On July 5, 2023, TMDA released a draft of Guidelines for handling unfit Medical Devices and...
Revolutionizing Medical Device Regulation: Swissmedic Unveils Swiss Database Innovation
Due to the outdated agreement between Switzerland and the EU on conformity assessments, Swissmedic now handles the registration of economic operators and medical devices, including unique identification. Manufacturers must follow both Swiss and EU regulations, including specific articles from the EU Medical Device and In Vitro Diagnostic Regulations. These rules will take effect later in Swiss regulations once the necessary database is ready.
Introducing swissdamed: A Modern Solution
In response to these evolving requirements, Swissmedic introduced the Swiss Database on Medical Devices or swissdamed. This cutting-edge IT system serves as a comprehensive platform for the application of Swiss regulations pertaining to medical devices and in vitro diagnostic medical devices. The system operates through two interconnected modules, granting access exclusively to registered users. Additionally, it offers an accessible search function for public use.
The rollout of swissdamed will take place through distinct releases, encompassing different modules:
ACT Module (Available Early 2024): This module addresses the registration of companies and economic operators. It streamlines the process and ensures compliance with the latest regulations.
UDI Module (Available from Summer 2024): The UDI module focuses on registering devices and their unique identification, enhancing traceability and accountability.
Successful Pilot Phase and the Road Ahead
In June 2023, a pivotal pilot phase was executed, involving 17 pioneering companies that volunteered to test module 1 of swissdamed. This module caters to the registration of companies and economic operators. The outcome was marked by success, with the tests yielding positive results. The invaluable feedback and constructive comments gathered during this phase have paved the way for enhancements to the swissdamed platform. These refinements will be incorporated before the platform's launch in early 2024.
As Switzerland takes proactive strides to adapt its medical device regulations and streamline the registration process, swissdamed emerges as a beacon of efficiency and modernization. It stands poised to revolutionize how manufacturers, economic operators, and regulatory bodies interact within the dynamic landscape of medical device oversight.
Find the full resource HERE and more information on their legal basis and timeline, as well as planned updates and outages.
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