Clinical Evaluation Report (CER)
The CER is an integral part of evaluating clinical safety and performance of medical device throughout its life cycle. It entails collection, analyses and appraisal of clinical data of the medical devices.
The triggers to update clinical evaluation involve complexity of the device, treating condition, or any significant risk information available through PMS activities.
Essential elements for clinical evaluation:
- Device description including its all variants/accessories and their physical and chemical characteristics.
- Classification of the device under EU-MDR.
- Route of clinical evaluation i.e. equivalency, literature review of similar device(s), existing technology or new device etc.
- Intended purpose of the device, invasiveness, duration of use and target population.
- Safety and performance claims.
- Market history.
- Identifying relevant information through clinical investigations, literature, vigilance search, and other PMS activities.
Our regulatory and clinical expertise is well-equipped with the necessary tools and skills to help you write a comprehensive CER in compliance with EU-MDR.
Post Market Clinical Follow-Up (PMCF)
As per EU-MDR 2017/745, the PMCF shall be understood as part of manufacturer’s proactive PMS activities. The purpose of the PMCF is to collect comprehensive clinical data on a medical device that bears CE marking in real-world scenario.
Through the PMCF, the manufacturer of the device is expected to ensure continued acceptability of identified risks, identify previously unknown side-effects, and monitor the identified side-effects and contraindications.
Steps to create the PMCF Plan:
- Gather all available clinical evidence on target device or (equivalent device, if applicable)
- Identify the clinical data gaps
- Develop a PMCF plan to collect the data on identified clinical gaps
The types of proactive PMCF activities considered to support clinical data for a medical device under MDR include:
- PMCF Clinical Study: Considered in the case of implantable devices and class III devices.
- Literature review: Conducted on target or equivalent devices and may include review of case reports for device’s misuse or off label use.
- Device Registry: Any possible evaluation of suitable national public registries with clinical data on the manufacturer’s own device and/or on similar devices.
- Real-world evidence: Planned Real-world evidence (RWE) analyses.
- Surveys: planned to collect information from users about the use of the medical device under review.
Want to know which approach would be appropriate for your device? We at LandmarkCRO provide you the complete solution to fulfil these PMCF requirements in compliance with EU-MDR.
Clinical Study Report (CSR)
Clinical study report (CSR) preparation for clinical trials requires monumental efforts as it involves dissemination of results to the regulatory authority.
A CSR is a pre-requisite in a regulatory point of view, as it reflects the true face of the clinical outcomes of device under study.
A well-written CSR contains the neatly organized representation of clinical analyses and statistical description inserting tables and figures, which can ease review process for regulatory authority.
Our medical writers have experience in writing a high quality CSR in compliance with regulatory guidelines for medical devices covering various medical domains.
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