Describe what was done
Record replacement parts, altered software, testing, changed intended functions and how the product was supplied afterwards. A refurbished label says little about whether the work restored original performance or changed the product's safety profile. Product identifiers and revision history are particularly useful.
Check substantial modification
Article 4(18) and Article 8(2) provide the relevant framework for a modification that can result in manufacturer treatment. First check the applicable safety-law threshold. Where the Directive's fallback test applies, document the performance, purpose or type change and the hazard or risk change.
Preserve the original and later chains
An investigation may need records from the original manufacturer and the refurbishing business. Separate the original product's market date from the modified product's later supply or use date. Article 17 includes a special starting point for a substantially modified product; that should not be applied to every repair automatically.
Records that help the review
Use the following as a practical starting point. Select and preserve records appropriate to the product, incident and applicable procedure.
- Repair and replacement-part records
- Before and after product specifications
- Testing and intended-use statements
- Original and later supply dates
A repair is not necessarily a substantial modification. A new responsibility finding cannot be inferred from the label alone.
Primary sources and legal scope
This page explains the EU Directive framework. Check national implementing law, the corrected temporal scope and relevant procedure before applying it to a case.
- Directive (EU) 2024/2853, consolidated text: Articles 4, 7, 8, 17 ↗
- Official Journal corrigendum, 7 May 2026: Article 2(1) ↗
Source register: corrected scope verified 16 October 2026. Article references identify the legal basis. No qualified legal review or national implementation status is claimed.