On the Consultation Process Regarding EU Medical Device Legislation

Dear Members,

In the correspondence forwarded to our Union by the Ministry of Trade, it is stated that the European Commission has conducted a consultation process regarding the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which were adopted in 2017. Following the evaluations obtained during the consultation process, the Commission has published a draft Regulation proposal along with an evaluation report, its summary, and working documents.

In this context, detailed information regarding the feedback process for the draft Regulation can be accessed via the link below, and opinions can be submitted between 7 January and 11 March 2026. https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vi tro-diagnostics-targeted-revision-of-EU-rules_en

We kindly request that opinions be forwarded to (irem.ardic@tobb.org.tr).