acoustic output) Multipurpose product and though not MEDDEV an accessory according to MDD Charger 11. No 2.1/1 Apr 94 No (for rechargeable No No batteries) 1.1g Manufacturers can decide to classify as MD or not. If classified as MD following rationale should be used. Charger If MD then (designed for If MD then If MD then MEDDEV 12 Yes Battery chargers specifically intended charging hearing I Rule I+12 2.1/1 Apr 94 for recharging hearing aid batteries aids including 1.2 battery) are non-invasive and are active devices because they act by converting energy. Cleaning fluid is a medical device, but invasive. only if specifically developed to clean Cleaning fluid Rules 2,3,4 hearing aids etc. (not disinfecting, to 13.1 I Rule I does not Yes clean hearing aids/earmoulds by apply. the user) Cleaning fluids (that have Specific cleaning fluids for disinfection MEDDEV disinfecting 13.2 IIb Rule 15 2.4/1 June Yes function to 2012 Rev 9 disinfect hearing aids/earmoulds by the user)
acoustic output) 11. Charger (for rechargeable batteries) No No No MEDDEV 2.1/1 Apr 94 1.1g No Multipurpose product and though not an accessory according to MDD 12 Charger (designed for charging hearing aids including battery) If MD then I If MD then Rule I+12 If MD then MEDDEV 2.1/1 Apr 94 1.2 Yes Manufacturers can decide to classify as MD or not. If classified as MD following rationale should be used. Battery chargers specifically intended for recharging hearing aid batteries are non-invasive and are active devices because they act by converting energy. 13.1 Cleaning fluid (not disinfecting, to clean hearing aids/earmoulds by the user) I Rule I Rules 2,3,4 does not apply. Yes Cleaning fluid is a medical device, but only if specifically developed to clean hearing aids etc. 13.2 Cleaning fluids (that have disinfecting function to disinfect hearing aids/earmoulds by the user) IIb Rule 15 MEDDEV 2.4/1 June 2012 Rev 9 Yes Specific cleaning fluids for disinfection invasive.
Classification-Document-v14.4.docx