IVDR Clinical Performance Study

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      

 Section 2 of Part A of Annex XIII

·       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

Click below link to know more about MDR Clinical Investigations :https://meddev-info.blogspot.com/2021/01/mdr-clinical-investigations.html

  Source: REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU