We prepared a final clinical evaluation report with examples about a medical device’s general safety and performance requirements based on the clinical data during the pre-market and post-market stages.
Identification, collection, appraisal, and analysis of the medical device’s pre-market and post market clinical data in order to demonstrate MDR GSPR compliance
- A clinical evaluation report template should be compiled to document the clinical evaluation with a specified time schedule.
- It should provide enough detail to understand the search criteria adopted, the available data, all assumptions made, and all conclusions reached.
- The contents of the CER are relevant to the medical devices, which should vary according to the nature and history of the device under evaluation.
A description of the device under the clinical evaluation plan should be provided. The scope of the clinical evaluation should include the identification of devices covered by this report, products, models, sizes, software versions, accessories, whether they are on the market, since when, in what regions, history of the device, and, in case of an update in the plan, including the date of past modifications with reasons and descriptions, sales volumes, and changes since the last report. The identification of the sections of the CER that are concerned with the new information and have been modified should be detailed.
We Provide Clinical Evaluation Report including:
Our writing team has developed easy to use and edit clinical evaluation report templates, procedures and SOP's.
FAQ's
What is Device Classification?
Classification of the device as per Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices should be mentioned.
What is know as Intended purpose
Exact description of the intended purpose as described in the device's IFU with exact medical indications (if applicable); claims made in available promotional materials. This section summarizes:
• Disease and its severity or aspects
• Medical indications
• Target population and intended user
• Body parts affected
• Duration of use
• Type of use (single or reusable)
What are to be considered under Device Description
• Device name
• GMDN code
• Brand name, models and variants, size and UDI-ID number
• Software versions and product code
• Physical and chemical description, including materials.
• Constructional materials
What is know by Data generated and held by manufacturer?
This section shall include details of clinical investigations, if any, PMS, PMCF, complaints, details of field safety corrective action, other user reports, relevant preclinical study data (bench test reports, verification and validation data).
What is the relevance of Bench Testing?
The results obtained from any external laboratory or in house and its evaluation in significance with clinical evaluation should be provided.
What are to be considered for next year evaluation
• The significant risks of device if high-risk or medium, high-risk target populations, severity of disease/ treatment challenges, duration of risk.
• Whether the device is well established or the innovation is there, the current level of confidence in the evaluation of clinical performance and clinical safety of the device from the data available from clinical investigations, PMCF studies, registries or other systematic studies, reports of risk or adverse event rates under the vigilance system.
• The clinical evaluation is actively updated with :
When new information is received from PMS that has the potential to change the current evaluation; if no such information is received, then at least annually if the device carries significant risks or is not yet well established; or every 2 to 5 years.
If the device is not expected to carry significant risks and is well established, a justification should be provided.