December 12, the EU commission called out to stakeholders for evidence regarding possible shortcomings of the MDR and IVDR. Proof regarding costs, the administrative burden, availabilty of devices, and the possible impact on the development of innovative devices are requested, This to support the evaluation of the efficacy of the MDR and IVDR. Consultation is open until March 21st 2025.
https://ec.europa.eu/newsroom/sante/newsletter-archives/58530