The Egyptian Drug Authority (EDA) participated in the international panel discussion entitled “Reality Check: Tracking the Evolving MDR/IVDR Landscape from a Non-EU Perspective,” held in Singapore as part of the “Deep-Dive Session on EU MDR/IVDR and their Impact on International Registrations.” The session was organized in collaboration with MedTech Europe, APACMed, Mecomed, MTAA, and CBDL.
During the session, Dr. Nermeen Sadek Khalil, from the Central Administration for Medical Devices, represented the Egyptian Drug Authority and delivered a presentation highlighting the EDA’s role in regulating medical devices and its efforts to support international regulatory alignment and coordination. The presentation also covered the classification of medical devices under the European MDR and IVDR regulations, as well as the transitional periods associated with their implementation.

The session addressed the impact of the transition from the previous European directives to the EU MDR and EU IVDR on regulatory systems outside the European Union, as well as the key challenges faced by regulatory authorities and industry during the transition to the new regulatory framework. It also explored approaches to preparing for future regulatory changes and updates.

The presentation further highlighted key challenges associated with the transition to the new regulatory framework, including the limited availability of conformity assessment bodies, the reclassification of certain products, transitional periods, and clinical documentation requirements, in addition to a number of regulatory procedures and practices adopted to address these challenges.

The EDA’s participation reflects its commitment to monitoring the latest international regulatory developments in the field of medical devices and strengthening the exchange of expertise and best practices with regulatory authorities and specialized international organizations. This contributes to the development of the regulatory framework and supports efforts to align with relevant international trends and standards.