Clinical evaluations
Clinical evaluations for medical devices and performance evaluations
Clinical evaluation or performance evaluation is an essential part of the conformity assessment of medical devices and IVD medical devices and mandatory according to the applicable EU regulations: the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). Our experts can help you to meet these clinical evaluation and performance requirements.
In the recent years, the bar has been rising for clinical data requirements both in the EU and outside the EU, and the question of whether there is enough clinical data available from equivalent products or if clinical investigations are needed is of critical importance. No matter if you plan to tackle the requirements with review of published literature or clinical investigations of your own, we can provide the expertise and resources in:
Creating product-specific strategies to meet clinical data requirements
Writing clinical evaluation and performance evaluation plans and reports
Planning, performing and reporting systematic literature reviews
Writing post-market clinical follow-up (PMCF) and post-market performance follow-up (PMPF) plans and reports and assisting in PMCF/PMPF activities
Effetre manages clinical investigations and clinical performance studies from site and investigator qualifications to report preparation.
Since the Medical Device Regulation and In vitro Diagnostic Medical Devices Regulation have been taken into use, the requirements have become much more demanding than before, which means that more and more companies are obliged to perform clinical investigations. As a result of this, experience in managing medical device investigations has increased significantly in the recent years.
In the performance evaluation for an IVD medical device key aim is to demonstrate the performance (analytical performance and clinical performance) of the envisioned IVD medical device for the intended use as stated by the manufacturer.
Our in-depth knowledge of medical devices ensures that your investigations and studies meet the recent requirements for clinical investigations and performance studies set forth in the standards.
MDD Clinical Evaluation Report – IVD Performance Evaluation Study Medical device clinical evaluation refers to the process where the manufacture validates whether the product meets the operational requirements or falls within the applicable scope through clinical literature, clinical data, and clinical trial. We can provide Clinical Evaluation Report (CER).