Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices (COM(2024) 43 final); (26 page(s), in English)

Quality Control Standards for the Medical Device Distribution (Draft); (32 page(s), in Chinese)

Notice of Proposed Rulemaking and Announcement of Public Hearing: Amendments to Article 6, Clear and Reasonable Warnings Safe Harbor Methods and Content; (9 page(s), in English)