9. in order to protect the manufacturers, the technical documentation provided to notified bodies has to be limited to that which is required solely for the purpose of assessment of conformity. Legal protection of confidential information shall be required;



10. whenever directives provide the manufacturer with the possibility of using modules based on quality assurance techniques, the manufacturer must also be able to have recourse to a combination of modules not using quality assurance, and vice versa, except where compliance with the requirements laid down by the directives requires the exclusive application of a certain procedure;



11. for the purposes of operating the modules, Member States shall notify on their own responsibility bodies under their jurisdiction which they have chosen from the technically competent bodies complying with the requirements of the directives. This responsibility involves the obligation for the Member States to ensure that the notified bodies permanently have the technical qualifications required by the directives and that the latter keep their competent national authorities informed of the performance of their tasks. Where a Member State withdraws its notification of a body, it shall take appropriate steps to ensure that the dossiers are processed by another notified body to ensure continuity;



12. in addition, with regard to conformity assessment, the sub-contracting of work shall be subject to certain conditions guaranteeing:



• the competence of the establishment operating as sub-contractor, on the basis of conformity with series EN 45000 standards, and the capability of the Member State that has notified the sub-contracting body to ensure effective monitoring of such compliance;
• the ability of the body notified to exercise effective responsibility for the work carried out under sub-contract;


13. notified bodies which can prove their conformity with harmonized standards (EN 45000 series), by submitting an accreditation certificate or other documentary evidence, shall be presumed to conform to the requirements of the directives. Member States having notified bodies unable to prove their conformity with the harmonized standards (EN 45000 series) may be requested to provide the Commission with the appropriate supporting documents on the basis of which notification was carried out;



14. a list of Notified Bodies shall be published by the Commission in the Official Journal of the European Communities and constantly updated."

Note:   Lists of Notified Bodies are published by the European Commission in the "Official Journal of the European Communities." A hard copy may be requested from Mrs. Janette AISTROPE, Tel: 011-322-299-9060, Fax: 011-322-296-0851, E-mail Janette, Aistrope@cec.eu.int. At present, these lists are not available electronically.

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