Systemic Standards – 专业产品安全服务。卓越合规。

Technical File Pre-Audit & EU Responsible Person (GPSR)

(Gap Analysis for GPSR Compliance Readiness)

Would you like to appoint us as your EU Responsible Person according to the General Product Safety Regulation (GPSR)? In order to bindingly assess whether your products meet the legal requirements of the GPSR in the EU, we conduct a fee-based Technical File Pre-Audit (Gap Analysis) beforehand.

During this gap analysis, we review your documentation for completeness, compliance with the current EU specifications, and authenticity. Please complete the following form as thoroughly as possible.

1. Company Details (Applicant)

2. Product Details & Market History

Is the product already available on the European or international market?
Have there been any regulatory complaints, sales bans, safety warnings, or product recalls for this product or identical models (inside or outside the EU)?
Is this product (identical in construction, material, and technology) supplied by the production facility to other distributors or sold under other brands in the EU?

3. Documents & Supporting Evidence

Please upload all available documentation for your product below. The more complete the documents are, the faster we can perform your Pre-Audit.

Tip: You can select multiple documents sequentially from different folders or upload a single compressed ZIP archive.

Available test reports regarding general safety, physical/mechanical hazards (e.g., sharp edges, choking hazards), or stress tests.

No files selected

Evidence regarding hazardous substance testing and thresholds (e.g., REACH, RoHS, Lead, Cadmium, Phthalates, OEKO-TEX, FSC).

No files selected

Draft of the product label, rating plate (including model number, batch number, manufacturer details) or packaging graphics.

No files selected

The current user manual, assembly guides, safety rules, or drafts of planned user information leaflets.

No files selected

Manufacturer risk analyses, existing declarations of conformity (DoC), or voluntary test certificates.

No files selected

Copy of the current commercial policy or an English Certificate of Insurance showing active coverage for the EU market.

No files selected

High-resolution images of the product from all angles, detailed shots of warning labels, and construction drawings.

No files selected

4. Process and Next Steps

1. Commissioning the Pre-Audit: You will receive an invoice regarding the fee for the Technical File Pre-Audit.
2. Conducting the Gap Analysis: Upon acceptance, receipt of payment, and all documentation, we will cross-reference your files in detail with current EU GPSR requirements.
3. Evaluation Report: You will receive a detailed report outlining whether your documentation is sufficient or highlighting gaps and additional laboratory tests that are strictly required.
4. Onboarding & Mandate: Following a successful audit outcome (or once documented gaps have been resolved), the official mandate agreement appointing us as your EU Responsible Person for the EU market will be finalized.
(Optional: Here you can inform us about important details regarding your product, deadlines, or internal project notes)