5. Classification of Hearing Aids according to MDD 93/42/EEC No. Product Classification Rule Accessory Rationale for Product to Comment according to to According to classification carry CE– 93/42/EEC 93/42/EEC MEDDEV mark acc to Annex IX and Annex IX 2.1/1 Apr 94 93/42/EEC? MEDDEV Yes/No 2.4/1 Rev 9 Tubing is a detachable part that may Acoustical affect the acoustical properties of tubing earmoulds, and the hearing aids. 1.1 IIa (for earmoulds, Tubing is part of a custom earmould, Rule 9 No No supplied with and has gone through conformity earmould) assessment of the hearing aid. Tubing supplied separately can be classified and CE-marked separately Acoustical after a separate conformity tubing MEDDEV assessment if tubing can be used with Yes (if too 1.2 I (for earmoulds or 2.1/1 Apr 94 type of hearing aid. small CE on “any” (Chapter 3.2) Rule 1 domes, supplied 1.2 If shipped in bulk no CE-mark is accompanying separately) document) needed. It is considered as a raw material. Examples are FM equipment, IR equipment, teleloop systems, radio, TV. Depending on the intended use, ALD Depends on MEDDEV ALDs can be accessories to medical 2. Yes/No Yes (assistive intended use 2.1/1 Apr 94 devices or not. listening device) 1.2 Audio shoe specifically designed for a Shoe 3.1 9 defined hearing aid model (If supplied with No hearing Aid)
5. Classification of Hearing Aids according to MDD 93/42/EEC No. Product Classification according to 93/42/EEC Annex IX and MEDDEV 2.4/1 Rev 9 Rule to 93/42/EEC Annex IX Accessory According to MEDDEV 2.1/1 Apr 94 Rationale for classification Product to carry CE– mark acc to 93/42/EEC? Yes/No Comment 1.1 Acoustical tubing (for earmoulds, supplied with earmould) IIa Rule 9 No No Tubing is a detachable part that may affect the acoustical properties of earmoulds, and the hearing aids. Tubing is part of a custom earmould, and has gone through conformity assessment of the hearing aid. 1.2 Acoustical tubing (for earmoulds or domes, supplied separately) I (Chapter 3.2) Rule 1 MEDDEV 2.1/1 Apr 94 1.2 Yes (if too small CE on accompanying document) Tubing supplied separately can be classified and CE-marked separately after a separate conformity assessment if tubing can be used with “any” type of hearing aid. If shipped in bulk no CE-mark is needed. It is considered as a raw material. 2. ALD (assistive listening device) Depends on intended use Yes/No MEDDEV 2.1/1 Apr 94 1.2 Yes Examples are FM equipment, IR equipment, teleloop systems, radio, TV. Depending on the intended use, ALDs can be accessories to medical devices or not. 3.1 Shoe (If supplied with hearing Aid) 9 No Audio shoe specifically designed for a defined hearing aid model
Classification-Document-v14.4.docx