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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:

• 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:

• 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

📥 Instant Download – Get your files immediately after purchase!

📜 Format: Editable Word documents (DOCX) and PDF

⚠ Who should use this?

🔹 Gum Shield (Mouthguard) Manufacturers

🔹 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

Compliance

Toy Safety Directive 

Instant Access

Instant Access

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Type of File

Type of File

PDF & Word

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