Bike Labyrinth is classified as a Class I medical device (non-invasive) and complies with the latest Medical Device Regulation (MDR) established by the European Union: Regulation (EU) 2017/745. It stands for quality and reliability.

Why is it important?

The CE marking shows that our product has undergone the proper procedures to ensure safety, performance, and usability.

This includes a risk analysis based on international standards such as ISO 14971, regular testing and performance evaluation in line with IEC 62366-1:2015 (Usability Engineering File), and monitoring of product use in the market (Post-market Surveillance). These processes are in compliance with the EU Medical Device Regulation (MDR) (EU 2017/745).

We are also registered in the European Database on Medical Devices (EUDAMED): Bike Labyrinth.

What does this mean for healthcare providers?

Safety:
The CE mark shows that the product is designed and tested to minimize any potential risk to users or patients.

Reliable quality:
You can trust that Bike Labyrinth meets European standards for functionality and performance.

Market approval:
Our product may be freely sold and distributed within the EU and EEA.

Procurement requirement in healthcare:
The CE mark is often a prerequisite for hospitals, healthcare organizations, and suppliers to purchase and use a medical product within their institution.

In short, the CE mark gives you confidence that you're investing in a product that meets the highest standards for safety, usability, and regulatory compliance.

Want to know more about this or Bike Labyrinth? Contact us at info@bikelabyrinth.com