The International Medical Device Regulators Forum (IMDRF) proposed updates on Wednesday to clinical evaluation documents in support of rapid market entry across multiple jurisdictions.
The IMDRF’s medical devices clinical evidence working group (MDCE WG) re-issued consultations Wednesday to propose updates to three Global Harmonization Task Force (GHTF) documents from 2007 and 2010.
The MDCE WG’s consultation documents seek to reflect the recently implemented and/or forthcoming regulatory requirements in the IMDRF member countries for demonstrating equivalence between a proposed device and a comparable device for regulatory clinical evaluation using overseas clinical data.
The IMDRF member regulators intend to better facilitate the simultaneous or sequential introduction of medical devices into markets across various jurisdictions through the newly harmonized documents on clinical evaluation. As such, there is a greater focus on device comparability.
“While conducting clinical evaluation through the clinical data of comparable device, the demonstration of equivalence between device under application and comparable device is one of the critical steps,” the MDCE WG explained. “The existing GHTF clinical evaluation document focus on the source, appraisal, and analysis of clinical data, without adequate descriptions for the equivalence demonstration.”
The work involves two GHTF documents from 2007 on clinical evidence key definitions and concepts as well as clinical evaluation and an additional GHTF document from 2010 on clinical investigations.
Previously harmonized definitions were slightly revised, but clinical evaluation was almost entirely revised. IMDRF proposes defining clinical evaluation as: “A set of ongoing activities that use scientifically sound methods for the assessment and analysis of clinical data to verify the safety, clinical performance, and/or effectiveness of the device when used as intended by the manufacturer.”
The revised GHTF clinical evaluation document proposes more updates compared to the other two relevant documents, though it is also the most extensive. Updates in this document relate to when clinical evaluation is performed, definitions and general principles, among other sections. They include new general principles on software as a medical device and clinical trial registries as sources of data for use in clinical evaluations. There is also an entirely new appendix on comparability considerations.
Proposed updates to the GHTF document on clinical investigations mostly fall under general principles and ethical considerations. Several redactions to all three GHTF documents are proposed as well.
Other documents the MDCE WG will use to inform its work include technical guidelines from China’s National Medical Products Administration, guidelines of the EU’s current medical device directive and annexes under its forthcoming medical device regulation, as well as US Food and Drug Administration draft guidance from 2015 on the acceptance of overseas medical device clinical data (that was withdrawn
by FDA in 2018).
The group proposed the new consultation documents after submitting draft versions to the IMDRF management committee (MC) during the meeting last month. The MC also granted
approval to China’s first
IMDRF new work item proposal (NWIP) last year. The WG plans to submit final documents to the MC in September. The March meeting also resulted in a final
assembly and technical guide on building submissions using the Table of Contents structure and standard development organizations NWIP