MEDDEV Repair are Multipurpose product 33. Repair tool No No 2.1/1 Apr 94 No and though not an accessory No 1.1g according to MDD. software for hearing aid fitting Software 34. IIa Rule 9 MEDDEV Yes (fitting) 2.4/1 chapter 3.1.4 MEDDEV An integral part of the hearing aid Software 35. IIa Rule 9 2.4/1 No (integrated) chapter 3.1.4 Ref MEDDEV Spare parts for service/repair are not 36. Spare part No No 2.1/1 Apr 94 No medical devices 1.1b Tamperproof An option, and hence an integral part 37. IIa No battery cover of the hearing aid Volume An option, and hence an integral part 38. IIa No control cover of the hearing aid An option, and hence an integral part 39. Wax filter IIa No of the hearing aid. To be seen as a spare part. 40. Receiver in the IIa Rule 9 No No A detachable part that is an integral Ear unit part of the hearing aid 41. APP (That does not Annex IX An APP that has an intended purpose drive or I Rule 12 Yes sec. 1.4 Yes covered by MDD and has no influence the diagnostic purpose and doesn’t device) include a Remote Control function of the hearing aid. 42. APP (that drives or IIa Rule 9 Yes Annex IX, Yes This could be an APP including a 3.2 Remote Control that changes a
33. Repair tool No No No MEDDEV 2.1/1 Apr 94 1.1g No Repair are Multipurpose product and though not an accessory according to MDD. 34. Software (fitting) IIa Rule 9 MEDDEV 2.4/1 chapter 3.1.4 Yes software for hearing aid fitting 35. Software (integrated) IIa Rule 9 MEDDEV 2.4/1 chapter 3.1.4 No An integral part of the hearing aid 36. Spare part No No Ref MEDDEV 2.1/1 Apr 94 1.1b No Spare parts for service/repair are not medical devices 37. Tamperproof battery cover IIa No An option, and hence an integral part of the hearing aid 38. Volume control cover IIa No An option, and hence an integral part of the hearing aid 39. Wax filter IIa No An option, and hence an integral part of the hearing aid. To be seen as a spare part. 40. Receiver in the Ear unit IIa Rule 9 No No A detachable part that is an integral part of the hearing aid 41. APP (That does not drive or influence the device) I Rule 12 Yes Annex IX sec. 1.4 Yes An APP that has an intended purpose covered by MDD and has no diagnostic purpose and doesn’t include a Remote Control function of the hearing aid. 42. APP (that drives or IIa Rule 9 Yes Annex IX, 3.2 Yes This could be an APP including a Remote Control that changes a