IMDRF Meeting to Feature Update on EU Device Regs, FDA Initiatives
Ahead of this week’s meeting in Kyoto, Japan, members of the International Medical Device Regulators Forum have offered a sneak peek into what they will discuss during the event.
Scheduled for Sept. 14 to 18, the meeting will feature presentations from member states and industry organizations. The individual regulators have posted their presentations on IMDRF’s website, providing status updates on various initiatives.
The EU will provide an update on the medical device and in vitro diagnostic device regulations, which are expected to go to trialogue next month (). Topics slated for discussion among the European Parliament, European Commission and Council of Europe include premarket control of high-risk devices, reprocessing of single-use devices and counseling and informed consent for genetic tests.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, will update stakeholders on the center’s strategic priorities, providing an overview of key guidance documents issued over the past few months.
A representative from Brazil’s Agência Nacional de Vigilância Sanitária will discuss an agreement that grants it access to the Global Medical Device Nomenclature Agency’s database of accepted terms to identify medical devices. — Elizabeth Hollis