Performance Evaluation Plan is one of the key requirements according to IVDR 2017/746 and it is useful to define the clinical evidence needed to support the safe use of an In-vitro Diagnostic Device.
As you may know, the In-vitro Diagnostic Regulation (IVDR 2017/746) will be up and running starting from May 2022.
The introduction of the IVDR will have a huge impact on the in-vitro diagnostic sector and more than 80% all the IVDs aiming at obtaining a CE marking certification will need to have their technical dossiers reviewed by a Notified Body, along with an audit to check the compliance of the Quality Management System with Article 10 of the IVD Regulation 2017/746. This represents a huge change, as currently the majority of the IVD devices are self-certified by the manufacturer, with no involvement of the notified body.
We have been already discussing about the main new requirements related to IVDR regulation, the new classification systems and specific ISO standards related to in-vitro diagnostic device such as ISO 20916, ISO 23640 and ISO 18113.
In this article we will go through the requirements of the Performance Evaluation Plan for IVD Medical Devices.
The contents of a Performance Evaluation Plan
The requirements for the Performance Evaluation Plan are described within Annex XIII of EU IVDR 2017/746. In particular, the Performance Evaluation Plan shall include at least the following items:
- a specification of the intended purpose of the device;
- a specification of the characteristics of the device as described in Section 9 of Chapter II of Annex I and in point (c) of Section 20.4.1. of Chapter III of Annex I;
- a specification of the analyte or marker to be determined by the device;
- a specification of the intended use of the device;
- identification of certified reference materials or reference measurement procedures to allow for metrological traceability;
- clear identification of specified target patient groups with clear indications, limitations and contra-indications;
- an identification of the general safety and performance requirements as laid down in Sections 1 to 9 of Annex I that require support from relevant scientific validity and analytical and clinical performance data;
- a specification of methods, including the appropriate statistical tools, used for the examination of the analytical and clinical performance of the device and of the limitations of the device and information provided by it;
- a description of the state of the art, including an identification of existing relevant standards, CS, guidance or best practices documents;
- 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;
- or 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 outline of the different development phases including the sequence and means of determination of the scientific validity, the analytical and clinical performance, including an indication of milestones and a description of potential acceptance criteria;
- the PMPF planning as referred to in Part B of this Annex.
Performance Evaluation Plan in Summary
In summary, we can say that the performance evaluation plan is a document aimed at specifying the characteristics and performance of the IVD medical device; moreover, this document shall define the criteria for the generation of clinical evidence.
The Performance Evaluation Plan is part of the technical documentation and it shall be submitted for review to the notified body.
This is a living documents start shall be continuously updated through the implementation of the post market surveillance (PMS) and the post market performance follow up (PMPF).
Useful Guidance for Performance Evaluation Plan Preparation
There are multiple guidance documents that provide information that may be useful to prepare a Performance Evaluation Plan fully aligned with regulatory compliance:
- GHTF/SG5/N6:2012 – Clinical Evidence for IVD medical devices – Key Definitions and Concepts
- GHTF/SG5/N7:2012 – Clinical Evidence for IVD medical devices – Scientific Validity Determination
and Performance Evaluation - GHTF/SG5/N8:2012 – Clinical Evidence for IVD Medical Devices – Clinical Performance Studies for
In Vitro Diagnostic Medical Devices
Performance Evaluation Plan Template
QualityMeddev has made available a Performance Evaluation Plan Template, fully aligned with the requirements set in Annex XIII ofEU IVDR 2017/746. This is a 14-pages word document, fully editable, with a lot of comments and suggestions on how to properly amend the template in order to include the data related to your device and adequately fulfil the requirements of the EU IVDR.
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