Understanding Europe's Medical Device Regulation скачать в хорошем качестве

Understanding Europe's Medical Device Regulation

Effective May 26th 2021, the European Union Medical Device Regulation (MDR) governing market access to the European market, is the most significant regulatory change in over 20 years. With the recommended directives under the MDR, there is an important 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 24 Jun, discussed the expected regulatory reciprocities in Asia (e.g. Singapore has recently published rafted UDI guidelines), the impact of such requirements on mid-size/smaller industry players, and how the MedTech industry can leverage this "new era" of transparency in the public-private value chains.