MDR Definitions:
‘performance study’ means a study undertaken to establish or confirm the analytical or clinical performance of a device;
‘analytical performance’ means the ability of a device to correctly detect or measure a particular analyte;
‘clinical
performance’ means the ability of a device to
yield results that are correlated with a particular clinical condition or a
physiological or pathological process or state in accordance with the target
population and intended user;
Clinical performance studies requirements are defined in article 57 to 76
and Section 2 of Part A of Annex XIII
·
Article 57 General requirements regarding performance studies
·
Article 58 Additional requirements for certain performance studies
· Article 59 Informed consent
· Article 60 Performance studies on
incapacitated subjects
· Article 61 Performance studies on
minors
·
Article 62 Performance studies on pregnant or breastfeeding women
· Article 63 Additional national
measures
·
Article 64 Performance studies in emergency situations
· Article 65 Damage compensation
· Article 66 Application for performance
studies
· Article 67 Assessment by Member
States
·
Article 68 Conduct of a performance study
·
Article 69 Electronic system on performance studies
·
Article 70 Performance studies regarding devices bearing the CE marking
·
Article 71 Substantial modifications to performance studies
·
Article 72 Corrective measures to be taken by Member States and information
exchange between Member States on performance studies
·
Article 73 Information from the sponsor at the end of a performance study or in the
event of a temporary halt or early termination
·
Article 74 Coordinated assessment procedure for performance studies
·
Article 75 Review of the coordinated assessment procedure
·
Article 76 Recording and reporting of adverse events that occur during performance
studies
·
Data
used to establish or confirm aspects of device performance which cannot
be determined by analytical performance studies, literature and/or previous
experience gained by routine diagnostic testing.
·
shall
be carried out in accordance with recognised ethical principles.
·
Studies
are e designed in such a way as to maximize the relevance of the data while
minimising potential bias
Clinical
performance study plan (CPSP)
Clinical performance studies
shall be performed in accordance with the Clinical performance study plan (CPSP)
·
CPSP shall define the below
o Rationale
o Objectives
o Design and proposed analysis
o Methodology
o Monitoring
o Conduct and
o Record-keeping
It shall contain the following information:
single identification number of the clinical performance study |
Sponsor/ legal representative ·
identification of
the sponsor/ legal representative ·
name ·
address of the
registered place of business ·
contact details |
information on the investigator or investigators ·
Principle /coordinating
or other investigator ·
Qualifications ·
contact details ·
investigation site
or sites, such as number, qualification, contact details ·
location and number
of lay persons involved (case of devices for self-testing) |
starting date and scheduled duration |
Device details ·
identification and
description of the device ·
its intended purpose ·
analyte or analytes
or marker or markers ·
metrological
traceability ·
manufacturer |
type of specimens used |
synopsis of the clinical performance study, ·
design type, such as
observational, interventional ·
objectives ·
hypotheses of the
study ·
reference to the
current state of the art in diagnosis and/or medicine |
Expected
risks and benefits of the device and of the clinical performance study in
the context of the state of the art in clinical practice |
·
instructions for use
of the device or test protocol, ·
training and
experience of the user ·
calibration procedures
and means of control, · indication of any other devices, medical devices, medicinal product or other articles to be included or excluded and the specifications on any comparator or comparative method used as reference |
Design of the clinical performance study ·
description of and
justification ·
scientific
robustness and validity, including the statistical design ·
details of measures
to be taken to minimise bias, such as randomisation ·
management of
potential confounding factors |
analytical performance |
parameters of clinical performance |
study population: specifications of the subjects selection criteria size of performance study population representativity of target population if applicable, information on vulnerable subjects involved, such as
children, pregnant women, immuno-compromised or elderly subjects |
information on use of data out of left-over specimens banks, genetic
or tissue banks, patient or disease registries etc. |
monitoring plan |
data management |
decision algorithms |
policy regarding any amendments |
accountability regarding the device ·
control of access to
the device ·
follow-up in
relation to the device used in the clinical performance study ·
return of unused,
expired or malfunctioning devices |
statement of compliance with the recognised ethical principles |
informed consent process, including a copy of the patient information
sheet and consent forms (not applicable for
studies using left-over samples) |
procedures for safety recording and reporting |
criteria and procedures for suspension or early termination |
procedures for follow up of subjects (not applicable for studies using left-over samples) |
procedures for communication of test results outside the study (not applicable for studies using left-over samples) |
policy as regards the establishment of the clinical performance study
report (not applicable for studies using left-over samples) |
Technical and functional features of the device indicating those that
are covered by the performance study |
bibliography |
Clinical
performance study report(CPSR)
·
Signed by a medical
practitioner or any other authorised person responsible
·
Transparent, free of
bias and clinically relevant
·
Include the clinical
performance study protocol plan, results and conclusions of the clinical
performance study, including negative findings
·
Any protocol
amendments or deviations, and data exclusions with the appropriate rationale
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