The long-awaited publication of the new robot standards EN ISO 10218‑1:2025 and EN ISO 10218‑2:2025 in the Official Journal of the European Union has now officially taken place. With their publication on September 7, 2026, both standards have been granted the status of harmonized standards with a presumption of conformity under the Machinery Directive.
Figure: AI generated with Microsoft Copilot (2026)
More legal certainty
Thanks to their listing in the Official Journal, manufacturers and integrators can assume that compliance with the standards automatically implies compliance with the essential health and safety requirements of the Machinery Directive (presumption of conformity). For manufacturers, integrators, and operators of industrial robots, this finally provides legal certainty regarding the application of the updated safety requirements
Table: Effective Dates of the EN-ISO Standards and the Associated Presumption of Conformity
| Validity of the standard | Presumption of conformity a.t. | ||||
| Machinery Directive 2006/42/EG | Machinery Regulation (EU) 2023/1230 | ||||
| Begin | End | Begin | End | Begin | |
| EN ISO 10218-1:2025 | Mar. 2025 | – | 2026-09-07 | 2027-01-20 | In preparation |
| EN ISO 10218-2:2025 | Mar. 2025 | – | 2026-09-07 | 2027-01-20 | In preparation |
| EN ISO 10218-1:2011 | Jul. 2011 | Mar. 2027 | 2011-11-18 | 2027-01-20 | None |
| EN ISO 10218-2:2011 | Jul. 2011 | Mar. 2027 | 2011-11-18 | 2027-01-20 | None |
Unfortunately, this presumption of conformity will be short-lived. This is because it still refers to the currently valid Machinery Directive (see table). However, this Machinery Directive will be replaced by the Machinery Regulation on January 20, 2027. As a result, the presumption of conformity that has just been announced will expire once again. This is not only the case for robot standards. Many other harmonized European standards are also affected.
Currently, the standards bodies are working intensively to verify that all standards listed under the Machinery Directive are compliant with the new Machinery Regulation. This is because the Machinery Regulation replaces the Machinery Directive. A new EU Official Journal will be published shortly regarding this matter. It is expected that EN ISO 10218-1:2025 and EN ISO 10218-2:2025 will be listed therein again as harmonized standards compliant with the Machinery Regulation.
