Outreach Letter to Health Ministers - Medical Devices and In Vitro Diagnostics Regulations (MDR/IVDR)

As part of our continued advocacy on regulatory and non-regulatory files at the EU level, our latest understanding is that Denmark may actively support targeted measures focusing on recertification. Additionally, we have learned the Polish Competent Authorities have reached out to their Ministry of Health to include the MDR on the agenda of the June EPSCO meeting, alongside the GPL. They reportedly referenced a list of proposed solutions that were previously aligned with local notified bodies and industry stakeholders.

Considering these developments, we believe this presents another opportunity to demonstrate to Member States that the industry is supportive of target measures under the MDR/IVDR framework. In a similar manner to the GPL letter on RDP, we drafted a template letter which you can find below.