the total description on the ISO guideline 14415:2016 The overview to medical devices and ivds

1. CLINICAL INVESTIGATION
AND EVALUATION OF
MEDICAL DEVICES AND IVD
PREPARED BY : REECHA SHAH
Masters of pharmacy regulatory affairs

2. CONTENTS
◦ DEFINITIONS
1. MEDICAL DEVICES 2. IVDs
◦ CLASSIFICATION
1. MEDICAL DEVICES 2. IVDs
◦ CLINICAL INVESTIGATION OF MEDICAL DEVICES AND IVDs
◦ WHEN IS THE CLINICAL INVESTIGATION NEEDED
◦ FINAL STUDY REPORT
◦ ETHICAL CONSIDERATIONS
◦ CLINICAL EVALUATION OF MEDICAL DEVICES AND IVDs
◦ WHEN AND WHY IT IS UNDERTAKEN
◦ CLINICAL RESEARCH REPORT.

3. DEFINITIONS
1)MEDICAL DEVICES
◦ As per USFDA,
◦ It can be found in Section 201(h) of the
Federal Food, Drug, and Cosmetic Act.
◦ It basically says a medical device is “any
instrument, machine, contrivance, implant,
in vitro reagent that's intended to treat, cure,
prevent, mitigate, diagnose disease in man”.
◦ Some examples could be a simple tongue
depressor, or a thermometer, all the way to
an advanced robotic surgical device.
◦ As per D&C Act,
◦ Instrument intended for internal or external use
in the prevention of disease or disorder in
human being or animal as may be specified from
time to time by central government by
notification in the official gazette, after
consultation with the board.
◦ For example bandages , surgical dressings ,
contraceptives etc.
References : https://www.fda.gov/
https://cdsco.gov.in/opencms/opencms/en/Acts-Rules/

4. DEFINITION
2) In Vitro Diagnostics (IVDs)
◦ AS PER USFDA,
◦ In vitro diagnostic products are those reagents, instruments, and systems intended for use in
diagnosis of disease or other conditions, including a determination of the state of health, in order
to cure, mitigate, treat, or prevent disease or its sequelae.
◦ For example self test kits for pregnancy etc.
References : https://www.fda.gov/
https://cdsco.gov.in/opencms/opencms/en/Acts-Rules

5. CLASSIFICATION
1) MEDICAL DEVICES
◦ AS PER USFDA,
Classification Risk level Example
Class 1 Low risk Adhesive bandages, Hospital
beds
Class 2 Medium risk also known as
‘general controls and special
controls’
Blood pressure cuffs, Sutures
Class 3 High risk Pacemaker, vascular graft
References: https://www.fda.gov/

6. CLASSIFICATION
1)MEDICAL DEVICES
◦ AS PER D & C ACT,
CLASSIFICATION RISK LEVEL Examples
CLASS A Low risk Thermometers, tongue
depressors,
CLASS B Low moderate risk Hypodermic needles,
Suction equipment
CLASS C Moderate high risk Lung Ventilator, Bone
Fixation Plate
CLASS D High risk Heart valves, pacemaker,
Implantable defibrillator
References: https://cdsco.gov.in/opencms/opencms/en/Acts-Rules/

7. CLASSIFICATION
2)In Vitro Diagnostics (IVDs)
CLASSIFICATION RISK LEVEL
CLASS 1 Low to moderate risk
CLASS 2 Moderate to high risk
CLASS 3 High risk
References: https://www.fda.gov/

8. CLINICAL INVESTIGATION OF
MEDICAL DEVICES AND IVDs
◦ A clinical investigation is defined as any systematic investigation or study in or on one or more
human subjects, undertaken to assess the safety, clinical performance and/or effectiveness of a
medical device and IVDs.
◦ The undertaking of a clinical investigation is a scientific process that represents one method of
generating clinical data.
◦ The objective of a clinical investigation is to assess the safety, clinical performance and/or
effectiveness of a medical device and IVDs for a particular indication or intended use.
◦ The general requirements of the clinical investigation of medical devices is given under ISO
14155:2011
References: clinicalinvestigationandevaluationofmedicaldevicesand-
230117161600-fef779bb.pdf

9. WHEN IS THE CLINICAL
INVESTIGATION NEEDED?
◦ Clinical investigations are necessary to provide data not available through other
sources (such as literature or nonclinical testing).
◦ When considering the need for a clinical investigation, one should consider
whether there are new questions of safety, clinical performance and/or
effectiveness for the particular medical device and intended use that need to be
addressed in a clinical investigation.
References : clinicalinvestigationandevaluationofmedicaldevicesand-230117161600-fef779bb.pdf

10. Refenrences: https://www.fda.gov/

11. FINAL STUDY REPORT
◦ The outcome of a clinical investigation should be documented in a final study
report.
◦ This then forms part of the clinical data that is included in the clinical evaluation
process and ultimately becomes integrated into the clinical evaluation report
References: clinicalinvestigationandevaluationofmedicaldevicesand-230117161600-
fef779bb.pdf

12. Ethical consideration for conducting
investigation
It should generate new data and answer specific safety,
clinical performance, and effectiveness questions that
remain unanswered by the current body of knowledge.
The desire to protect human subjects from unnecessary
or inappropriate experimentation must be balanced with
the need to protect public health through the use of
clinical investigations where they are indicated.
References: clinicalinvestigationandevaluationofmedicaldevicesand-230117161600-fef779bb.pdf

13. Clinical Evaluation of Medical Devices
and IVDs
◦ Clinical evaluation is a set of ongoing activities that use scientifically sound
methods for the assessment and analysis of clinical data to verify the safety,
clinical performance and/or effectiveness of the medical device when used as
intended by the manufacturer.
References: clinicalinvestigationandevaluationofmedicaldevicesand-230117161600-fef779bb.pdf

14. WHEN AND WHY CLINICAL
EVALUATION IS UNDERTAKEN
◦ WHEN
◦ It is first performed during the development
of a medical device in order to identify data
that need to be generated for regulatory
purposes and will inform if a new device
clinical investigation is necessary, together with
the outcomes which need to be studied.
◦ This information is fed into the ongoing risk
management process (according to ISO
14971:2007) and may result in changes to the
manufacturer's risk assessment, clinical
investigation documents, Instructions for Use
and post market activities.
◦ WHY
◦ When placing a medical device on the market, the
manufacturer must have demonstrated through the
use of appropriate conformity assessment
procedures that the medical device complies with
the Essential Principles of Safety and Performance
of Medical Devices.
◦ Generally, it is expected that the manufacturer has
demonstrated the medical device achieves its
intended performance during use according to its
labelling (i.e. information supplied by the
manufacturer) and that the known and foreseeable
risks are minimized and acceptable when weighed
against the benefits.
References: clinicalinvestigationandevaluationofmedicaldevicesand-230117161600-fef779bb.pdf

15. FOR MEDICAL
DEVICES
◦ STAGE 1 DATA IDENTIFICATION
◦ STAGE 2 APPRAISAL OF CLINICAL DATA
◦ STAGE 3 ANALYSIS OF CLINICAL DATA
References:
clinicalinvestigationandevaluationofmedicaldevices
and-230117161600-fef779bb.pdf

16. FOR IVDs
Create and review
the SOP
Device specific
performance
evaluation plan
Conduct the
analytical
performance
evaluation
Conduct the clinical
performance
evaluation
Demonstrate the
stability of IVD
Reports of the
clinical
performance
evaluation
Create and
implement PMPF
Refenrences: https://www.fda.gov/

17. CLINICAL RESEARCH REPORT
◦ At the completion of the clinical evaluation process a report should be compiled
that outlines the scope and context of the evaluation; the inputs (clinical data).
◦ The appraisal and analysis stages; and conclusions about the safety and
performance of the device in question.
◦ The clinical evaluation report should contain sufficient information to be read as
a stand alone document by an independent party (e.g. regulatory authority or
notified body).
◦ The technology on which the medical device is based, the intended use of the
device and any claims made about the device’s clinical performance or safety
◦ The nature and extent of the clinical data that has been evaluated.
References: clinicalinvestigationandevaluationofmedicaldevicesand-230117161600-fef779bb.pdf