2010/713/EU: Commission Decision of 9 November 2010 on modules for the procedures... (32010D0713)
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2010/713/EU: Commission Decision of 9 November 2010 on modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability adopted under Directive 2008/57/EC of the European Parliament and of the Council (notified under document C(2010) 7582) Text with EEA relevance
- COMMISSION DECISION
- of 9 November 2010
- on modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability adopted under Directive 2008/57/EC of the European Parliament and of the Council
- (notified under document C(2010) 7582)
- (Text with EEA relevance)
- (2010/713/EU)
- Article 1
- Subject matter
- Article 2
- Scope
- Article 3
- Definitions
- Article 4
- Conformity assessment procedures
- Article 5
- Procedure for assessment of suitability for use
- Article 6
- EC verification procedures
- Article 7
- Subsidiaries of and subcontracting by notified bodies
- Article 8
- Application
- Article 9
- Addressees
- ANNEX I
- Modules for the procedures for assessment of conformity, suitability for use and EC verification to be used in the technical specifications for interoperability
- MODULES FOR CONFORMITY ASSESSMENT OF INTEROPERABILITY CONSTITUENTS
- Module CA.
- Internal production control
- 2. Technical documentation
- 3. Manufacturing
- 4. EC declaration of conformity
- 5. Authorised representative
- Module CA1.
- Internal production control plus product verification by individual examination
- 2. Technical documentation
- 3. Manufacturing
- 4. Product checks
- 5. EC certificate of conformity
- 6. EC declaration of conformity
- 7. Authorised representative
- Module CA2.
- Internal production control plus product verification at random intervals
- 2. Technical documentation
- 3. Manufacturing
- 4. Product checks
- 5. EC certificate of conformity
- 6. EC declaration of conformity
- 7. Authorised representative
- Module CB.
- EC-type examination
- Module CC.
- Conformity to type based on internal production control
- 2. Manufacturing
- 3. EC declaration of conformity
- 4. Authorised representative
- Module CD.
- Conformity to type based on quality management system of the production process
- 2. Manufacturing
- 3. Quality management system
- 4. Surveillance under the responsibility of the notified body
- 5. EC declaration of conformity
- 8. Authorised representative
- Module CF.
- Conformity to type based on product verification
- 2. Manufacturing
- 3. Verification
- 4. Verification of conformity by examination and testing of every interoperability constituent.
- 5. Statistical verification of conformity
- 6. EC declaration of conformity
- 7. Authorised representative
- Module CH.
- Conformity based on full quality management system
- 2. Manufacturing
- 3. Quality management system
- 4. Surveillance under the responsibility of the notified body
- 5. EC declaration of conformity
- 8. Authorised representative
- Module CH1.
- Conformity based on full quality management system plus design examination
- 2. Manufacturing
- 3. Quality management system
- 4. Design examination
- 5. Surveillance under the responsibility of the notified body
- 6. EC declaration of conformity
- 8. Authorised representative
- MODULES FOR SUITABILITY FOR USE OF INTEROPERABILITY CONSTITUENTS
- Module CV.
- Type validation by in-service experience (suitability for use)
- 5. Type validation by in-service experience
- 11. EC declaration of suitability for use
- 12. Authorised representative
- MODULES FOR EC VERIFICATION OF SUBSYSTEMS
- Module SB.
- EC-type examination
- Module SD.
- EC verification based on quality management system of the production process
- 2. Manufacturing
- 3. Quality management system
- 5. EC verification
- 7. Surveillance under the responsibility of the notified body
- 8. EC certificate of verification and EC declaration of verification
- 9. The applicant shall, throughout the service life of the subsystem, keep at the disposal of the national authorities:
- 11. Authorised representative
- Module SF.
- EC verification based on product verification
- 2. Manufacturing
- 3. The applicant shall lodge an application for the EC verification of the subsystem with a notified body of his choice.
- 4. EC verification
- 5. EC declaration of verification
- 7. Authorised representative
- Module SG.
- EC verification based on unit verification
- 2. The applicant shall lodge an application for the EC verification of the subsystem with a notified body of his choice.
- 3. Technical documentation
- 4. Manufacturing
- 5. EC verification
- 6. EC declaration of verification
- 8. Authorised representative
- Module SH1.
- EC verification based on full quality management system plus design examination
- 2. Manufacturing
- 3. Quality management system
- 4. EC verification
- 5. Surveillance under the responsibility of the notified body
- 6. EC certificate of verification and EC declaration of verification
- 7. The applicant shall, throughout the service life of the subsystem, keep at the disposal of the national authorities:
- 9. Authorised representative
- ANNEX II
- ANNEX III
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