Healthcare Software and the impact of the new Medical Device Regulation in Portugal

Healthcare Software and the New Medical Device Regulation

The new Medical Device Regulation is fully applicable since 26 May 2021, which increases the security and control of medical devices within the European Union. The Medical Device Regulation further clarifies software as a medical device, a classification already covered on the scope of the previous Directive. Being Digital Health a field of focus in Portugal, it is important to understand the impact and preparation of the industry and healthcare professionals to comply with the security and quality requisites for healthcare products, even if they take the shape of digital tools, less common in the past on the clinical practice. 

This event aims to introduce an industry and clinical audience to the basic concepts of software as a medical device, and discuss the readiness of stakeholders to comply with the new requirements during a transition period that may extend, in particular to software manufacturers, until 2024. 

Event Language: Portuguese
Timezone: WEST (Lisbon Time)