Insight into European regulations on medical devices
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Effective May 26, 2021, the European Union's Medical Device Regulation (MDR), which governs market access to the European market, is the most significant regulatory change in more than two decades. With the recommended guidelines under the MDR, there is a significant global shift towards traceability, transparency and post-approval maintenance of medical devices to ensure the highest possible standard in this safety-critical industry.
This webinar, held on June 24, discussed the expected regulatory reciprocity in Asia (for example, Singapore recently published a set of UDI guidelines), the impact of such requirements on medium/smaller industry players, and how the MedTech industry can make use of this. new era/" of transparency in public-private value chains.
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