Pronova Laboratories

Pronova receives CE certification for Licener Head Lice Treatment

pack-shot Licener

In September 2025, Pronova Laboratories achieved a world first: CE certification for its head lice treatment Licener as a Class IIa medical device under the European Medical Device Regulation (MDR).

For over a decade, Licener has been trusted across continents as a safe, effective over-the-counter treatment against head lice. But with the EU’s sweeping regulatory reform, the familiar landscape changed dramatically. The new MDR redefined the rules for medical devices — and demanded far more than just proof that a product works.

Licener’s effectiveness and safety had already been well established through clinical trials and years of surveillance on real-world use. Yet the MDR brought a new challenge: (re-)proving every aspect of product design, testing, and monitoring within a unique, European, hyper-integrated framework, often to an almost philosophical degree.

While the additional control and record-keeping load continued to be internationally argued to be excessive, especially for smaller organizations, Pronova saw it as an opportunity: from the ground up, its team designed a lean, modern quality system that not only meets the MDR’s expectations but showcases transparency, control, and continuous improvement.

Even with that solid foundation, the road to CE certification wasn’t exactly a walk in the park. As now learned by many, the MDR might well ask you to prove the sky is blue, and you’d better reference the latest ISO standard on colour measurement while you’re at it.

But perseverance pays off. Every re-test, every review, every audit reinforced the true value of Licener: a plant-based, one-step solution that helps families worldwide deal with head lice safely and effectively, without compromise or comparison.

As the season turns, Licener stands certified and shining — officially the first Class IIa device of its kind registered under the MDR in the European database. It’s a milestone that opens the door to an even brighter future, both within and beyond the EU.