Compliance with the General Product Safety Directive
Manufacturers need to determine the applicable standards for the product, at European, and/or international and/or national level, and then identify the appropriate conformity assessment module according to the product characteristics. The technical documentation to be compiled per product type should include the following:
- Safety Evaluation and Risk Assessment Report,
- Complete (exhaustive) list of standards your product is currently complying with (EN, international or nationals),
- Declaration of Conformity of the product,
- Quality Management System in place or ISO Certificate,
- Instructions of Use including any relevant warning concerning the correct use of the product and explanation of any possible risks your product expose the end user to,
- Labeling: labels should clearly mention both manufacturer's name and complete details (address, tel., fax, email address) and the "European Authorized Representative" complete details (name, address, email address),
- Vigilance & Traceability activities such as tracking any compliants reported by the users.
Learn more:
- The Directive: Overview of GPSD 2001/95/EC
- Authorized Representative
- Post-Market Surveillance
- Risks of Non-Compliance
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