The European Commission has recently released a comprehensive Q&A document designed to assist manufacturers and other stakeholders in understanding the new amendment concerning the phased implementation of EUDAMED. This amendment, introduced through Regulation (EU) 2024/1860, was published in mid-June and addresses three key areas within the framework of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Below is an overview of the topics covered by the amendment:
1. Extended Transition Periods for IVD Conformity Assessments
The amendment aims to uphold high standards of patient safety and public health while mitigating the risk of shortages of in vitro diagnostic medical devices (IVDs). These devices are critical for maintaining the smooth functioning of healthcare systems.
To achieve this, the regulation provides manufacturers and notified bodies with additional time to perform conformity assessments under the IVDR for IVDs covered by certificates or declarations of conformity issued in accordance with Directive 98/79/EC. This ensures a seamless transition without compromising the quality or safety requirements of IVDs. Detailed questions and answers related to this topic are addressed in a separate Q&A document.
2. Enhanced Communication on Disruptions in Device Supply
Under Regulation (EU) 2024/1860, manufacturers are now required to notify the relevant competent authorities and health institutions before interrupting or discontinuing the supply of certain medical devices or IVDs.
For situations where manufacturers do not supply devices directly to health institutions or healthcare professionals, they must ensure that the relevant economic operators in the supply chain are informed. These operators are then responsible for notifying health institutions. This communication mechanism enables competent authorities and health institutions to implement mitigation measures, thereby safeguarding patient health and safety. Further guidance on this obligation will be provided in another dedicated Q&A document.
3. Phased Rollout of EUDAMED Modules
One of the most significant updates in the amendment is the phased rollout of EUDAMED (European Database on Medical Devices). Instead of waiting for all six modules of the database to be finalized, the regulation permits the mandatory use of individual systems as they become operational.
This approach allows the immediate use of completed modules, such as those for registering economic operators, devices, and certificates. The gradual implementation is expected to enhance transparency and provide comprehensive information about medical devices available on the EU market. It will also aid in monitoring device availability, supporting effective oversight of the industry.
The newly published Q&A document specifically focuses on addressing questions related to this gradual EUDAMED rollout, ensuring stakeholders have the necessary guidance for compliance.
The Q&A document can be accessed using the following link
