EU CE Certification (3)

• Harmonised standards, what are they?
• Declaration of conformity
• Roles in CE Marking, the manufacturer, importer, distributor and more

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• What does it mean to have a quality system under Module D/D1?
• Is ISO 9001 required?
• When must I inform the Notified Body of a change in my system, and do you do another audit?

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• What are the costs + timelines?
• Expiry date of Module B?
• What is the Module C or Module D that follows Module B

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