Clinical evaluation: from initial planning to post-market clinical follow-up
According to Regulation 2017 / 745 (MDR), clinical evaluation is an essential part of the conformity assessment procedure for manufacturers of medical devices of all risk classes for successful market access. The clinical evaluation serves as systematic proof that the medical device fulfils basic safety and performance requirements and that undesirable side effects are taken into account and excluded. Thus, it serves as evidence of the justifiability of the benefit-risk ratio.
Furthermore, the continuous and regular updating of the clinical evaluation after the medical device has been placed on the market is part of the Post Market Clinical Follow-up (PMCF).
How we support you in all phases of a clinical evaluation
Planning and strategy
First, the process and the requirements for the product are planned and a strategy for obtaining clinical data is developed. This data can be obtained via studies from scientific literature research or/and from clinical trials.
Clinical expertise
In this context, we work closely with experts from university hospitals and physicians in order to be able to draw on the necessary medical expertise for the clinical evaluation.
CEP and CER
This process is part of the technical documentation, so that all steps of the clinical evaluation must be recorded in a report. The Clinical Evaluation Scope & Plan (CEP) and the Clinical Evaluation Report (CER) are obligatory documents that are constantly updated over the product’s lifetime using PMCF data.
PMCF
In the area of Post-Market Clinical Follow-up (PMCF), we focus on the precise fulfillment of all regulatory requirements. We support you in systematically collecting data from clinical studies and scientific research.
We not only ensure that the Clinical Evaluation Scope & Plan (CEP) and Clinical Evaluation Report (CER) are updated promptly, but also that all PMCF data is meticulously documented and analyzed. This is how we help you to ensure the long-term conformity of your medical device and optimize its performance and safety.