The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to strategically accelerate
international medical device regulatory convergence.
As indicated in the IMDRF Terms of Reference (ToR), IMDRF activities and initiatives may fall into several categories, one of which being technical documents created to address technical matters relating to the regulation of medical devices. The process for developing technical documents is described in the IMDRF Standard Operating Procedure (SOP) and includes seven stages. The last stage of development is implementation, which is at the discretion of each regulatory authority responsible for medical devices in the area. Each regulatory authority may need at least one year to implement a document after publication in final.
The implementation levels are defined in the IMDRF SOP and repeated below for ease of reference.
Implemented: All relevant elements, concepts and principles of the IMDRF document are followed.
Partly implemented: The IMDRF document has been implemented in a modified way that
a) does not include all relevant elements, concepts and principles of the IMDRF document or
b) requires application of the document for a smaller range of products than outlined in the IMDRF document.
Not applicable: The implementation of a specific IMDRF document is not applicable in a country/region.
Not implemented: The process for the implementation of the IMDRF document has not yet started or is not completed.
This document provides a report on the status of implementation of all IMDRF technical documents as self-identified by IMDRF members as of the date of publication. In addition to overseeing IMDRF documents, the IMDRF Management Committee also oversees documents previously published by the
GHTF. While the implantation status of GHTF documents is not included in this report, these documents are important foundational tools and continue to be managed by the IMDRF.