MDR: Medical Devices Regulation

IVDR: In Vitro Diagnostic Medical Devices Regulation

The EU adopted these regulations in 2017, and they introduce more stringent cybersecurity rules for medical devices on the EU market.

Medical Devices Regulation (MDR)

MDR focuses on the regulation of medical devices, which include a wide range of products used for medical purposes. This regulation aims to ensure a high level of safety and effectiveness of medical devices in the EU market. It includes updated requirements for the design, manufacturing, and clinical performance of medical devices.

In Vitro Diagnostic Medical Devices Regulation (IVDR)

IVDR, on the other hand, specifically addresses in vitro diagnostic medical devices. These are medical devices used to perform tests on samples, such as blood or tissue, outside the body to diagnose diseases or conditions. IVDR introduces new and enhanced rules for the regulation of these diagnostic devices to ensure their safety and reliability.

• PARTICIPATION IN EVENTS

One of the factors that show our expertise is the active participation of Cyen members as speakers at forums and conferences. This active involvement enhances the company’s reputation as a leading authority in cybersecurity. As a result, Cyen has become a trusted resource for businesses, and individuals seeking cutting-edge cybersecurity solutions.

Some of the forums were:

• Iva Tasheva presented the EU Cybersecurity Legislation for the Health Sector Overview at an event organised by SoCyber and Enterprise Magazine.
• PARAi – Professional Association of Robotics, Automation and Innovations AI, automation & robotics event in Sofia, BG. Our representative was Eva Saeva
• Panel on Protecting Critical Infrastructures: European and global cyber security efforts in a geopolitically volatile world at the 10th European Cyber Security Conference in Brussels, organised by Forum Europe with the strategic partnership of European Cyber Security Organisation (ECSO). Our representative was Iva Tasheva
• Panel about data privacy at the 1st European Conference on Cybersecurity by Women4Cyber Foundation in Madrid, Spain. 
• Our Founder, Iva Tasheva has delivered a presentation on the Bio Supply Management Alliance (BSMA) annual event on the Biotech and Pharma Supply Chain. Iva has put a special focus on how companies can improve their status quo by ensuring that every link of the supply chain is protected from cyber threats.