IMDRF advances three device guidelines for public consultation

The International Medical Device Regulators Forum (IMDRF) had recently forwarded three guidance documents with the purpose of providing integrated approach to the terminology and codes used in adverse event reporting, methodologies for analyzing registry data and the clinical evaluation of software as a medical device (SaMD). The three documents were given to the IMDRF management committee in Florianopolis, Brazil last month. They were cleared for public discussion by IMDRF members. The respective regulators will launch their own public discussions on the documents, as the US Food and Drug Administration (FDA) has already done for the SaMD document. The comments can be presented directly to the respective working group chairs. All three public discussions are set to close on 2 December 2016, with the assumption that the final versions will be presented to the IMDRF management committee in February 2017.