Medical Devices SECTION EDITOR

●
✒ Namrata Upadhyay
nupadhyay@md-clinicals.com

Clinical investigation for medical devices –

types and stages
Annex I of ISO 14155:2020 (International Organization for
Standardization) helps define the various stages of clinical
ANNEX 1 - ISO 14155:2020
investigations for medical devices as well as the types of study
designs. The following flowchart summarises Annex I, to assist
Medical Device Clinical Investigation (CI) stages
those working in this domain, to
better understand what each type of
clinical investigation (CI) entails
t
and facilitate with the medical
Pre-Market Post-Market
device study designing process. Clinical Clinical
Investigation Investigation

A CI done after market approval of a

t t
medical device
Pilot Stage Pivotal Stage

Intended to answer specific questions to

device performance, effectiveness and
safety
A confirmatory CI designed to collect
An exploratory clinical investigation
data on clinical performance, Post market CI can be a part of post-
effectiveness or safety of a device market clinical follow up (PMCF)
Used to capture preliminary
information on medical devices at an
Done in a statistically justified Note: if a marketed device is investigated
early stage of product design,
number of subjects for new indications other than those
development and validation
described in its labelling, then the
May or may not be preceded by an requirements for a pre-market CI apply
Might not require pre-specified
early and/or late traditional feasibility
statistical hypotheses but design of
study
this CI and its outcomes can be more
straightforward if statistical
u u
considerations are provided
Types of Study Design
Helps plan further steps of design
development
Exploratory Confirmatory Observational
for example
First in Human or Early An adequate controlled CI Draw inference of
Need for design modifications feasibility CI are exploratory possible effect of an
Hypothesis of primary endpoint intervention on subjects
Parameters for pivotal CI Might not have a pre-specified are stated in the CIP before the but no subjects are
statistical hypotheses start of the CI assigned to intervention
groups. Only data during
Can be conducted to generate Sound confirmative statistical the normal course or
a hypotheses which is testing is applied clinical practice is
u confirmed in subsequent CI collected.

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 t t
First in Human (FIH) CI
Proof-of-Concept CI
Medical device is
evaluated for the first
time in humans
u
Burden to Subjects
Interventional CI
l A pre- or post-market CI
l Assignment of subject to
a medical device is
decided in advance in a
Clinical Investigation
Plan (CIP)
l Diagnostic or monitoring
procedures to collect
data on S&P of device
are pre-specified in a CIP
in addition to those used
in a normal clinical
practice
Non-Interventional CI
l A post-market CI where
the medical device is
used according to
labelling
l Assignment of subject is
not decided in advance
but falls under current
clinical practice
l No diagnostic/
monitoring procedure
defined
l Epidemiological methods
used to collect data
u clinical use)
www.emwa.org
t
Early Feasibility CI Traditional Feasibility CI
or
This is a limited CI of a device early A CI commonly used to capture
in its development preliminary performance,
effectiveness or safety information
t Done when the medical device is
before the device design near-final or final device design
is finalised
Done to plan an appropriate Pivotal CI
Medical device has a specific
indication More non-clinical or prior clinical data
is expected for this CI
for example
because
innovative device for new/
t
established technology
the near final design takes
Marketing device for novel place later in development
clinical application than an early feasibility CI
This CI does not need to be preceded
Done to evaluate device design by an early feasibility CI
concept with regards to clinical
safely, performance and
effectiveness
u
Done in a small number of subjects
Done when the informaton can’t
be provided by non-clinical
assessment or when the non-
clinical tests are unavailable
Information gathered in this study
can guide device modification
An early feasibility CI does not
necessarily involve the first clinical
use of the device
which means
t
We could have, for example,
compassionate use studies prior
to the early feasibility study (first
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