Systemic Standards – Competence in Product Safety. Excellence in Compliance.

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 files at once or upload a 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 of pollutant testing and limit values (e.g., REACH, RoHS, lead, cadmium, phthalates, OEKO-TEX, FSC).

No files selected

Please upload the draft of the product label / rating plate (including model number, batch/serial number, manufacturer data, and placeholder for the EU Responsible Person).

No files selected

The current user manual, assembly instructions, safety warnings, or drafts of planned QR codes / weblinks (at least in English).

No files selected

Manufacturer's own risk analyses (especially regarding vulnerable groups such as children/seniors) or voluntary conformity certificates.

No files selected

Copy of the current policy or Certificate of Insurance in English with active coverage for the EU market.

Note: If sufficient insurance coverage is not yet in place, proof must be provided prior to official mandate assumption.

No files selected

High-resolution images of the product from all sides as well as the sales packaging.

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.