Information regarding the exemption application
The 18 Juni 2012 MPA has concluded that allowing parallel sales of packs of old and new label for a maximum of 6 months, regarding MAH transfers / Agent changes. (Source: MPA RSS news -)
Source: MPA RSS news - - June 19, 2012 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: news
New guide for manufacturers of standalone software
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. (Source: MPA RSS news -)
Source: MPA RSS news - - June 12, 2012 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: news
Position of the MPA regarding Lucentis and Avastin
Lucentis (ranibizumab) is approved for the treatment of neovascular age related macular degeneration (AMD), for the treatment of visual impairment due to diabetic macular oedema (DME) and retinal vein occlusions (RVO). (Source: MPA RSS news -)
Source: MPA RSS news - - March 16, 2012 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: news
Changes in procedure for requesting Sweden as RMS in DCP
The Swedish Medical Products Agency participates actively in the decentralised procedure as reference member state (RMS) and has since the start received a high number of requests for time slots. (Source: MPA RSS news -)
Source: MPA RSS news - - March 12, 2012 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: news
Nyheter-2012
(Source: MPA RSS news -)
Source: MPA RSS news - - February 2, 2012 Category: Medical Equipment Authors: Medical Products Agency, Sweden Source Type: news
