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Summary of national notification system: SWEDEN
informed? standardisation.
Liability insurance SWEDAC must ascertain that the notified body has public liability insurance unless the notified body is a public authority (in that case
the state is responsible for any damage caused by the notified body).
1. Amount Neither the act, ordinance nor the regulation on conformity assessment or any other regulation specifies a liability assurance amount for
notified bodies. The NBs are requested to analyze the risks involved when it comes to decide upon an amount.
2. Type of risks covered The insurance should cover damage on persons and property as well as economic damage.
3. MONITORING & SURVEILLANCE
Responsibility for monitoring
1. designation authority SWEDAC is responsible for the surveillance of notified bodies.
2. accreditation body (if applicable)
Practical aspects
1. means of surveillance (witnessed
assessments, audits, documentation review,
etc.)
2. frequency
The yearly surveillance and reassessment follow the same principles as in accreditation. SWEDAC performs so-called witnessed
assessments. This means that as one element of the assessment and surveillance process, SWEDAC from time to time, accompanies the
notified body during the its assessment of a manufacturer. This will give SWEDAC a picture of the notified body at work and provides
guidance for SWEDAC in assessing the notified body.
• of surveillance The notified body will be subject to monitoring on a yearly basis.
• of re-assessment, if applicable The notified body will be subject to a complete reassessment every fourth year.
Reporting requirements
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