In April 2017, the European Parliament and the Council adopted the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746. These two Regulations aim to create a robust, transparent,...
Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices (as per Article 10a of Regulation (EU) 2024/1860 amending Regulation (EU) 2017/745 and Regulation (EU)...
The Commission has launched a public consultation and a call for evidence on the EU’s legislation on medical devices and in vitro diagnostic medical devices, as part of the targeted evaluation of these rules. The...
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes the requirements for notified bodies involved in the conformity assessment of applicable classes of in vitro diagnostic medical devices (IVDs). Manufacturers must demonstrate that...
The aim of the study from 2 December 2022 to 1 December 2025 is to support monitoring and analyzing the availability of medical devices on the EU market in the context of the implementation of...
This scientific view reflects the opinion of independent experts (MDR Article 106.1) on the performance evaluation report (PER) of the manufacturer. The advice is provided in the context of the performance evaluation consultation procedure (PECP),...
The European Commission’s Directorate-General for Health and Food Safety – through the European Health and Digital Executive Agency – has commissioned a “Study supporting the monitoring of availability of medical devices on the EU market....
HaDEA has published the EU4Health call for tenders HADEA/2024/OP/0024- horizon scanning for medical devices & in vitro diagnostic medical devices. The call aims to purchase horizon scanning in the area of medical devices and in vitro diagnostic medical devices...
The document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices....
Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards...
