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

The official text of MDR extension has been published

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… Read more

MDCG 2023-3 Guidance has been published

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… Read more