Imdrf Proc 151002 Strategic Plan 2020
Imdrf Proc 151002 Strategic Plan 2020
Imdrf Proc 151002 Strategic Plan 2020
International Medical
IMDRF Device Regulators Forum
FINAL DOCUMENT
This document was produced by the International Medical Device Regulators Forum.
There are no restrictions on the reproduction or use of this document; however,
incorporation of this document, in part or in whole, into another document, or its
translation into languages oth~r than English, does not convey or represent an
endorsement of any kind by the Intemational Medical Device Regulators Forum.
I. Introduction
Three years have passed since the launch of IMDRF in 2012. In this early period, IMDRF
developed sound foundational procedures and governance arrangements. Also in this period
IMDRF has delivered a number of significant work products some of which are a continuation of
the Global Harmonization Task Force (GHTF).
IMDRF has now reached a juncture where it should define its strategic direction for the
coming years to better coordinate its activities and allocate its limited resources. The IMDRF
Strategic Plan 2020 sets out the strategic priorities of the forum from 2016 to 2020.
2. Strategic Priorities
The IMDRF ToR lists eight objectives to achieve our mission. While all objectives remain
important, the Management Committee (MC) intends to put particular focus on the objective,
“Support innovation and timely access to safe and effective medical devices” from 2016 to 2020.
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. The IMDRF strategic plan is expected to promote further
regulatory convergence among IMDRF members resulting in benefits for patients, healthcare
professionals and industry stakeholders. To assure that this objective is met in an efficient and
effective manner, the MC has identified the following strategic priorities for which it will
develop New Work Items and work plans:
In pursuing these strategic priorities, IMDRF would seek to assure an appropriate balance
between pre-market and post-market requirements as part of a total product lifecycle regulatory
approach to medical devices. Striking the right balance between pre-market and post-market
requirements, such as pre-market and post-market data collection, can facilitate timely patient
access to safe and effective devices by minimizing pre-market requirements to the extent
appropriate while assuring that patients receive safe and effective devices. This approach is
reflected in IMDRF's work item on Software as a Medical Device for which the framework
under development would foster the optimal use of applicable post-market controls to narrowly
tailor premarket requirements, as appropriate. IMDRF continues supporting the current work
items.
The MC encourages all the stakeholders to recommend NWIs or to submit New Work Item
Proposals that are critical for achieving these strategic priorities. IMDRF will undertake NWIs
depending on the extent to which the NWI will advance the strategic priority, the feasibility of
the NWI, and the availability of adequate resources to develop the proposed outputs. IMDRF
will still consider other NWIPs for other topic areas but is not likely to accept those proposals
unless there is a sufficiently compelling reason to do so.
iii) Harmonization of adverse event terminology to expand the terminology and systems
being used to code information relating to medical device adverse events;
iv) Establishment of a Medical Device Single Audit Program; and
v) Development of non-binding rules for creating, using, and maintaining unique device
identifiers and related activities.
From 2016 to 2020, the MC intends to build on the work already started or completed as well as
consider New Work Items in line with identified objectives.
b) To the extent feasible and appropriate, support training activities on IMDRF outputs
conducted by other organizations.
In addition, in the future when accepting NWIs or New Work Item Extensions, the MC will
develop work plans with timetables for completion of deliverables and make them available to
the public.