K Karichan Starting to get Involved Aug 29, 2014 #1 Aug 29, 2014 #1 Hello May I ask that the Hearing Aids should be classified as Class I or Class II under EU? Thank you
Hello May I ask that the Hearing Aids should be classified as Class I or Class II under EU? Thank you
Gert Sorensen Forum Moderator Moderator Aug 29, 2014 #2 Aug 29, 2014 #2 Class IIa, short term invasive.
G Guillaume Prom Sep 14, 2014 #3 Sep 14, 2014 #3 I'm OK for class IIa, but I think that it's rule #9: active device that administer energy (where sound = energy).
I'm OK for class IIa, but I think that it's rule #9: active device that administer energy (where sound = energy).
C c.mitch Quite Involved in Discussions Sep 14, 2014 #4 Sep 14, 2014 #4 Hi guillaume, Yes. Class IIa according to rule #9. I saw another manufacturer having its products in this class in EU.
Hi guillaume, Yes. Class IIa according to rule #9. I saw another manufacturer having its products in this class in EU.
dgrainger Trusted Sep 17, 2014 #5 Sep 17, 2014 #5 FYI - MEDDEV 2. 4/1 Rev. 9 P39 lists Hearing aids as class IIa. ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm Last edited by a moderator: Sep 17, 2014
FYI - MEDDEV 2. 4/1 Rev. 9 P39 lists Hearing aids as class IIa. ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm
