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 …
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 …
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 …
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 …
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 …
European Commission published the official text of the proposal to extend the MDR transition period for legacy devices on 6 January 2023. The amendment has been formally adopted by both the European Parliament and the Council on 15 March 2023.On 20 March 2023,it has been published in the Official Journal and entered into force. As …
MDCG 2023-3-The guidance document on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices has been published by MDCG. The purpose of this guidance is to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). This …
Proposal for transitional provisions for certain invitro diagnostic medical devices under Regulation (EU) 2017/746 European Commission issued a proposal (2021/0323 (COD)) for the amendment of the transitional provisions under EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). Once approved by the council and parliament this will give more time for many IVD manufacturers …
The guidance document MDCG 2020-21– Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 which is highly anticipated has been published on 16 December 2022 by MDCG. The guidance document, which provides information about the content, format and frequency of preparation for the PSUR, which must be prepared during and after the …
ISO 14644-4 Cleanrooms and associated controlled environments — Part 4: Design, construction and start-up has been revised. ISO made some changes by renewing the standard, which was first published in 2001, at the end of last month. The main changes in the new version are as follows: 1. The normative content has been expanded;2. Added …