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CHAPTER 4 CONFORMITY ASSESSMENT AND NOTIFICATION OF CONFORMITY ASSESSMENT BODIES
CHAPTER 5 UNION MARKET SURVEILLANCE, CONTROL OF PRODUCTS, SAFEGUARD PROVISIONS
CONFORMITY ASSESSMENT PROCEDURES
I. MODULE B: EC TYPE-EXAMINATION
1. EC type-examination is the part of a conformity assessment procedure...
2. EC type-examination may be carried out in either of the...
3. The manufacturer shall lodge an application for EC type-examination with...
5. The notified body shall draw up an evaluation report that...
6. Where the type meets the requirements of the specific international...
7. If the approved type no longer complies with the applicable...
8. Each notified body shall inform its notifying authorities concerning the...
9. The manufacturer shall keep a copy of the EC type-examination...
10. The manufacturer’s authorised representative may lodge the application referred to...
II. MODULE D: CONFORMITY TO TYPE BASED ON QUALITY ASSURANCE OF...
1. Conformity to type based on quality assurance of the production...
3.1. The manufacturer shall lodge an application for assessment of its...
3.2. The quality system shall ensure that the products are in...
3.3. The notified body shall assess the quality system to determine...
3.4. The manufacturer shall undertake to fulfil the obligations arising out...
3.5. The manufacturer shall keep the notified body that has approved...
4. Surveillance under the responsibility of the notified body
6. The manufacturer shall keep at the disposal of the competent...
7. Each notified body shall inform its notifying authorities of quality...
III. MODULE E: CONFORMITY TO TYPE BASED ON PRODUCT QUALITY ASSURANCE...
1. Conformity to type based on product quality assurance is that...
3.1. The manufacturer shall lodge an application for assessment of its...
3.2. The quality system shall ensure compliance of the products with...
3.3. The notified body shall assess the quality system to determine...
3.4. The manufacturer shall undertake to fulfil the obligations arising out...
3.5. The manufacturer shall keep the notified body that has approved...
4. Surveillance under the responsibility of the notified body
6. The manufacturer shall keep at the disposal of the competent...
7. Each notified body shall inform its notifying authorities of quality...
IV. MODULE F: CONFORMITY TO TYPE BASED ON PRODUCT VERIFICATION
REQUIREMENTS TO BE MET BY CONFORMITY ASSESSMENT BODIES IN ORDER TO BECOME NOTIFIED BODIES
1. For the purposes of notification, a conformity assessment body shall...
2. A conformity assessment body shall be established under national law...
3. A conformity assessment body shall be a third-party body independent...
4. A body belonging to a business association or professional federation...
5. A conformity assessment body, its top-level management and the personnel...
6. A conformity assessment body, its top-level management and the personnel...
7. Conformity assessment bodies shall ensure that the activities of their...
8. Conformity assessment bodies and their personnel shall carry out the...
9. A conformity assessment body shall be capable of carrying out...
10. At all times and for each conformity assessment procedure and...
11. A conformity assessment body shall have the means necessary to...
12. The personnel responsible for carrying out conformity assessment activities shall...
13. The impartiality of the conformity assessment bodies, of their top-level...
14. The remuneration of the top-level management and of the assessment...
15. Conformity assessment bodies shall take out liability insurance unless liability...
16. The personnel of a conformity assessment body shall observe professional...
17. Conformity assessment bodies shall participate in, or ensure that their...
18. Conformity assessment bodies shall meet the requirements of standard EN...
19. Conformity assessment bodies shall ensure that testing laboratories used for...
2.1. Notifying authorities may notify only conformity assessment bodies which have...
2.2. They shall notify the Commission and the other Member States...
2.3. The notification shall include full details of the conformity assessment...
2.4. Where a notification is not based on an accreditation certificate...
2.5. The body concerned may perform the activities of a notified...
2.7. The Commission and the other Member States shall be notified...
REQUIREMENTS TO BE MET BY NOTIFYING AUTHORITIES
1. A notifying authority shall be established in such a way...
2. A notifying authority shall be organised and operated in such...
3. A notifying authority shall be organised in such a way...
4. A notifying authority shall not offer or provide, on a...
5. A notifying authority shall safeguard the confidentiality of the information...
6. A notifying authority shall have a sufficient number of competent...