The Laevo team announced in April 2022 that the Laevo FLEX has received official certification from the European Union as Personal Protective Equipment (PPE), including CE marking.
The Laevo team announced in April 2022 that the Laevo FLEX has received official certification from the European Union as Personal Protective Equipment (PPE), including CE marking. The Laevo FLEX 3.0 is a passive, spring-loaded, back-assisted exoskeleton. It was first unveiled in October 2021 at WearRAcon 21 Europe (Laevo Flex unveiled at WearRAcon Europe 2021). The Laevo FLEX is designed to be worn continuously for the duration of a shift and reduce the risk of back injury while working and fatigue from lifting and bending.
Although there are many exoskeletons and wearable robotic devices bearing the CE mark, the Laevo FLEX is the first to receive a declaration of conformity in accordance with Regulation (EU) 2016/425 on personal protective equipment (PPE). The certification was carried out using the EU Type B/C examination module.
The Laevo FLEX 3.0 is intended to reduce the risk of back injury while working by bending forward, maintaining this posture and returning to standing, squatting and lifting weights. Intended use includes: reducing the risk of back injury while working and fatigue from bending and lifting.
PPE products intended for sale in Europe require additional testing and certification, separated into three categories. The Laevo FLEX 3.0 certification is likely a Category II – requiring certification by a Notified Body in Europe.
PPE or no PPE?
There is an ongoing debate in the exoskeleton community as to whether professional exoskeletons should be considered personal protective equipment or not. The Laevo FLEX 3.0 PPE CE mark allows it to be sold and marketed as PPE in Europe, but it can still be implemented as a cheat sheet instead. Laevo’s announcement, however, brings considerable substance in favor of treating exos like safety gear, similar to a helmet, steel-toed shoes, or a fall protection harness. This is a monumental step forward for the entire field of exo technology.
First PPE-certified exoskeleton in the world! Discover the Laevo FLEXApril 11, 2022, Laevo News, (link)