Your device already has CE approval and you need a Post-Market Study?
Goals of Post-Market studies are
- market surveillance by Post-Market Clinical Follow-up (PMCF) studies
- market release and introduction of your new device or technology
- explore or improve device acceptance
- evaluate cost-benefit ratio for reimbursement
- collect long term experiences on real world patients
PMCF studies are part of the Post-Market Surveillance (PMS) of medical devices. A PMCF study can determine whether the safety and performance of your medical device are still valid, even years after market launch. Through PMCF, potential changes in device usage, and faults and weak traits of a device can be detected earlier and modified, leading to better, lower-risk products.
CERES supports customers to plan and conduct Post-Market studies for medical devices efficently.
According to MDD and AIMD the manufacturer has to keep the clinical evaluation of the devices up-to-date. A Post-Market Clinical Follow-up study can fulfil this responsibility. These activities should be intensified no later than 2020 as a result of the applicable MDR. Clinical data should be collected according to the relevant guideline for PMCF, MEDDEV 2.12/2 rev2. PMCF studies also serve to provide market surveillance and monitor market acceptance.
If your device already has CE approval and you need to perform a clinical study within the intended use of the product, an approval from the competent authority (e.g. BfArM in Germany) may not be necessary.
CERES offers the full chain of services for clinical studies.
We can manage your PMCF study and help you with planning and design. We offer consultation for eligibility and submission procedures. We can select your study sites, monitor your study, analyze the clinical data, and write the study reports. Thus, we can run your whole study or provide just the help you need to succeed.
CERES provides the following services:
- Composition of study-hypotheses, aims and endpoints
- Evaluation of the adequate study-type with respect to
size of the population, test-significance and duration of observation
- Selection of population and planning of recruitment
- Specification of suitable statistical reporting and analyses
- Creation of the clinical investigation plan (CIP)
- Selection of study centers and clinical investigators
- Study preparation and justification
- Data management
- Communication with ethics committees and authorities
- Preparation and registration of documentation components and case report forms (CRF)
- Data capturing and administration
- Checking on plausibility, integrity and validity of data
- Independent monitoring
- Preparation of the data
- Description of the sample
- Tests on hypotheses and identification of parameters
- Descriptive and explorative data analysis
- Interpretation of the results
- Evaluation with regard to performance and effectiveness
- Monitoring reports
- Interim reports
- Final reports
CERES has extensive clinical experience with numerous medical devices, including drug-device combination trials.