Guide to the implementation of directives based on the New ...

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Contents 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 1.1. Concept <strong>of</strong> <strong>the</strong> New Approach and <strong>the</strong> Global Approach . .7 1.2. Standard elements <strong>of</strong> New Approach <strong>directives</strong> . . . . . . . .8 1.3. Adoption <strong>of</strong> New Approach <strong>directives</strong> . . . . . . . . . . . . . .10 1.4. Transposition <strong>of</strong> New Approach <strong>directives</strong> . . . . . . . . . . .11 1.5. New Approach <strong>directives</strong> . . . . . . . . . . . . . . . . . . . . . .12 2. Scope <strong>of</strong> New Approach <strong>directives</strong> . . . . . . . . .15 2.1.Products submitted <strong>to</strong> <strong>directives</strong> . . . . . . . . . . . . . . . . . .15 2.2. Simultaneous application <strong>of</strong> <strong>directives</strong> . . . . . . . . . . . . . .16 2.2.1. New Approach <strong>directives</strong> . . . . . . . . . . . . . . . . . . . . .16 2.2.2. New Approach <strong>directives</strong> and <strong>the</strong> Directive on general product safety . . . . . . . . . . . . . . . . . . . . . . . . . . .17 2.2.3. New Approach <strong>directives</strong> and <strong>the</strong> Directive on product liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17 2.3. Placing on <strong>the</strong> market and putting in<strong>to</strong> service . . . . . . . .18 2.3.1. Placing on <strong>the</strong> market . . . . . . . . . . . . . . . . . . . . . .18 2.3.2. Putting in<strong>to</strong> service . . . . . . . . . . . . . . . . . . . . . . . .19 2.4. Transitional period . . . . . . . . . . . . . . . . . . . . . . . . . . .19 3. Responsibilities . . . . . . . . . . . . . . . . . . . . . . . .21 3.1. Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21 3.1.1. New Approach <strong>directives</strong> . . . . . . . . . . . . . . . . . . . . .21 3.1.2. The Directives on product liability and general product safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22 3.2. Authorised representative . . . . . . . . . . . . . . . . . . . . . .22 3.3. Importer/person responsible for placing on <strong>the</strong> market . .23 3.4. Distribu<strong>to</strong>r . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23 3.5. Assembler and installer . . . . . . . . . . . . . . . . . . . . . . .24 3.6. User (employer) . . . . . . . . . . . . . . . . . . . . . . . . . . . .25 3.7. Product liability . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25 4. Compliance with <strong>directives</strong> . . . . . . . . . . . . . . .27 4.1. Essential requirements . . . . . . . . . . . . . . . . . . . . . . . .27 4.2. Harmonised standards . . . . . . . . . . . . . . . . . . . . . . . .27 4.3. Presumption <strong>of</strong> conformity . . . . . . . . . . . . . . . . . . . . .29 4.4. Withdrawal <strong>of</strong> <strong>the</strong> presumption <strong>of</strong> conformity . . . . . . . . .29 4.5. Revision <strong>of</strong> harmonised standards . . . . . . . . . . . . . . . .30 5. Conformity assessment procedure . . . . . . . . .31 5.1. The modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31 5.2. Application <strong>of</strong> quality system standards . . . . . . . . . . . . .33 5.3. Technical documentation . . . . . . . . . . . . . . . . . . . . . .34 5.4. EC declaration <strong>of</strong> conformity . . . . . . . . . . . . . . . . . . . .34 6. Notified bodies . . . . . . . . . . . . . . . . . . . . . . . .36 6.1. Principles <strong>of</strong> notification . . . . . . . . . . . . . . . . . . . . . . .36 6.2. Notification procedure and withdrawal <strong>of</strong> notification . . . .38 6.2.1. Notification procedure . . . . . . . . . . . . . . . . . . . . . .38 6.2.2. Withdrawal <strong>of</strong> notification . . . . . . . . . . . . . . . . . . . .39 6.3. General responsibilities <strong>of</strong> notified bodies . . . . . . . . . . .39 6.4. Notified bodies and conformity assessment . . . . . . . . . .41 6.5. Notified bodies and subcontracting . . . . . . . . . . . . . . .42 6.6. Coordination and cooperation . . . . . . . . . . . . . . . . . . .43 7. CE marking . . . . . . . . . . . . . . . . . . . . . . . . . . .44 7.1. Principles <strong>of</strong> CE marking . . . . . . . . . . . . . . . . . . . . . .44 7.2. Products <strong>to</strong> be CE marked . . . . . . . . . . . . . . . . . . . . .44 7.3. Affixing <strong>of</strong> <strong>the</strong> CE marking . . . . . . . . . . . . . . . . . . . . .45 7.4. CE marking and o<strong>the</strong>r marks . . . . . . . . . . . . . . . . . . .46 8. Market surveillance . . . . . . . . . . . . . . . . . . . . .47 8.1. Principles <strong>of</strong> market surveillance . . . . . . . . . . . . . . . . .47 8.2. Market surveillance activities . . . . . . . . . . . . . . . . . . . .48 8.2.1. Moni<strong>to</strong>ring <strong>of</strong> products placed on <strong>the</strong> market . . . . . . .48 8.2.2. Corrective actions . . . . . . . . . . . . . . . . . . . . . . . . .50 8.2.3. Complementary activities . . . . . . . . . . . . . . . . . . . .51 8.3. Safeguard clause procedure . . . . . . . . . . . . . . . . . . . .52 8.3.1. Conditions for invoking <strong>the</strong> safeguard clause . . . . . . .52 8.3.2. Notification <strong>to</strong> <strong>the</strong> Commission . . . . . . . . . . . . . . . . .53 8.3.3. Administering <strong>the</strong> safeguard clause . . . . . . . . . . . . . .54 8.4. Protection <strong>of</strong> CE marking . . . . . . . . . . . . . . . . . . . . . .54 8.5. Information exchange systems . . . . . . . . . . . . . . . . . .55 8.5.1. Consumer products: rapid exchange <strong>of</strong> information . . .55 8.5.2. Medical devices: vigilance system . . . . . . . . . . . . . .56 8.5.3. Community injury data-collection and information exchange system . . . . . . . . . . . . . . . . . . . . . . . . .56 8.5.4. O<strong>the</strong>r information exchange systems at Community level . . . . . . . . . . . . . . . . . . . . . . . .56 8.6. Administrative cooperation . . . . . . . . . . . . . . . . . . . . .57 8.6.1. Outline for administrative cooperation . . . . . . . . . . . .57 8.6.2. Infrastructures for administrative cooperation . . . . . . .58 8.7. Products imported from third countries . . . . . . . . . . . . .59 9. External aspects . . . . . . . . . . . . . . . . . . . . . . .62 9.1. Agreement on <strong>the</strong> European Economic Area . . . . . . . . .62 9.1.1. Basic elements <strong>of</strong> <strong>the</strong> Agreement . . . . . . . . . . . . . . .62 9.1.2. Notification <strong>of</strong> bodies . . . . . . . . . . . . . . . . . . . . . . .62 5
❝ <strong>Guide</strong> <strong>to</strong> <strong>the</strong> <strong>implementation</strong> <strong>of</strong> <strong>directives</strong> <strong>based</strong> on <strong>the</strong> New Approach and <strong>the</strong> Global Approach ❞ 9.1.3. Safeguard clause procedure . . . . . . . . . . . . . . . . . .62 9.1.4. Mutual recognition agreements and European conformity assessment pro<strong>to</strong>cols . . . . . . . . . . . . . . .63 9.2. Mutual recognition agreements . . . . . . . . . . . . . . . . . .63 9.3. European conformity assessment pro<strong>to</strong>cols . . . . . . . . . .64 9.4. Technical assistance . . . . . . . . . . . . . . . . . . . . . . . . .64 9.5. WTO Agreement on Technical Barriers <strong>to</strong> Trade . . . . . . .65 Annexes Annex 1: Community legislation referred <strong>to</strong> in <strong>the</strong> <strong>Guide</strong> . . . . .67 Annex 2: Additional information concerning certain Articles <strong>of</strong> <strong>the</strong> Treaty establishing <strong>the</strong> European Community (<strong>the</strong> EC Treaty) . . . . . . . . . . . . . . . . . . . . . . . . . .71 Annex 3: Additional guidance documents . . . . . . . . . . . . . . .74 Annex 4: Commission contact points . . . . . . . . . . . . . . . . .77 Annex 5: Useful web addresses . . . . . . . . . . . . . . . . . . . . .79 Annex 6: Products submitted <strong>to</strong> New Approach <strong>directives</strong> . . . .80 Annex 7: Contents <strong>of</strong> conformity assessment procedures . . . .84 Annex 8: Flow chart presentation <strong>of</strong> conformity assessment procedures as provided for by <strong>the</strong> <strong>directives</strong> . . . . . .89 6
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