The Laevo Team announced in April 2022 that the Laevo FLEX has received official European Union certification as a Personal Protective Equipment (PPE), including the CE mark. The Laevo FLEX 3.0 is a passive, spring-loaded, back assist 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 work shift and reduce the risk of back injuries during work and fatigue due to lifting and bending.
While there are numerous exoskeleton and wearable robotics devices that have a CE Mark, the Laevo FLEX is the first one to be awarded a declaration of conformity in accordance with Personal Protective Equipment (PPE) Regulation (EU) 2016/425. The certification was performed using the EU type-examination Module B/C.
The Laevo FLEX 3.0 is intended to reduce the risk of back injuries during work while bending forward, holding this posture, and returning upright, squatting, and lifting weights. Intended use includes: reducing the risk of back injuries during work and fatigue due to bending and lifting.
PPE products to be sold 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 Not PPE?
There is an ongoing debate in the exoskeleton community if occupational 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 job aid instead. The announcement by Laevo, however, does lend considerable substance in favor of exos being treated as safety gear, similar to a hard hat, steel toe shoes, or fall protection harness. This is a monumental step forward for the entire field of exo technology.
First PPE certified exoskeleton in the world! Meet the Laevo FLEX, April 11, 2022, Laevo News, (link)
The CE mark is simply a declaration by the manufacturer that it meets all applicable laws and harmonised directives, it’s a bit misleading to say that it is “awarded” as such.
Hi John, to the best of my understanding, a PPE CE Mark is more stringent and the Laevo Flex 3.0 was tested at an independent lab.
Dear Bobby, that is correct. The Laevo FLEX has been given an EU Declaration of Conformity that has been given by an Italian notified body. The declaration describes that the Laevo FLEX is in conformity with the PPE Regulation (EU) 2016/425. The tests have been performed over the span of almost one year in conjunction with the NB testing protocol and all relevant harmonised standards. All the best, Rogier
Are the methods/ test protocol and the results published or reported anywhere?