International Medical Device Regulators Forum Latest Updates of January – March 2017
Outcome statement of the IMDRF-11 management committee – Vancouver Meeting outcome – 14 – 16 March 2017
The eleventh meeting of the Management Committee (MC) of the International Medical Device Regulators Forum (IMDRF) took place in Vancouver, Canada, from 14 to 16 March 2017. The MC consists of regulators from Australia, Brazil, Canada, China, the European Union (EU), Japan, the Russian Federation, Singapore and the United States of America (USA). Representatives of the World Health Organization (WHO) and the Asia-Pacific Economic Cooperation Life Sciences Innovation Forum Regulatory Harmonization Steering Committee (APEC LSIF RHSC) participated as Official Observers and Asian Harmonization Working Party (AHWP) and Pan American Health Organization (PAHO) participated as Affiliate Organizations.
On the first day, progress achieved on current work was discussed.
On the second day, an open Stakeholder Forum was held. The Forum included around 150 participants representing regulators, industry, and the research community. In the morning, participants had an opportunity to hear regulatory updates from Australia, Brazil, Canada, China, EU, Japan, Russia, Singapore and USA and update reports on IMDRF’s current work items.
On third day Management committee took an overview on current work and progress achieved and then approved some final documents relating to the adverse event reporting and also approved data exchange guidelines.
Methodological Principles in the Use of International Medical Device Registry Data – March 16, 2017
The International Medical Device Regulators Forum (IMDRF) Registry Working Group was created with the purpose of developing:
- Essential principles for linking electronic patient, device and outcome registries and/or related data repositories or identifiers such as Unique Device Identifiers (UDIs), including the principles behind data access, security, informatics formats, governance and other key areas related to global regulatory applications for medical device evaluation.
- Essential principles related to optimal methodologies for analysis of heterogeneous data sources applied to medical device safety signal detection, performance and reliability.
This document focuses on the task described in Second point. The document leverages the essential principles behind data access, security, informatics formats and other key areas related to global applications for medical device information described in first point. It applies the medical device registry definition and introduces the methodological concept of international Coordinated Registry Networks (iCRNs) to maximize the potential of data captured in the international registries.
Competence, Training, and Conduct Requirements for Regulatory Reviewers – March 16, 2017
This IMDRF Good Regulatory Review Practices document provides a common set of conduct, education, experience, competence, and training requirements that shall be established and maintained by the Regulatory Authorities and/or their recognized Conformity Assessment Bodies (CAB) for individuals who perform regulatory reviews of medical devices. Depending on individual legislations within various jurisdictions, additional requirements beyond those in this document may apply.
This document is intended to develop the consistency of regulatory reviews by Regulatory Authorities and/or their recognized CAB. Implementation of these practices is intended to provide an opportunity to rely on regulatory reviews performed by other Regulatory Authorities and/or their recognized CAB.
This document applies to individuals performing regulatory reviews and making decisions associated with the regulatory review for IVD and non IVD medical devices, on behalf of Regulatory Authorities and/or their recognized CABs. This document recognizes the use of Regulatory Reviewers and Technical Experts in the regulatory review process and provides separate training and competency requirements for each.
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes – March 16, 2017
This document has been prepared by the IMDRF Adverse Event Working Group, charged with developing a harmonized terminology for reporting adverse events related to medical devices including in-vitro diagnostics (IVDs).
Widespread use of a single, appropriate adverse event terminology and coding system is expected to improve signal detection by adverse event management systems enabling a faster response by both industry and regulatory agencies.
Use of defined terms as well as associated codes to describe problems encountered with medical devices provides several benefits:
- It improves the accuracy of capturing and reporting of medical device related adverse events;
- It reduces ambiguity and hence increases effectiveness of the evaluation process;
- It is readily usable, in contrast to narrative text, for more sophisticated approaches to signal detection (i.e. the identification of potential novel risks) and trending analysis by incident management systems including advanced querying functions and data visualization. Thus it enables a faster response by both regulatory agencies and device manufacturers.
Data Exchange Guidelines – Common Data Elements for Medical Device Identification – March 16, 2017
The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory convergence. It 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 (GHTF). The Forum will accelerate international medical device regulatory harmonization and convergence. Regulators require submission of device identification information at different points in the regulatory lifecycle of a medical device. Structured device identification information in standard electronic format is expected now or in the future which is to be included as part of pre-market submission, post-marketing distribution and use i.e. disposal and discard, adverse event/vigilance reporting, and corrective field actions (e.g., recall, advisory notices).
Once the medical device is commercially available, a Unique Device Identification (UDI) system is expected to capture the device identification data elements at the level of a particular medical device. However, at the point of initial regulatory submission, specific medical device identification data elements are not always assigned. Therefore it would be useful to establish common data elements which can be defined throughout the lifecycle. These data elements are not currently identified resulting in the lack of a consistent nomenclature, definitions and structure for submission of this identifying information. Each type of submission may reference the product differently.
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