歐盟 MDR 與 IVDR 改革：建立更高效框架的里程碑提案

This depends on whether the migration affects the software's performance or intended purpose. According to MDCG 2020-3, changes to the "operating environment" are generally not considered significant if they don't alter the algorithm or user interface. However, if the cloud migration involves a change in how the software processes data or affects its cybersecurity profile, a Notified Body may deem it significant. We recommend a formal Significant Change Assessment to document why this move does not invalidate your legacy status.

Actually, the 2024 reform (Regulation 2024/1860) accelerates the mandatory use of certain EUDAMED modules. Instead of waiting for the entire system to be ready, the EU will make individual modules mandatory as they become functional. Actor registration, UDI/Device registration, and Certificates/Notified Body modules are expected to become mandatory as early as Q4 2025 or early 2026. Manufacturers should not wait; you should begin the registration process now to avoid a "bottleneck" once the legal mandate takes effect.

Not necessarily. According to Regulation (EU) 2023/607, there is a critical distinction between "Placed on the Market" and "Made Available." 1. The "Placed on the Market" Hurdle: To sell your stock, it must have been "placed on the market" before your MDD certificate expired (or before the end of your specific extension period). This means you must have already transferred ownership (or have a written agreement to transfer) to a distributor or the end-user. ◦ If the devices are still in your warehouse (the manufacturer's control) and your certificate expires without a valid MDR extension, you cannot legally sell them to a distributor. They are "trapped" stock. 2. The "Made Available" (Sell-off) Freedom: If the devices were legally placed on the market (e.g., already sold to and sitting in a distributor’s warehouse) before your certificate lapsed, then yes, they can be "made available" (resold) to hospitals or patients without any regulatory cut-off date. 3. The Practical Limit (Shelf Life): While the law has no end date, the device is limited by its physical/chemical expiry date. You cannot sell an MDD-compliant device past its shelf life, and you cannot relabel it or extend the shelf life under the MDD once your certificate is gone.