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Summary of national notification system: SWEDEN 1. written reports? • Content The notified body must keep SWEDAC informed about its work as a notified body and in particular report any changes that might affect its position and appointment as a notified body. • Frequency There is no stipulated frequency for reports. The NBs are requested to inform SWEDAC about changes and other questions concerning their activities at the surveillance. 2. Reporting of information to competent authorities on incorrect use of CE mark and/or certificates issued by NB Monitoring of subcontracted activities and activities of foreign subsidiaries No general regulations or demands exist but specific legislation corresponding to some of the new approach directives (e g medical devices directive) are implemented (see also lin between authorities and notified bodies). The notified body must report to SWEDAC any use of subcontractors and for what tasks the notified body intends to use the subcontractor. The notified body takes full responsibility for the competence of its subcontractor, who must meet the same requirements concerning technical competence as the notified body itself. The notified body must keep a register of its subcontractors. The register must contain detailed information on the competence of the subcontractors and their ability to meet the relevant requirements. 5
Summary of national notification system: THE NETHERLANDS SOGS/WG1 N018 1. ROLES AND RESPONSIBILITIES General 1. co-ordination: centralised / decentralised system? 2. role of accreditation 3. relationship between accreditation body and public authorities Responsible authorities: 1. for notification 2. for designation 3. for assessment Link between authorities and notified body Responsibility for the administration and regulation of compliance with the Directives, including the designation of notified bodies, is shared by a number of different departments. In the early 1990s, an inter-departmental co-ordinating commission was formed to unify the designation policies of the various Ministries. The commission, the Interdepartmental Commission for Normalisation and Certification (ICN) is chaired by the Ministry of Economic Affairs and has now established joint designation policies in a number of key areas. However, visible differences remain, which are often due to sector-specific issues. In line with the European recommendations, accreditation is widely used in the Netherlands, through the designation of notified bodies. Almost all designated bodies are accredited. The accrediting organisation in the Netherlands is the Dutch Accreditation Board (RvA), based in Utrecht, which is a member of the EA. The RvA is a private non-profit organisation. The Ministry of Economic Affairs is represented in the RvA Management Committee. In order to facilitate effective co-ordination of RvA accreditations and Ministerial designations in statutory designation processes (including designations of notified bodies), the government and the RvA contracted a private agreement in 1994. Among other things, this agreement governs the tuning of accreditation and the compliance with the requirements of European Directives (the application of the directive-specific accreditation schemes), RvA procedures for reporting to the government and the RvA surveillance on notified bodies. The agreement also determines the RvA’s willingness to assess bodies wanting designation as a notified body on the basis of the EN45000 standards, without this assessment resulting in an accreditation agreement with the body concerned. Permanent representation in Brussels The Minister responsible for the policy area in question takes the decision on designation (in practice the responsible policy unit of the ministry in question together with the relevant inspection service) The Minister responsible for the policy area in question takes the decision on designation (in practice the responsible policy unit of the ministry in question together with the relevant inspection service)
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- Seite 47 und 48: Benennende, Anerkennende, Akkrediti
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- Seite 113 und 114: The main requirement lies in assess
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- Seite 117 und 118: EUROPÄISCHE KOMMISSION GENERALDIRE
- Seite 119 und 120: vereinbarten Umfang zu kontrolliere
- Seite 121 und 122: Schlussfolgerungen 18. Es liegen ni
- Seite 123 und 124: FINNLAND Herrn Evangelos Vardakas E
- Seite 125 und 126: 2. Verteilung der Zuständigkeit -2
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- Seite 133 und 134: Akkreditierungslogos Nur akkreditie
- Seite 135 und 136: Meldeverfahren Möchte der Antragst
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Summary of national notification system: THE NETHERLANDS SOGS/WG1 N018<br />
1. ROLES AND RESPONSIBILITIES<br />
General<br />
1. co-ordination: centralised /<br />
decentralised system?<br />
2. role of accreditation<br />
3. relationship between accreditation<br />
body and public authorities<br />
Responsible authorities:<br />
1. for notification<br />
2. for designation<br />
3. for assessment<br />
Link between authorities and notified body<br />
Responsibility for the administration and regulation of compliance with the Directives, including the designation of notified bodies, is<br />
shared by a number of different departments. In the early 1990s, an inter-departmental co-ordinating commission was formed to unify the<br />
designation policies of the various Ministries. The commission, the Interdepartmental Commission for Normalisation and Certification<br />
(ICN) is chaired by the Ministry of Economic Affairs and has now established joint designation policies in a number of key areas.<br />
However, visible differences remain, which are often due to sector-specific issues.<br />
In line with the European recommendations, accreditation is widely used in the Netherlands, through the designation of notified bodies.<br />
Almost all designated bodies are accredited. The accrediting organisation in the Netherlands is the Dutch Accreditation Board (RvA),<br />
based in Utrecht, which is a member of the EA. The RvA is a private non-profit organisation.<br />
The Ministry of Economic Affairs is represented in the RvA Management Committee. In order to facilitate effective co-ordination of RvA<br />
accreditations and Ministerial designations in statutory designation processes (including designations of notified bodies), the<br />
government and the RvA contracted a private agreement in 1994. Among other things, this agreement governs the tuning of<br />
accreditation and the compliance with the requirements of European Directives (the application of the directive-specific accreditation<br />
schemes), RvA procedures for reporting to the government and the RvA surveillance on notified bodies. The agreement also determines<br />
the RvA’s willingness to assess bodies wanting designation as a notified body on the basis of the EN45000 standards, without this<br />
assessment resulting in an accreditation agreement with the body concerned.<br />
Permanent representation in Brussels<br />
The Minister responsible for the policy area in question takes the decision on designation (in practice the responsible policy unit of the<br />
ministry in question together with the relevant inspection service)<br />
The Minister responsible for the policy area in question takes the decision on designation (in practice the responsible policy unit of the<br />
ministry in question together with the relevant inspection service)
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