. A user should then expect the manufacturer to have taken into account patient risk and patient benefit when designing the system. If a system is not described as a medical device, but only in technical / administrative terms, one can not automatically assume that the manufacturer has dealt with the patient safety aspects.
Safety comes first and in individual cases the availability of a product may be of more benefit to patients than a market suspension for formal reasons. Therefore, in specific cases and if necessary, manufacturers may be granted a limited period to make adjustments after submitting an appropriate and acceptable risk assessment.
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 Introduction to the document MEDDEV 2.1 / 6 Guidelines.