Jeffrey K. Shapiro is presenting at the RAPS Webinar: Updates on Medical Device Post-Market Reporting Regulations

Medical device reporting


July 22, 2014

Jeffrey K. Shapiro will be speaking about Medical device reporting.

Medical device reporting is one of the most common post-market surveillance activities required of all medical device manufacturers in accordance with the Medical Device Reporting (MDR) regulation (21CFR 803). The FDA requires device companies to account for certain instances of adverse events and product problems in order to ensure safety issues can be identified and addressed quickly. The FDA recently revised MDR policies and published a final rule stating that manufacturers must submit MDRs in an electronic format, which is aimed at improving the FDAs process for collecting, reviewing, and archiving adverse event information. It is essential for device manufacturers to fully understand and prepare for these changes as the rule will go into effect on August 14, 2015.