93/42/EEC ( 2 ) e 2013 10 2 1 2 1.1.............. 2 1.2...... 2 2 2 2.1....... 3 2.2... 3 2.3......... 3 3 3 3.1...... 3 3.1.1............ 4 3.1.2.......... 4 3.2.............. 5 3.2.1......... 5 3.2.2............. 5 3.2.3....... 6 3.2.4 6 3.2.5......... 7 3.3...... 7 6 13 6.1...... 13 6.2.............. 14 6.3............ 14 7 CE 15 8 15 9 16 9.1................ 16 9.2........... 16 9.3 OEM........... 16 9.4................ 17 9.5................ 17 9.6................. 17 10 18 4 8 4.1 Annex II ( ).. 8 4.2 Annex III (EC )....... 9 4.3 Annex IV (EC )......... 9 4.4 Annex V ( )....... 10 4.5 Annex VI ( )...... 10 4.6 Annex VII (EC )...... 10 5 10 5.1.............. 11 5.2....... 11 5.3.................. 12 1
1 medical device directive MDD [1] 1.1 93/42/EEC 2007/47/EC 1 93/42/EEC 2007/47/EC 93/42/EEC as amended by 2007/47/EC 1.2 93/42/EEC (MDD) : 98/79/EC (, IVD) 90/385/EEC (AIMD) 2 EU ( ) (medical device) / 2 1 2012 9 [6] 2 2
2.1 : 1. ( ) 3 2. 90/385/EEC 3. 2001/83/EC 4 4. 76/768/EEC 5. ; 6. ; 7. ; 2.2 5 6 Annex VIII CE 2.3 3 4 3.1 3 (IVD) 98/79/EC 4 2001/83/EC 2001/83/EC 5 custom-made device; 6 device intended for clinical investigation; 3
3.1.1 1. (transient) 60 2. (short term) 30 3. (long term) 30 3.1.2 1. (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
3.2 Annex IX Class I IIa IIb III 4 : Class I ( ) ( ) ( ) ( ) [1] MEDDEV 2.4/1 (Guidance document classification of medical devices) [3] 3.2.1 / / / / / / / / / / / / Class I Class I Class I 3.2.2 Class I / / / / Class I Class I 5
3.2.3 / / / / ( ) / / / / / / Class I 3.2.4 / / / Class I 6
3.2.5 / / / X 3.3 1. 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
Annex II III IV V VI VII EC EC EC Class I Class I + ( + + ) + + + + + + + + + 1: 4 Annex II Annex VII Annex VII (EC ) (notified body) 9 4.1 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
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) 4. 5. EC 4.3 Annex IV (EC ) Annex III (EC ) Annex VII (EC ) 1. EC 10 2. (a) EC (b) ( ) 3. 4. CE 10 Annex III (EC ) 9
5. Annex V ( ) 6. 4.4 Annex V ( ) Annex III (EC ) Annex VII (EC ) 1. ; 2. CE 3. 4.5 Annex VI ( ) Annex III (EC ) Annex VII (EC ) 1. ; 2. CE 4.6 Annex VII (EC ) Annex IV (EC ) Annex V ( ) Annex VI ( ) 1. 2. CE 3. Class I Annex II (EC ) IV (EC ) V ( ) VI ( ) 5 Annex I (essential requirements) 10 10
5.1 Annex I.I : 1. : (a) (b) / 2. (state of the art) : (a) (b) (c) 3. 4. 5. 6. 7. Annex X ( 9.4 ) 5.2 Annex I.II 1. 2. 3. 4. 5. / 11
6. 7. 5.3 1. ; / 2. : (a) (b) (c) STERILE ( ) (d) LOT (e) (f) (g) custom-made device (h) exclusively for clinical investigations (i) / (j) (k) (l) (m) (n) 3. 4. 5. : (a) 12
(b) (c) (d) (e) (f) (g) (h) ; (i) ( ) (j) (k) (l) (m) (n) (o) (p) (q) 6 6.1 : 1. 2. ; ; 3. 4. ; ; 5. 6. 13
7. ; 8. 9. 10. 11. 12. (Annex X) 13. 6.2 (Declaration of Conformity; DoC) NB-MED S/01/99 11 : 12 13 6.3 5 ( 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
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 13485 15 : 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
1. 2. : (a) (b) 3. 9 9.1 (harmonised standards) (Official Journal; OJ) [2] EN 60601-1 ( ) EN 60601-1-2 (EMC ) ( ) 9.2 (Article 14) EU (authorized representative), IIb III 9.3 OEM 93/42/EEC (manufacturer) OEM (own brand labeller ) 16
[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 1.6 2006/95/EC Annex II 2006/42/EC 93/42/EEC Article 3 (EHSR) 17
R&TTE 1999/5/EC R&TTE R&TTE Article 3.2 3.3 ( ) R&TTE RoHS 2011/65/EU 2014 7 22 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 http://eur-lex.europa.eu/lexuriserv/lexuriserv.do?uri=consleg:1990l0385:20071011:en:pdf [2] European Commission Enterprise and Industry Policies Harmonised standards Medical devices http://ec.europa.eu/enterprise/policies/european-standards/harmonised-standards/medical-devices/ [3] Guidance MEDDEVs http://ec.europa.eu/health/medical-devices/documents/guidelines/ [4] Team-NB (The European Association for Medical devices of Notified Bodies) http://www.team-nb.org/ [5] Interpretation of the medical device directives in relation to medical device own brand labellers, European Commission, 2008 http://ec.europa.eu/health/medical-devices/files/guide-stds-directives/interpretative fiche obl en.pdf [6] Revision of the medical device directives, European Commission, 26 September 2012 http://ec.europa.eu/health/medical-devices/documents/revision/ c 2012 e-ohtama, LTD. All rights reserved. 18