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GPSR Technical Documentation Review and Gap Analysis

Grüner Baum GmbH reviews an existing product file against GPSR Article 9 and the other EU product rules that apply to that product. The published €129 service covers one product family's detailed risk and document-gap review; it is not a product certificate and does not transfer the manufacturer's duties.

What does the €129 GPSR document review include?

The review starts with the actual product version and available evidence. Grüner Baum records what exists, what is missing and which item needs correction before a broader service or Article 16 mandate is proposed.

Published price€129 / product family
ScopeOne product family's detailed risk assessment and technical-document gap analysis.
InputsProduct description, materials or composition, intended users, risk record, test reports, standards, labels, warnings and instructions where available.
DeliverableA written gap list that maps missing, inconsistent or outdated evidence to the product version and the applicable requirement.
Not includedLaboratory testing, a universal GPSR certificate, marketplace approval or an automatic full-file drafting package.
Legal ownerThe manufacturer performs the internal risk analysis, draws up and updates the technical documentation, and keeps it available for 10 years under Article 9.

Beyond the free initial risk analysis included in the packages; covers a formal, detailed review of technical documents, test reports, product information and the risk assessment from a GPSR perspective. High-risk products or products subject to specific legislation are quoted separately.

Do you need a review, preparation support or a Responsible Person?

The correct route depends on the evidence already available, the product-specific law and the real supply chain. These services are related but not interchangeable.

Your situationCorrect routeResult
An existing file needs checking€129 document-gap reviewProduct-specific list of missing, inconsistent or outdated evidence.
No usable technical file existsScoped preparation support after intakeA written work plan and quote; the manufacturer supplies and approves the product facts and remains the legal owner.
CE or sector-specific law appliesProduct-law assessment and custom quoteThe GPSR safety-net file is aligned with the separate declaration, testing or conformity-assessment duties.
A non-EU manufacturer lacks the correct Article 16 operatorSupply-chain check, then written Responsible Person mandate if appropriateA Germany-based Article 16 route for the accepted product scope; annual plans start at €249 plus VAT.

Looking for a GPSR technical documentation template?

The separate technical-file guide reproduces the three sections of the European Commission's optional model: product identification, product characteristics and composition, and a risk-by-risk mitigation record. It also explains which Article 9 items are always required and which depend on the product's possible risks.

Open the Article 9 contents and model-template guide

How does Grüner Baum review GPSR technical documentation?

Each review follows the product and its evidence rather than a generic certificate checklist.

  1. 1. Fix the product scope

    Record model, variants, intended use, users, manufacturer, EU sales channels and the actual economic operators.

  2. 2. Freeze the evidence version

    Match drawings, materials, test reports, standards, labels, instructions and risk records to the same product version.

  3. 3. Map the legal requirements

    Separate the GPSR Article 9 baseline from any CE, sector-specific or national requirements that also apply.

  4. 4. Deliver the gap record

    State each missing or conflicting item, who owns the correction and what evidence is needed before the file can be treated as complete.

What the GPSR document review does not prove

  • A document review does not certify that a product is safe or compliant with every applicable law.
  • The European Commission model template is optional and does not replace product-specific evidence.
  • GPSR Article 9 does not require an independent laboratory report for every product; testing depends on the risk evidence and any other applicable product law.
  • A consultant or Responsible Person service does not transfer the manufacturer's Article 9 duties.

This page describes the technical-document review performed by Germany-based Grüner Baum GmbH. Reviewed by Hatice Muazzez Bodur →

GPSR technical documentation review: questions and answers

Who must prepare GPSR technical documentation?

GPSR Article 9 places the internal risk analysis and technical-documentation duty on the manufacturer. A consultant may structure or review the evidence, and an Article 16 operator may verify and make required documents available within its statutory role, but the manufacturer's duty is not transferred.

Is the European Commission GPSR model template compulsory?

No. Commission Notice C/2025/6233 states that its model may help draft and organise technical documentation and is not compulsory. The file still has to satisfy Article 9 for the actual product.

Is a bill of materials mandatory in every GPSR technical file?

GPSR Article 9 does not name a bill of materials as a universal minimum field. The Commission model asks for product characteristics, material and composition; a detailed bill of materials may be needed when the product, risk analysis or other applicable EU law makes component evidence relevant.

Does every product need an independent laboratory test?

No. Article 9 refers to test reports where appropriate for the product's possible risks. Product-specific EU law may separately require testing or conformity assessment.

Can one technical file cover several SKUs?

Only if the same description and evidence genuinely cover the relevant design, materials, intended users and safety characteristics. A safety-relevant change requires a documented check and, where necessary, a new or revised assessment.

Primary legal sources

Start with one product family

Send the product description and the documents you already have. Grüner Baum will identify the first evidence gaps before proposing any wider scope.