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July 2025 — Is Your Technical File Traceable or Just a PDF Dump?

  • Writer: Team Hoodin
    Team Hoodin
  • Jul 3
  • 2 min read

Linking GSPR claims to current regulations, standards, and common specifications

As of mid-2025, Notified Bodies are applying increased scrutiny to technical documentation — especially under Annex II Section 4. It's no longer acceptable to declare conformity and attach supporting files. You must demonstrate traceability between each conformity claim and the exact regulation, standard, or common specification that supports it — and show that these sources are current.


This traceability must also integrate with your QMS under ISO 13485 §4.1.3, which requires regulatory requirements to be embedded in system-level processes, not just appended to documents.


You may use AI tools such as ChatGPT, Gemini, CoPilot, or AI-enhanced regulatory tools such as Hoodin to create traceability mappings that are up to date, structured, and version-controlled.

Operational Focus

Map all GSPR claims and conformity methods to valid, monitored regulatory sources — per product, per market

Each claim must: – Be traceable to an authoritative source (regulation, harmonised standard, or CS) – Include a justification for its selection – Be version-controlled, reviewed, and updated when the source changes



Step-by-Step Execution

  1. Extract the full list of GSPR claims from your technical documentationEnsure each claim includes intended method of conformity (e.g. testing, standard, design control)

  2. Identify the original regulatory source for each method – Harmonised standard (if still valid) – Common specification (if applicable) – Specific article or annex within MDR/IVDR – Cross-domain law (e.g. RoHS for electrical safety, REACH for chemical substances)

  3. Check current status of each source – Withdrawn? Superseded? Still harmonised? – Note changes in scope, applicability, or citation date – For CS, verify current applicability per product type and class

  4. Use AI to generate traceability linksMap each conformity claim to the latest version of its source. Add justification if an outdated standard is still used (with risk-based reasoning)

  5. Embed links into your technical fileEnsure cross-references between GSPR section, Annex II §4, and referenced sources are clear and audit-ready

  6. Set up ongoing review triggersIf any source updates, the traceability map must be reviewed and documented as part of your QMS update process


How Hoodin Helps

With Hoodin’s Smart Compliance List, you can:

  • Receive a live, market-specific regulatory bundle for your product

  • View current status of each harmonised standard or CS

  • Get AI-generated traceability suggestions per GSPR item

  • Track changes across 1,500+ regulations, including updates to standards and cross-domain acts

  • Maintain a structured, linked, and versioned traceability file for audits Start you 14-day free trial here



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