The European Commission continues to gather evidence of the impact of IVDR implementation, especially on manufactures plans to transition devices from IVD directive to IVD Regulation, or more importantly which devices manufacturers do not intend to transition. UK manufactures or subsidiaries who place product on the EU market including Northern Ireland are strongly encouraged to respond, noting that group companies should only make one submission.
The MedTech Europe update below provides the links.
Dear Members,
Within the framework of the IVD Regulation (IVDR) and Medical Devices Regulation (MDR), the European Commission continues to actively gather data via surveys to monitor the MDR and IVDR implementation.
One of these surveys, addressed to stakeholders (including industry) is being coordinated by GÖG (the Austrian National Public Health Institute) – the second (follow-up) survey’s official launch date is today (deadline for reply is 28 February 2025). For more information, please see the attached pdf document and below.
This follow-up survey will help to continue gather compelling evidence to concretely illustrate the challenges stakeholders encounter when implementing the IVDR and MDR. Of note: the survey also includes questions for the ongoing Targeted Evaluation of the MDR and IVDR (e.g. on recertification). It is therefore of great importance that you (and where applicable your members), participate to make sure regulators obtain the most realistic picture of the state of the IVDR and MDR implementation. MedTech Europe strongly encourages all members to reply to the survey.
Practical aspects:
- Reply to the survey here: https://ec.europa.eu/eusurvey/runner/2024MDAvailabilityMFARIMDBsurvey#
- Deadline for reply: 28 February 2025 (23:59 CET)
- Kindly provide only ONE answer per company
- GÖG will keep any company-specific information (raw data) collected strictly confidential and under no circumstances will disclose individualised company-level information. The aggregated, company-neutral data will be fed into a public dashboard and will be analysed in the form of synopsis reports.
- The results of the first survey are published in a public dashboard and in form of a PPT-presentation.
A webinar with the survey team from GÖG is organized on 16 January 2025 (11:00-12:00 CET) to answer questions – Zoom link: https://us02web.zoom.us/j/85384398029 (no need to register)
If you have any questions or enquiries in the meantime please contact medical.devices@goeg.at.
