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Greetings, Is anyone aware of a future European Directive related to Research Use Only (RUO) instruments? At times, it has been a borderline issue if a device is a RUO instrument or an IVD instrument. Can anyone provide the location of some guidance documents that help clarify this issue? I have the following documents from the European Commission, MEDDEV 2.14/1 and MEDDEV 2.14/2, however, I would like any additional guidance I can obtain. Your assistance is appreciated. Joe Martin Applied Biosystems This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. IEEE PSES Main Website: http://www.ieee-pses.org/ To post a message send your e-mail to [email protected] Instructions for use of the list server: http://listserv.ieee.org/listserv/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
