Module 19 2021

01/06/2021

Continues and expands on GHTF model, eg ● MDSAP ● Common Regulatory Submission ● Review of system for exchange of information on adverse events Expanded membership Has undertaken to maintain GHTF documents

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In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) IMDRF/RPS WG/N13 FINAL:2018 (Edition 2) Use of the ToC formats will facilitate filing medical device applications for multiple jurisdictions and promote timely international access. It will also support the transition to a Health Level-7 (HL7) electronic environment. ● HL7 is a messaging standard that supports submission of information for regulated products. ● Each HL7 message includes the contents of a regulatory submission plus metadata that communicates the structure of the content and aids in electronic processing of submissions. HC requirement for Class III and IV devices as of April 2019

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