Laser safety and CE marking

For the manufacturer or importer: compliance with the Machinery Directive (with the Machinery Regulation from 20 January 2027), declaration of conformity, instructions in the national language stating the class, the power and the nominal ocular hazard distance (NOHD), key control, emergency stop, protection against unintended triggering and fibre break detection. For the user: laser safety officer, controlled laser area, protective walls or curtains, fume extraction and certified protective equipment.

Sources: Suva, checklist 67205 (January 2026); EN ISO 11553-2:2008

Yes, in Switzerland, for the use of class 3B and 4 lasers: they are among the particular hazards listed in FCOS Directive 6508, and Suva requires the appointment of a laser safety officer whose tasks are defined by management. The law does not specify the training: a course, instruction from the manufacturer or self-study. We train laser safety officers and users.

Sources: Suva 66049, 4.1; FCOS Directive 6508, Annex 1

Generally not: a set-up designed by a laboratory for its own research is not placed on the market, and a machine specially designed for research and used temporarily in a laboratory is excluded from the Machinery Regulation. Researchers’ safety, however, remains mandatory: risk assessment, laser area, protective measures and training.

Sources: Regulation (EU) 2023/1230, Art. 2(2)(m); Suva 66049

For the manufacturer: these devices fall under the Medical Device Regulation (Annex XVI) even without a medical purpose, with common specifications specific to lasers and intense pulsed light. In Switzerland, people who carry out these treatments have had to hold a certificate of competence since 1 June 2024, and certain treatments are reserved for physicians.

Sources: Regulation (EU) 2017/745, Annex XVI, point 5; Implementing Regulation (EU) 2022/2346; V-NISSG; FOPH

The manufacturer. IEC 60825-1 assigns it responsibility for classification. Classification is based on measuring the accessible emission under all operating conditions, including any reasonably foreseeable single fault, and comparing it with the accessible emission limits of each class. We carry out these measurements and document the classification in a report.

Sources: IEC 60825-1:2014, 4.2, 4.3 and clause 5

EN 60825-1:2014 with its European amendment A11:2021, which adopts IEC 60825-1:2014 (edition 3). The combined reference has been published in the Official Journal under the Low Voltage Directive since 21 December 2021; EN 60825-1:2014 alone no longer gives a presumption of conformity since 21 June 2023.

Sources: List of harmonised standards under Directive 2014/35/EU (OJ L 457 of 21.12.2021)

Class 3R may exceed the maximum permissible exposure under direct intrabeam viewing, but with a low risk in most cases. Class 3B is hazardous to the eye under direct viewing, even briefly; diffuse reflections are normally safe. Class 4 is hazardous to the eye and skin, including through diffuse reflection, and often presents a fire risk. Design requirements increase accordingly: key control, remote interlock connector, emission indicator, beam stop.

Sources: IEC 60825-1:2014, Annex C.2 and clause 6

Yes, it is the final product that is classified, not the component. The module may change class depending on how it is integrated: optics, control, fault conditions. If the product does not exceed the class 1 limit under any condition, it is exempt from the other requirements of the standard, but you must be able to demonstrate this.

Sources: IEC 60825-1:2014, clause 1 and 4.3

Yes, except in class 1. Since 1 June 2021, the import, transit, offering, supply and possession of laser pointers of classes 1M, 2, 2M, 3R, 3B and 4 have been prohibited. These rules derive from the V-NISSG ordinance, in force since 1 June 2019.

Sources: V-NISSG; FOPH, laser pointers

It depends on the class. Classes 1 and 1M: an explanatory label, which the manufacturer may instead place in the user information. From class 1C: the laser hazard symbol and an explanatory label. Depending on the class, the aperture label, information on the emitted radiation and the standard applied, and access panel labels are added. An exempt product is not subject to these requirements.

Sources: IEC 60825-1:2014, clause 1, 7.2 and 7.3

Laser products there fall under the FDA and the performance standard 21 CFR 1040.10. With Laser Notice 56, the FDA accepts conformity with the comparable clauses of IEC 60825-1 ed. 3 in place of the corresponding requirements. The product must be certified and identified, and many products must be reported to the FDA.

Sources: FDA, Laser Notice No. 56 (21.02.2023); 21 CFR 1002.1, 1010.2, 1010.3 and 1040.10