In vitro Diagnostics (IVD)
Performance Evaluation Plan (PEP)
To plan, continuously conduct, and document a performance evaluation,
the manufacturer must establish a performance evaluation plan (PEP).
The PEP defines the performance evaluation process and outlines key
parameters, taking into account the intended purpose and use of the IVD, the specification of the analyte to be determined, the target patient groups, clear indications, possible contraindications, and limitations. Additionally, the PEP should detail the intended methods and statistical tools used to evaluate the analytical and, if applicable, clinical performance of the IVD.
the manufacturer must establish a performance evaluation plan (PEP).
The PEP defines the performance evaluation process and outlines key
parameters, taking into account the intended purpose and use of the IVD, the specification of the analyte to be determined, the target patient groups, clear indications, possible contraindications, and limitations. Additionally, the PEP should detail the intended methods and statistical tools used to evaluate the analytical and, if applicable, clinical performance of the IVD.
Further Services
In vitro Diagnostics (IVD)
Which clinical study do I need for my product? Or do I need a clinical study at all?
What phase of the clinical life cycle is my product in? How extensive do the clinical data to
be collected need to be? You will find answers to these and other questions in this section.
What phase of the clinical life cycle is my product in? How extensive do the clinical data to
be collected need to be? You will find answers to these and other questions in this section.
Overview
In vitro Diagnostics (IVD)
Regardless of the risk class of your IVD product, our experienced team of scientists, engineers and physicians takes charge of your needs.
If you are in the process of obtaining CE marking for your IVD, we will identify previously collected data on your IVD for you and its clinical performance for its intended use.
Through targeted analysis and strategic consulting, we help you leverage existing evidence efficiently. This not only saves time but also strengthens your overall documentation.
If you are in the process of obtaining CE marking for your IVD, we will identify previously collected data on your IVD for you and its clinical performance for its intended use.
Through targeted analysis and strategic consulting, we help you leverage existing evidence efficiently. This not only saves time but also strengthens your overall documentation.
In vitro Diagnostics (IVD)
A state-of-the-art (SOTA) service goes beyond literature research. It provides insights into current treatment options for the condition the device addresses and how the new device improves treatment outcomes.
In vitro Diagnostics (IVD)
The performance evaluation report (PER) combines all elements of clinical evidence and constitutes the key document for the IVD´s performance evaluation. As far as beeing applicable, it should include the scientific validity report, analytical performance report, and clinical performance report, along with an assessment of these reports to demonstrate clinical evidence, including a justification for the chosen approaches. The PER is continuously updated – annually for Class C and D IVDs, and as needed for Class A and B IVDs, based on new clinical data, post-market surveillance findings, or significant changes in the SOTA.
In vitro Diagnostics (IVD)
Clinical performance studies must be conducted unless a valid justification is provided for relying on alternative sources of clinical performance data, as stated in IVDR Annex XIII. These studies aim to establish or confirm aspects of device performance that cannot be determined through analytical performance studies, literature review, or previous experience from routine diagnostic testing. For example, they assess whether the device can accurately detect or measure the specified analyte within the intended environment and target patient populations.
Full-Service CRO
Your advantage with CERES
Benefit from our interdisciplinary team of medical writers. As a full-service CRO, we focus
on medical devices, IVD and other medical technology solutions. We offer the compilation of modular, individual documents but as a qualified partner, we also take over your entire project. From consulting, to planning and writing to project management.
on medical devices, IVD and other medical technology solutions. We offer the compilation of modular, individual documents but as a qualified partner, we also take over your entire project. From consulting, to planning and writing to project management.
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Tailored Services
You choose with the help of our consulting services – is a tailored modular service ideal for you? Or do you prefer to book a package, intro or large?
It is your decision – just ask us. -
Transparent Costs
Whatever you decide you need – our modular services or the carefree package – you will receive a detailed offer with transparent and comprehensible costs. No hidden fees. -
Plan your ROI
Our expertise helps you to reach your aims sooner, more efficiently and more economically: to market introduction and a projectable and secure ROI. -
The Best Team for your Success
Our colleagues are experts in medicine, the sciences, biostatistics and engineering. This interdisciplinary team
takes you safely to your goal. -
Experience and Know-How
We combine decades-long experience with focused know-how – we are your partner at eye level! You can rely on
us – with us, you cannot go wrong.
We look forward to meeting you! -
A very strong
NetworkFor over 20 years, we have been working in this field – we are familiar with everyone involved! Rely on our strong network and benefit from a well-established CRO.
PEP Request
With care
and expertise –
for your IVD
You have developed an innovative medical device
and now want to conquer the market?
We support you in the most important core processes.
We make sure that all interfaces are defined and
considered. With us, you will always be up to date.
and now want to conquer the market?
We support you in the most important core processes.
We make sure that all interfaces are defined and
considered. With us, you will always be up to date.
Service Packages
From planning to approval –
everything is included
Instead of individual services, our customized packages offer an end-to-end solution – from planning to approval. from planning to approval. With structured project management, clear processes and a reliable dual-control principle, we ensure efficiency, quality and regulatory compliance in every phase of your clinical trial.
Large
With the most comprehensive package of CERES services,
you acquire the carefree package. Not only do we plan a clinical trial (both for market approvals and PMCF), we also carry out the trial, from biometrics and safety to communication with the authorities.
This is our core skill and our USP: thanks to our excellent network and our knowledgeable staff, multicenter, international clinical trials are what we do best. Our USP thanks to our
excellent network.
you acquire the carefree package. Not only do we plan a clinical trial (both for market approvals and PMCF), we also carry out the trial, from biometrics and safety to communication with the authorities.
This is our core skill and our USP: thanks to our excellent network and our knowledgeable staff, multicenter, international clinical trials are what we do best. Our USP thanks to our
excellent network.
Medium
The medium-sized package is aimed at manufacturers of
medical and/or IVD products who wish to make targeted use
of services to prepare for a clinical trial.
In contrast with the large package, however, we do not conduct studies within the medium-sized package, but provide you with comprehensive support in planning, strategy and the necessary preparations.
medical and/or IVD products who wish to make targeted use
of services to prepare for a clinical trial.
In contrast with the large package, however, we do not conduct studies within the medium-sized package, but provide you with comprehensive support in planning, strategy and the necessary preparations.
Small
The small package is our basic package for manufacturers
of medical and/or IVD products. With the literature analysis (SOTA), we pave the way for a successful clinical or performance evaluation, for which we prepare both the plan and the report.
On request, we can supplement the package with a comprehensive literature search that brings together relevant scientific data and findings.
of medical and/or IVD products. With the literature analysis (SOTA), we pave the way for a successful clinical or performance evaluation, for which we prepare both the plan and the report.
On request, we can supplement the package with a comprehensive literature search that brings together relevant scientific data and findings.
Intro
You are not quite sure what your next steps are, or whether
you need to collect clinical data? Whether you are a start-up,
an SME or a corporation, book our intro Package – we will provide clarity.
With our intro package, you receive our in-depth consulting, combined with a literature search, so you can make informed decisions based on a solid data foundation.
you need to collect clinical data? Whether you are a start-up,
an SME or a corporation, book our intro Package – we will provide clarity.
With our intro package, you receive our in-depth consulting, combined with a literature search, so you can make informed decisions based on a solid data foundation.