Common technical specifications (CTS) for in vitro diagnostic medical devices
The common technical specifications for in vitro diagnostic medical devices (IVDMD), as amended by EC decision n. 9464/2009, were published on the Italian OJ n.123 of May 28th 2010.
The specifications are listed in Annex I of the Ministry bulletin. The CTS concern all the IVDMD listed in Annex II, List A, of D.Lgs. 8 September 2000, no.332, as amended by D.Lgs. 25 January 2010 (implementation of the EU Dir. 98/79/CE and further amendments).
Other than on the OJ, the full text of the bulletin is available on the website of the Ministry of Health, on the Normativa Sanitaria page (http://www.normativasanitaria.it).