Embracing Innovation: Regulatory Frameworks in Digital Health
The sector has seen a surge in innovative solutions over the past decade, including digital health technologies, telemedicine, AI in diagnostics, and personalized care. In this context, regulation in the healthcare industry has become increasingly critical and a key topic of discussion. The growing complexity of these innovations has raised challenges related to safety, ethics, data privacy, and equity, which require careful regulatory oversight.
At present, establishing a robust regulatory framework where the intended use is clearly defined and aligned with the product's real-world application is essential. When discussing a healthcare product with international reach, such as Mediktor, only a comprehensive approach could reduce the complexity of multiple registrations under different regulatory systems worldwide.
The transition from the Medical Devices Directive (MDD) to the Medical Device Regulation (MDR) in the European Union (EU) sets stricter and more comprehensive requirements for medical devices to improve safety, transparency, and post-market surveillance. The deadline for this transition has passed for some products, and it has become paramount to ensure compliance with the new requirements to maintain market access and the safety and performance of the product.
As many details contribute to defining a product and its associated services, confusion may arise when determining the classification of each medical device. A common misconception is that Software as a Medical Device (SaMD) can no longer be classified as Class I under the MDR. These assertions are not only inaccurate but also counterproductive for the industry. Class I is designated for intended uses not involving diagnostic tools, physiological monitoring, or other high-risk factors.
During the ongoing digital revolution, the landscape of intended uses for software has become increasingly diverse. As a result, many applications extend beyond simply providing diagnostic information. Numerous medical solutions now support various processes that do not focus on diagnosis or treatment, including prevention, prediction, and prognosis. A prime example of a Class I Medical Device is Mediktor. This all-in-one platform can predict potential illnesses a patient may have, thereby facilitating access to the most appropriate healthcare service.
At Mediktor, we continuously strive to meet the highest standards of all applicable regulations to ensure patient safety and the security of our partners. As the entire sector gains experience and we forge new paths, the digital revolution in healthcare presents the best opportunity to navigate through regulations and leverage all the possibilities it offers.