Regulation (EU) 2024/2847 · Chapter
Article 41 — Subsidiaries of and subcontracting by notified bodies
Subsidiaries and subcontracting: outsourcing assessment without outsourcing responsibility.
LAW Official text — verbatim from the Official Journal snapshot; only the Official Journal is authentic.
1.1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 39 and shall inform the notifying authority accordingly.
2.2. Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever they are established.
3.3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the manufacturer.
4.4. Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under this Regulation.
sha256:27b7c6c64c773001… · CELEX 32024R2847What this article does
Article 41 lets notified bodies use subcontractors and subsidiaries for specific assessment tasks, under conditions: the subcontractor or subsidiary meets the Article 39 requirements, the notifying authority is informed, the manufacturer agrees, and the notified body takes full responsibility for the tasks wherever the subcontractor or subsidiary is established — keeping the relevant documents on their qualifications and work at the disposal of its notifying authority.
Why manufacturers should skim it
If your certificate matters to your market access, note that subcontracting or use of a subsidiary needs your agreement as manufacturer, so ask early which entity will actually test your product. The accountability stays with the notified body either way; the logistics and timelines may differ.
Editorial review: Claude (AI reviewer, delegated by the editor), 2026-10-08. Methodology and correction process: how this site works.