IVDR Performance Evaluation

 The following listed GSPRs shall require scientific validity, analytical and clinical performance data providing sufficient clinical evidence.

•  Normal conditions of the intended use of the device (Performance characteristics Chapter I and Section 9 of Annex I)
• Evaluation of the interference(s) and cross-reaction(s)
•  Acceptability of the benefit-risk- ratio (Sections 1 and 8 of Annex I)

Medical device characteristics and its intended purpose shall determine the level of clinical evidence required to demonstrate the conformity with the relevant GSPRs. Level of clinical evidence need to specify and justified by the manufacturer.

Depth and extent of performance evaluation shall be based on,

·       Device characteristics including the risks

·       Risk class

·       Performance and its intended purpose

Performance evaluation is one of the general obligations of manufacturers (Article 10). performance evaluation is conducted per Article 56 and Part A of Annex VIII.

Performance evaluation definition per MDR is given below.

‘performance evaluation’ means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device;

Performance evaluation shall follow a defined and methodologically sound procedure for the demonstration of the following,

(a) scientific validity;

(b) analytical performance;

(c) clinical performance.

 Data and conclusions drawn from the assessment of those elements shall constitute the clinical evidence for the device.

 Clinical performance studies shall be carried out unless it is duly justified to rely on other sources of clinical performance data.

 Performance evaluation plan:

To plan, continuously conduct and document a performance evaluation, the manufacturer shall establish and update a performance evaluation plan

Plan shall include the below points, justification shall be provided in the plan if any points are not applicable 

Contents

intended purpose of the device;

Device characteristics

Analyte or marker to be determined by the device;

Intended use of the device

Reference materials or reference measurement procedures

Target patient groups with clear indications, limitations and contra- indications

Applicable general safety and performance requirements

Specification of methods

Description of the state of the art, including an identification of existing relevant standards, CS, guidance or best practices documents

Software qualified as a device, an identification and specification of reference databases and other sources of data used as the basis for its decision making

an indication and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the intended purpose or purposes and for the analytical and clinical performance of the device

POST-MARKET PERFORMANCE FOLLOW-UP (PMPF) planning

  Performance evaluation stages are given below, 

MDR Performance Evaluation

Identify through a systematic scientific literature review the available data relevant to the device and its intended purpose and identify any remaining unaddressed issues or gaps in the data;

Appraise all relevant data by evaluating their suitability for establishing the safety and performance of the device;

Generate any new or additional data necessary to address outstanding issues

 Scientific validity is demonstrated using below sources and documented in scientific validity report.

 — relevant information on the scientific validity of devices measuring the same analyte or marker;

— scientific (peer-reviewed) literature;

— consensus expert opinions/positions from relevant professional associations;

 — results from proof of concept studies;

— results from clinical performance studies.

analytical performance is demonstrated on the basis of analytical performance studies and documented in analytical performance report

 clinical performance is demonstrated using below sources and documented in clinical performance report

—clinical performance studies;

— scientific peer-reviewed literature;

— published experience gained by routine diagnostic testing

Scientific validity, analytical and clinical performance data constitute a clinical evidence for the device

 Performance evaluation report

It shall include the scientific validity report, the analytical performance report, the clinical performance report and an assessment of those reports

Contents

justification for the approach taken to gather the clinical evidence

literature search methodology and the literature search protocol and literature search report of a literature review

technology on which the device is based, the intended purpose of the device and any claims made about the device's performance or safety

nature and extent of the scientific validity and the analytical and clinical performance data that has been evaluated

clinical evidence as the acceptable performances against the state of the art in medicine

any new conclusions derived from PMPF reports

  

Frequency of Performance evaluation updates

MDR provides the timelines for class III & implantable devices. CER shall have a justification for frequency of update

It shall be updated throughout the life cycle of the device using clinical data obtained from the post market performance follow-up (PMPF)

 

Class	Timelines
class C and D devices	Shall be updated when necessary, but at least annually
Class A and B devices	When required based on PMS timelines

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

References:

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