IMDRF Sets New Long-Term Priorities on Pre-Market Review, Post-Market Surveillance of Devices

Posted 16 October 2015 By Zachary Brennan

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The International Medical Device Regulators Forum (IMDRF) says its focus over the next four years will be to hone in on the convergence of regulations across jurisdictions, and in supporting innovation and timely access to safe and effective medical devices, according to a strategic plan unveiled earlier this month.

The forum's management committee has also identified two new areas where it plans to focus its work: enhancing post-market surveillance and improving the effectiveness and efficiency of pre-market review.

"The focus is in areas where the lack of common regulatory requirements and practice may delay the delivery of medical devices of public health importance already available in one jurisdiction to the patients in other jurisdictions," IMDRF says.

The group, which is comprised of medical device regulators from Australia, Brazil, Canada, China, EU, Japan, the US and the World Health Organization, is looking to strike the right balance between pre-market and post-market regulatory requirements, particularly on data collection, and how to address these as part of a total product lifecycle regulatory approach.

Pre-Market Review

IMDRF may look to support the market entry of safe and effective devices that have been approved in other jurisdictions.

"Regulatory convergence also supports more timely market entry of safe and effective devices across member jurisdictions by facilitating reliance on data developed for and/or decisions made by one or more jurisdictions to support market approval in other jurisdictions," IMDRF adds.

And through the early-stage development of regulatory product submissions, including the establishment of a Table of Contents for non-IVD market authorization and IVD market authorization, IMDRF says its management committee has taken an early lead on pre-market review reforms.

New work items linked to pre-market review may also deal with assuring the reliability of data submitted to regulators, improving the quantity and quality of clinical data, developing harmonized review practices for premarket reviews/evaluations which includes competence and training for pre-market reviewers, developing guidance on benefit-risk determinations, and improving the suitability of international regulator standards and effective regulatory authority involvement at each stage in standards development.

Post-Market Surveillance

On the post-market surveillance end, IMDRF says it will build on its previous work there, particularly around improving the exchange of post-market data, harmonizing adverse event terminology across its jurisdictions, establishing a single audit program for devices and developing non-binding rules around unique device identifiers that could ease the tracking of devices.

Call for Suggestions

As far as the direction laid out by IMDRF, the management committee is also encouraging stakeholders to recommend new work items and to submit proposals on critical areas to address these strategic priorities.

The forum has met seven times since its inception in 2011, and most recently in Japan in September.

IMDRF Final Strategic Plan

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Categories: Medical Devices, Clinical, Compliance, Postmarket surveillance, Research and development, Regulatory strategy, Regulatory intelligence, News, US, Canada, Europe, Asia, IMDRF

Tags: IMDRF, medical device regulations, regulatory convergence, IVD

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