医療機器指令 93/42/EEC の概要(第2版)

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1 93/42/EEC ( 2 ) e CE OEM Annex II ( ) Annex III (EC ) Annex IV (EC ) Annex V ( ) Annex VI ( ) Annex VII (EC )

2 1 medical device directive MDD [1] /42/EEC 2007/47/EC 1 93/42/EEC 2007/47/EC 93/42/EEC as amended by 2007/47/EC /42/EEC (MDD) : 98/79/EC (, IVD) 90/385/EEC (AIMD) 2 EU ( ) (medical device) / [6] 2 2

3 2.1 : 1. ( ) /385/EEC /83/EC /768/EEC 5. ; 6. ; 7. ; Annex VIII CE (IVD) 98/79/EC /83/EC 2001/83/EC 5 custom-made device; 6 device intended for clinical investigation; 3

4 (transient) (short term) (long term) (invasive device) 2. (body orifice) 3. (surgically invasive device) 4. (implantable device) 5. (reusable surgical instrument) 6. (active medical device) 7 7. (active therapeutical device) 8. (active device for diagnosis) 7 4

5 3.2 Annex IX Class I IIa IIb III 4 : Class I ( ) ( ) ( ) ( ) [1] MEDDEV 2.4/1 (Guidance document classification of medical devices) [3] / / / / / / / / / / / / Class I Class I Class I Class I / / / / Class I Class I 5

6 3.2.3 / / / / ( ) / / / / / / Class I / / / Class I 6

7 3.2.5 / / / X Class I (a) Annex VII (EC ) (b) Annex II, 2. IV, V, VI (a) Annex II ( ) (b) Annex VII (EC ) + Annex IV (EC ) (c) Annex VII (EC ) + Annex V ( ) (d) Annex VII (EC ) + Annex VI ( ) 3. (a) Annex II ( ) (b) Annex III (EC ) + Annex IV (EC ) (c) Annex III (EC ) + Annex V ( ) (d) Annex III (EC ) + Annex VI ( ) 4. (a) Annex II ( ) (b) Annex III (EC ) + Annex IV (EC ) (c) Annex III (EC ) + Annex V ( ) 8 8 7

8 Annex II III IV V VI VII EC EC EC Class I Class I + ( + + ) : 4 Annex II Annex VII Annex VII (EC ) (notified body) Annex II ( ) 1. ; 2. ; EC (EC design-examination certificate) (, IIb ) 3. Annex VII (EC ) + Annex IV (EC ) Annex IV (EC ) Annex VII (EC ) + Annex V ( ) Annex VII (EC ) + Annex VI ( ) 9 Class I 8

9 4. CE 5. EC 4.2 Annex III (EC ) Annex IV (EC ) Annex V ( ) Annex VI ( ) 1. ( ) 2. (a) (b) (c) 3. EC (EC type-examination certificate) EC 4.3 Annex IV (EC ) Annex III (EC ) Annex VII (EC ) 1. EC (a) EC (b) ( ) CE 10 Annex III (EC ) 9

10 5. Annex V ( ) Annex V ( ) Annex III (EC ) Annex VII (EC ) 1. ; 2. CE Annex VI ( ) Annex III (EC ) Annex VII (EC ) 1. ; 2. CE 4.6 Annex VII (EC ) Annex IV (EC ) Annex V ( ) Annex VI ( ) CE 3. Class I Annex II (EC ) IV (EC ) V ( ) VI ( ) 5 Annex I (essential requirements) 10 10

11 5.1 Annex I.I : 1. : (a) (b) / 2. (state of the art) : (a) (b) (c) Annex X ( 9.4 ) 5.2 Annex I.II / 11

12 ; / 2. : (a) (b) (c) STERILE ( ) (d) LOT (e) (f) (g) custom-made device (h) exclusively for clinical investigations (i) / (j) (k) (l) (m) (n) : (a) 12

13 (b) (c) (d) (e) (f) (g) (h) ; (i) ( ) (j) (k) (l) (m) (n) (o) (p) (q) : ; ; ; ;

14 7. ; (Annex X) (Declaration of Conformity; DoC) NB-MED S/01/99 11 : ( 15 ) 11 Consensus Statements of Notified Bodies Medical Devices on Council Directives 90/385/EEC, 93/42/EEC and 98/79/EC Consensus Statement S/01/99: Declaration of Conformity [4] 12 Annex IV (EC ) EC EC 13 S/01/99 14

15 7 CE CE ( 2) CE : ( ) ( ) 2: CE ( ) CE 5mm / CE CE R&TTE CE CE 8 Annex II ( ) Annex V ( ) Annex VI ( ) 14 ( ) EN ISO : 14 Annex VII (EC ) VII (EC ) + Annex IV (EC ) Annex III (EC ) + Annex IV (EC ) 15 ISO 13485, Medical devices Quality management systems Requirements for regulatory purposes 15

16 1. 2. : (a) (b) (harmonised standards) (Official Journal; OJ) [2] EN ( ) EN (EMC ) ( ) 9.2 (Article 14) EU (authorized representative), IIb III 9.3 OEM 93/42/EEC (manufacturer) OEM (own brand labeller ) 16

17 [5] 9.4 / : Article 15 Annex VIII Annex X MEDDEV 2.7 [3] 9.5 MEDDEV 2.12/1 (Guidance document guidelines on a medical devices vigilance system) [3] 9.6 EMC 2004/108/EC EMC EMC 93/42/EEC (amended by 2007/47/EC) Article /95/EC Annex II 2006/42/EC 93/42/EEC Article 3 (EHSR) 17

18 R&TTE 1999/5/EC R&TTE R&TTE Article ( ) R&TTE RoHS 2011/65/EU RoHS WEEE 2002/96/EC, 2012/19/EU WEEE 2006/66/EC 10 [1] 93/42/EEC, Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [2] European Commission Enterprise and Industry Policies Harmonised standards Medical devices [3] Guidance MEDDEVs [4] Team-NB (The European Association for Medical devices of Notified Bodies) [5] Interpretation of the medical device directives in relation to medical device own brand labellers, European Commission, fiche obl en.pdf [6] Revision of the medical device directives, European Commission, 26 September c 2012 e-ohtama, LTD. All rights reserved. 18

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