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Summary of national notification system: SWEDEN
2. Procedures for
suspension/withdrawal of notification?
3. Possibility to appeal against such
procedures?
2. ASSESSMENT, INCLUDING
ACCREDITATION
Basis for assessment
SWEDAC communicates with the body concerned and gives it an opportunity to correspond and correct the causes for
suspension/withdrawals. If reasons for suspension/withdrawal still exist, SWEDAC makes a recommendation to the government, after
having consulted the sector authorities concerned, to suspend/withdraw the notification. The government makes the decision.
The government's decision can be appealed (to some extent) to the Supreme Administrative Court according to the administrative
decisions act.
1. Use of EN 45000 standards The Swedish Regulation on notified bodies lays down the basic criteria on which the assessment made by SWEDAC rests. It states that
the potential notified body should be competent and suited for the task. Competence in this respect means that in assessing the body in
question SWEDAC must satisfy itself that the potential notified body fulfils the requirements in the relevant standard in the EN 45000 or
ISO-EN (e g ISO-EN 17 025) series as well as any additional requirements laid down in the specific directive.
2. Additional generic requirements SWEDAC evaluates the financial stability and ability of good business behaviour of the notified body prior to the assessment of its
technical competence. If the notified body is a part of a public authority, that part should be clearly separated from the rest of the
authority. In order to avoid conflicts of interest notified bodies should in principle be excluded from responsibilities linked to market
surveillance. In some cases a notified body may be requested by an authority to act as an expert. This should be done with due care to
avoid conflict of interest.
3. Other referentials. If so, which?
Technical competence requirements
1. Directive-specific requirements The concerned regulatory authority or authorities are always approached by SWEDAC before the start of the actual assessment. In
essence this means that in each area a dialogue with the regulatory authority precedes the assessment. The objective of this dialogue is
among other things to pinpoint essential features to be taken into consideration during the assessment. This includes the identification
of the technical competence requirements that should be put on the notified bodies. It could also include specific conditions concerning
the formal education of personnel or to what extent the notification should be limited in scope or time. Normally the regulatory
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