- Floodlight™ MS complies with the new EU Medical Device Regulation (MDR), reinforcing confident use by patients and their healthcare providers
- MDR certification provided by an independent notified body confirms Floodlight™ MS meets high standards of quality and safety for market access in the EU
- Ensuring compliance with the new MDR further proves Roche’s ability to develop clinically relevant digital solutions, strengthening its position as a trusted partner in digital healthcare
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that Floodlight™ MS, a smartphone app that enables data-driven clinical conversation and healthcare provider decision-making on a patient’s multiple sclerosis (MS), has achieved MDR certification. MDR certification is required to commercialise medical devices in the European Union.
For people living with MS and their healthcare providers, this certification reinforces the safety, efficacy and performance of Floodlight™ MS and further supports their confidence in using the app to help guide personalised care decisions,
said Moritz Hartmann, Global Head of Roche Information Solutions of the company’s Diagnostics Division.
The certification is representative of Roche’s commitment to Digital Healthcare, backed by clinical data and supported by clinical evaluation, quality management systems and risk management procedures.
MDR certification requires significant organisational process and rigor, the creation and maintenance of a quality management system and risk management procedures, and the demonstration of clinical validation and usability of medical devices. The certification also assesses cybersecurity measures for a product and demonstrates compliance with data security requirements. The Floodlight™ MS solution is compliant with ISO27001, the international standard for information security for cloud-based products and with GDPR and HIPAA data privacy regulations. Getting Floodlight™ MS MDR-certified highlights that Roche has these capabilities and that they meet or exceed the stringent review by independent notified bodies.
Being able to bring MDR certified software as a medical device to market enables Roche to deliver clinically-relevant digital solutions that have the potential to meaningfully support patient care and outcomes in a timely manner.