MDR certification

Biomag – Karel Hrnčíř has successfully completed the certification process in accordance with the European MDR (2017/745). The Biomag Lumina 3D-e and Biomag Lumio 3D-e pulsed magnetic therapy devices are among the first in Europe to comply with the European Medical Device Regulation 2017/745 (MDR).

Main objectives of the MDR:

1. Improving the quality, safety, and reliability of medical devices: The MDR introduces stricter requirements for clinical evaluation, risk assessment, and post-market monitoring to ensure that all medical devices are safe and effective.
2. Ensuring transparency and accessibility of information for patients and healthcare professionals: The MDR requires that information on medical devices be easily accessible and understandable. This includes the introduction of the European Database on Medical Devices (EUDAMED), which collects information on all medical devices available on the EU market.
3. Strengthening market surveillance and control: The MDR enhances regulators’ powers for market surveillance and manufacturer inspections to ensure that all medical devices meet the highest standards of safety and performance.
4. Introducing stricter rules for certification and monitoring: Medical device manufacturers must undergo a more stringent conformity assessment process before placing their products on the market. This includes strengthening the role of the so-called “Notified Bodies,” which carry out independent assessments of products.
5. Improving post-market monitoring: The MDR requires manufacturers to have systems in place to actively monitor their products after market launch, enabling rapid responses to any safety issues.
6. Ensuring better coordination between EU Member States: The MDR aims to harmonize medical device regulations across the EU, facilitating cooperation and information sharing between Member States.

Overall, the MDR represents a significant step towards strengthening the regulation of medical devices in the EU, with the aim of increasing patient protection while promoting innovation and sustainability in the healthcare sector.

The certificate awarded to us by 3EC International confirms that we manufacture products in accordance with the latest and most stringent EU standards.