Posted 06 March 2017
By Zachary Brennan
Members of the International Medical Device Regulators Forum (IMDRF) will meet next week in Vancouver for the group’s 11th meeting. Presentations on updates from members located in the US, EU, Brazil, Australia, as well as updates on IMDRF working groups were unveiled recently.
For the EU’s latest update, Erik Hansson from the European Commission will discuss the new regulations for medical devices and in vitro diagnostics (IVDs). Voting on the texts is expected this month.
According to Hansson’s slides, the main features of the new texts include:
- Stricter premarket controls of high-risk devices;
- Reinforced criteria for designating and overseeing notified body processes;
- The introduction of a new risk-based classification system for IVDs;
- A new EU-wide requirement for an “implant card” to be given to patients receiving implanted devices;
- New requirements for manufacturers to collect and analyze real-world data for devices;
- A new Unique Device Identification system.
For the US update, the US Food and Drug Administration’s Center for Devices and Radiological Health Director Jeff Shuren will discuss final guidance on device accessories, final guidance on postmarket management of cybersecurity and final guidance on factors to consider regarding benefit-risk.
Shuren’s presentation will also touch on the fourth reauthorization of the Medical Device User Fee Act (MDUFA IV) and provisions in the 21st Century Cures Act that will impact device manufacturers.
Slides from other presentations from Brazil’s ANVISA, Australia’s TGA, Japan, Singapore, WHO and working group updates on software as a medical device, the national competent authority report exchange program, regulated product submissions and a new work item proposal for an application guide for unique device identifiers are also available on the upcoming meetings section of the IMDRF website.