News Category: Regulatory news
The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) has commissioned a study on supporting the monitoring of availability of medical devices on the EU market.
This is an important study as the data gathered will help identify challenges affecting device availability. The study may also give potential solutions to challenges for device availability in the EU.
The study started in December 2022 and will be running for 36 months up to December 2025.
The study has been contracted to a consortium led by the Austrian National Public Health Institute, in collaboration with Areté and Civic Consulting. The contractor has developed a one page summary of the study.
As part of the contractor’s data gathering activities, manufacturers and authorised representatives are being consulted to take part in surveys and interviews.
The first online survey for manufacturers and authorised representatives was published on 1 December. The survey will help to monitor the progress of the transition status of devices to MDR and IVDR.
The consultants held an information session on the survey on 7 December. The recording of the session is available on the consultant’s website.
The HPRA is encouraging all manufacturers and authorised representatives to take part in this survey. The deadline for feedback has been extended to 31 January 2024.