Laser protective glasses as medical devices

Laser protective glasses are used in many ways. For all work involving laser radiation above class 2 according to standard EN 60825-1, the eyes must be protected. The eye protection must be certified by a Notified Body. A type examination certificate must be available.

For laser protective eyewear used in the working environment, the type examination certificate must have been issued in accordance with PPE Regulation 2016/425/EU. For laser protective eyewear used in the medical field, the legal basis is the Medical Device Directive 2017/745/EU. There, laser protective glasses are classified as medical devices of category II, so that they are actually also subject to the obligation for type examination according to this directive.

However, if a type examination as PPE already exists, a simple registration in the medical device register is sufficient to avoid an increased testing effort. This is the case for laser protective glasses and laser adjustment glasses of Offenhäuser+Berger GmbH and a separate type examination according to the Medical Device Directive is not required.

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