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Gum Shields (Mouthguards) - Compliance Risk Assessment Template and Technical File Checklist (EU &UK)
Gum Shields (Mouthguards) - Compliance Risk Assessment Template and Technical File Checklist (EU &UK)
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Gum Shields (Mouthguards) Compliance Risk Assessment & Technical File Checklist (EU & UK)
Ensure Your Gum Shields Meet EU and UK Safety Regulations
Stay compliant with the EU General Product Safety Regulation (GPSR 2023/988) and UK Product Safety Regulations with this essential Gum Shields Compliance Pack.
This downloadable pack includes:
✅ Risk Assessment Template
A structured guide to identify and mitigate potential risks associated with gum shields (mouthguards), covering hazards such as:
A structured guide to identify and mitigate potential risks associated with gum shields (mouthguards), covering hazards such as:
• Material biocompatibility (risk of allergic reactions or toxicity)
• Choking hazards (in case of shield breakage)
• Fit and mechanical safety (injury due to poor fit or material failure)
• Chemical exposure (materials such as plastics and dyes)
Essential for ensuring compliance with relevant safety standards.
✅ Technical File Checklist
A comprehensive checklist designed to help manufacturers, importers, and compliance officers create a legally required technical file. It includes sections for:
A comprehensive checklist designed to help manufacturers, importers, and compliance officers create a legally required technical file. It includes sections for:
• CE or UKCA Marking documentation (if applicable)
• Biocompatibility Reports and Material Safety Data Sheets (MSDS)
• Mechanical Safety and Impact Testing Reports
• Traceability Information (batch numbers, manufacturer/importer details)
• Labelling and Instruction Manual Review
Why You Need This?
✔ Required for selling gum shields in the EU and UK markets
✔ Helps avoid penalties, product bans, or recalls
✔ Saves time by organizing compliance documentation efficiently
✔ Essential for online marketplaces (Amazon, Etsy, eBay) requiring proof of regulatory compliance
✔ Helps avoid penalties, product bans, or recalls
✔ Saves time by organizing compliance documentation efficiently
✔ Essential for online marketplaces (Amazon, Etsy, eBay) requiring proof of regulatory compliance
📥 Instant Download – Get your files immediately after purchase!
📜 Format: Editable Word documents (DOCX) and PDF
📜 Format: Editable Word documents (DOCX) and PDF
⚠ Who should use this?
🔹 Gum Shield (Mouthguard) Manufacturers
🔹 Importers & Distributors
🔹 Compliance Officers
🔹 Product Managers
🔹 Importers & Distributors
🔹 Compliance Officers
🔹 Product Managers
Ensure your gum shields meet safety regulations and avoid compliance risks.
Download now and stay legally compliant! 🚀
Key Features
- Risk Assessment Template – Provided in both Microsoft Word and PDF formats for easy customization.
- Compliant with latest GPSR requirements.
- Includes guidance notes and examples
- Regular updates with legislation changes
Compliance
Toy Safety Directive
Instant Access
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Type of File
PDF & Word
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