International Medical Device Regulators Forum Discussion Paper
Medical device regulation in general is not as harmonized as drug and biologics regulation. This is true for pharmacovigilance in the Medical Device world. However, the International Medical Device Regulators Forum (IMDRF; see: http://www.imdrf.org/about/about.asp (Links to an external site.)) was formed in October 2011 to play a role in the Medical Device world that is similar to the role played by the ICH for drugs and biologics.
Take some time to explore the IMDRF website and describe the IMDRF membership. Which countries are represented? Where do the members come from (e.g. Industry? Regulatory Bodies?)? What are some of the safety/pharmacovigilance-relevant closed and/or current “work items” in the Medical Device harmonization space? How do these work items compare with the overall PVG harmonization themes of the drugs/biologics world? What are your thoughts about these initiatives?
