Ahead of the August 12, 2026 total solar eclipse, which will be visible across Spain as well as parts of Iceland and Greenland, we would like to share an interesting point from a regulatory perspective.
From a regulatory perspective, not every product intended to protect people is classified as a medical device.
Solar viewing glasses are a great example. Designed for direct solar observation, these products raise an interesting regulatory question:
Which regulatory framework applies in Europe?
In the EU, eclipse glasses are regulated as Personal Protective Equipment (PPE) under Regulation (EU) 2016/425. Before they can be placed on the market, they must comply with the applicable essential requirements and undergo the relevant conformity assessment and certification procedures.
If you are planning to use eclipse glasses, it is important to check a few key points before viewing the Sun:
- CE marking
- Reference to ISO 12312-2
- Identification of the manufacturer or importer
- Good filter condition, with no scratches, holes, or visible defects
Important: regular sunglasses are not suitable for this purpose. Homemade filters such as X-rays, CDs, or other improvised materials must not be used for solar observation.
Further information is available in the official guidance issued by the Spanish Government:
https://www.dsca.gob.es/sites/default/files/Eclipse_solar_2026_protege_tus_ojos_A4_V7.pdf
Contact us for your regulatory requirements or further information: [email protected]
