Performance Evaluation Report (PER)
Bringing the untold story of your in-vitro diagnostic devices
What is a Performance Evaluation Report?
EU 2017/746 – also known as the In Vitro Diagnostic Medical Devices Regulation (IVDR) was adopted on May 25, 2017, and will replace the In Vitro Diagnostic Medical Devices Directive (IVDD). There is a transition period of 5 years making the Regulation fully applicable on May 26, 2022. Compared to the IVDD, there are massive changes confronting manufacturers with numerous challenges.
From the IVDR perspective, clinical evidence should support the intended purpose of a device as stated by the manufacturer and that is based on performance evaluation. This is guided by a performance evaluation plan (PEP) and clinical evidence file that should be combined as a performance evaluation report (PER)
Why is the Performance Evaluation Report Required?
PER Requirements
- Intended use or purpose of the device
- Indications for use, limitations, and contra-indications
- The General Safety and Performance Requirements (GSPR) supported by your performance evaluation
- List of recorded evidence for the device
- Performance specifications of the IVD
- A description of the current state of the art
- Benefit-risk ratio parameters
- List of analytical tests performed and what standards are used
- Intended target patient groups
- Analyte or marker to be used
- Foundation for underlying software decision making (if applicable)
01
Analytical
Correctly detect and measure a particular analyte
02
Clinical
Yield results for the intended use for target population
03
Scientific
Association of an analyte to a clinical condition or physiological state
- Performance Evaluation Plan (PEP)
- Performance Evaluation Report (PER)
- Scientific Validity Report (SVR)
- Analytical Performance Report (APR)
- Clinical Performance Report (CPR)
- Tech File Submission and Review
- IVDR Readiness Audits and Mock Audits
- Gap Assessments in the existing PER
Our Service Offerings
Scientific Validity
It is important that you start this early in the lifecycle of your IVD product. One way to do this is to use relevant information on the scientific validity of devices measuring the same analyte or marker. You should perform a detailed literature search but if inadequate evidence is available you will need to do proof of concept, pre-clinical studies, or clinical performance studies.
IVDR describes the performance characteristics you need to measure. These include sensitivity, specificity, repeatability, reproducibility, predictive value and more. You are required to maintain records of these performance characteristics for the life of the device. Plan your sampling carefully as the ability to create reproducible results is critical.
Analytical Performance
CLIENT TESTIMONIALS
We work continuously to receive customer feedback to provide them unmatched value. Here is what they say about us.
“Toby has had a smooth journey with Saraca Solutions. They have provided us with both a highly experienced Quality Manager and a very energetic Quality Engineer. Specifically, I would like to thank Saraca for closing our NCs in a timely manner while simultaneously performing a gap analysis on our entire QMS. Additionally, in preparation for an upcoming ISO audit, Saraca performed an internal audit on all of our major Quality subsystems. Lastly, Saraca Solutions faced our 2017 ISO audit, hand in hand with our staff, at Toby headquarters. I appreciate the end to end support provided by Saraca Solutions. This magnitude of interaction is unique among engineering services companies in the area of medical devices."
"Saraca was extremely helpful to our Product Team’s understanding of the requirements of ISO 13485 by presenting it to them in a simple and effective manner. They have also done a commendable job in helping us to align our deliverables in-line with the ISO 13485 requirements. With their help, our team was able to understand & implement the ISO 13485:2016 requirements effectively within a short duration. Their planning and execution methodology is superb. Overall, we are very happy with the outcome of our association with Saraca Solutions."
“Our team has partnered well with SARACA Solutions as we continue the development process for submitting one of ENT products for 510(k) review with US FDA. They constructed and maintain a Design History. They are also working on Risk Analysis as defined by our Quality Management System. The SARACA team has shown the depth of their experience working in the industry while seamlessly integrating well with us. In addition, their methods of collaboration ensure effectively developing the documentation and processes for our product management.”
Case Studies
We have provided a few projects which we have executed for our customers. Please reach out to us for more details.
