EU Adopts New AI Regulation: Harmonizing AI Rules Across Europe
On July 12th, the EU Artificial Intelligence (AI) Act was published in the Official Journal as Regulation (EU) 2024/1689. The European Union has officially adopted Regulation (EU) 2024/1689, a comprehensive legal framework designed to regulate the development, deployment, and use of artificial intelligence (AI) systems across member states. This landmark legislation, also known as the… Read more
Regulation (EU) No 2024/1860 has been published in the Official Journal of the EU
On July 09 2024, Regulation (EU) No 2024/1860 has been published. This Regulation introduces the following key changes:– a gradual roll-out of Eudamed,-the obligation to inform in case of interruption or discontinuation of supply,-transitional provisions for certain in vitro diagnostic medical devices Only IVDD legacy devices may benefit from the extended transition period if: The… Read more
FDA Issues Quality Management System Regulation: Final Rule Amending the Quality System Regulation
On January 31, 2024, U.S. Food and Drug Administration (FDA) issued the following public announcement: “To ensure medical devices on the market are safe, effective, and of good quality, the U.S. Food and Drug Administration (FDA) issued the Quality Management System Regulation (QMSR) Final Rule. The QMSR rule emphasizes risk management activities and risk-based decision… Read more
Proposal for transitional provisions for certain in vitro diagnostic medical devices under Regulation (EU) 2017/746
European Commission issued a proposal 2024/0021 (COD) for 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 IVDR. Once approved by the council and parliament this will give more time for many IVD manufacturers to comply… Read more
The Number of Medical Device Notified Bodies is increasing
EU Commission has announced EU MDR 2017/745 designation of 42th notified body (NB). The number of Notified Bodies is expected to increase with the issue of the amendment for MDR extension on 20 March 2023 .With increasing number of NBs manufacturers may find more options to certify their devices. Since beginning of 2019, when the… Read more