IMDRF publishes guideline to improve accuracy and capture of medical device adverse events

On the 10thApril 2017, the International Medical Device Regulators Forum (IMDRF), a voluntary global team of medical device regulators, released a 14-page guideline detailing IMDRF terms, definitions and alpha-numerical codes to be used for pre- and post-market adverse event reporting for medical devices and in vitro diagnostics.

It is expected that widespread use of defined terms as well as associated codes to describe problems encountered with medical devices will improve the accuracy of capturing and reporting of medical device-related adverse events. For manufacturers (including local distributors/authorised representatives), the guideline provides consistency for reporting to multiple jurisdictions, reducing the burden of managing multiple coding systems. For regulatory authorities, the common terms and definitions should support the analysis of safety, quality assurance and performance information in a manner that can readily be shared globally, enabling a faster response by both regulatory agencies and device manufacturers.  In theory, patients and healthcare providers should expect faster local and international response to medical device adverse events.

Regulis views this guidelines as a key tool in aiding the collection and processing of medical device adverse events, and one which is expected to benefit all parties involved in the process.

To access the IMDRF website and download the guideline, click here.