One question that arises, what is the level of evidence of patient registries within the hierarchies of evidence that are frequently used in developing guidelines or decision-making. As observational studies, registries would be placed in a subordinate position to RCTs.
Ensuring the quality of data must be one of top priorities of the sponsor. This task requires resources, expertise and coordination between the clinical investigator and the CRO for registry under mdr
Recruitment and retention
Recruitment and retention of patients are important in the design and excution of a registry. The main challenge described is the difficulties with patient enrollment, losses to follow-up, and certain sites contributing the majority of patients, can have profound negative consequences on the study validity because the patients that are enrolled are not randomized.
A small registry with few patients and data points may be easier to execute, but the data could lack depth and be less meaningful.
If the sample size of a key unit of analysis is not sufficient to detect a clinically important difference, the validity of the entire study is weakened.
Our team is led by former notified body and competant authority leadership. They have significantly contributed to MDCG guidance documents on clinical evaluation, sufficient clinical evidence, and PMCF. They were also involved in the development of the requirements of MEDDEV 2.7/1 rev 4, which are now reflected in the MDR.
At the end of a clinical trial, there is usually limited knowledge of the medium and long-term safety and performance of the device. The medium- and longer-term safety and performance of a device is estimated on the basis of premarket trial durations, that are generally inadequate to validate extrapolation hypothesis in real life, particularly implant longevity hypotheses.
ECLEVAR can help in collecting the clinical data required and provide long-term clinical strategy that support your business in EU, UK and Australia.
The main objective of any clinical evaluation is to demonstrate the safety and performance of a medical device. This is an essential process that is part of the conformity assessment procedure for obtaining the CE mark.
In the MDR, the scope and emphasis of the clinical evaluation is more important than in the MDD.
Eclevar, a CRO specialized in medical devices, hosts a 45-minute webinar dedicated to the changes in clinical evaluation under the MDR. In this webinar, we will review the requirements for clinical evaluation and the best practices to address these changes effectively.