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Summary of national notification system: SWEDEN SOGS/WG1 N017
1. ROLES AND RESPONSIBILITIES
General
1. co-ordination: centralised /
decentralised system?
The Swedish Act and Ordinance of Conformity Assessment identifies SWEDAC as the sole body in Sweden to assess and notify
notified bodies to the Commission. It is responsible for assessment and surveillance, designation and notification.
2. role of accreditation Accreditation is not a prerequisite for a notification. However, the assessment procedure is the same as for accreditation. In assessing a
potential notified body SWEDAC takes into account any existing EA/IAF MLA signatory accreditation held by the applicant. SWEDAC
needs to satisfy itself of the relevance of the presented accreditation but seeks to avoid any duplication of work already carried out and
to focus on the additional assessment needed to fulfil the requirements in the directive.
3. relationship between accreditation
body and public authorities
Responsible authorities:
SWEDAC is the national accreditation body for Sweden. It is a public body operating under the responsibility of the Swedish Ministry
of Foreign Affairs.
1. for notification SWEDAC, through Sweden’s Permanent Representation in Brussels.
2. for designation SWEDAC
3. for assessment SWEDAC. The assessment and reassessment of notified bodies is done in close co-operation with the regulatory authority in the
specific area covered by the directive.
Link between authorities and notified body
1. Legal link: Contract, legal act, other? According the regulation (STAFS 1998:3) of notified bodies, the notified body shall inform SWEDAC and other competent authorities
about its work as a notified body. Further it shall also, upon request, provide SWEDAC and the competent authorities with relevant
information on individual assignments.
As a general principle (according to the blue book) the notified bodies shall provide the surveillance authorities with relevant
information for the purpose of market surveillance (see also "Reporting requirements").