Manufacturers active in the European Economic Area (EEA), Switzerland and the U.K. must meet vigilance reporting requirements in order to stay on market and mitigate risks their products may pose to public health. However, subtle differences between vigilance regulations across the EU, Switzerland and the U.K. can complicate compliance efforts for companies large and small.
In this white paper, Emergo by UL regulatory experts explain European vigilance reporting requirements and challenges, including:
Identifying which incidents involving a manufacturer’s medical device require reporting to competent authorities, as well as associated timeframes and procedures to follow
Regulatory frameworks such as the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) for vigilance reporting in EEA markets, Switzerland and the U.K.
Vigilance reporting guidance specific to certain types of medical devices and product
Vigilance Reporting in the European Economic Area, Switzerland and the United Kingdom
2.26 MB
Download our white paper to learn more about Emergo by UL regulatory services to support medical device compliance to European vigilance reporting requirements.
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