CER, SSCP and PSUR
May 26, 2022
What’s the difference between CER, SSCP, and PSUR? Clin-r+ provides a break-down of the aspiration and content of each report, and explains why the reports are required under the EU MDR.
Category: Clinical Evaluation
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Clinical Evaluation Report
May 25, 2022
Composing the clinical evaluation report is one of the most difficult tasks when preparing a medical device submission under EU MDR. Clin-r+ has compiled a list of the top five most useful and reliable resources to consult when writing a CER for a medical device.
Summary of Safety and Clinical Performance
February 25, 2022
A Summary of Safety and Clinical Performance (SSCP) is an external document that includes information about a medical device, such as general information about the device, a summary of the clinical data for the device, and possible therapeutic alternatives. Clin-r+ provides information on what is required under EU MDR and how it is used.
State Of The Art Literature Reviews
February 25, 2022
Under MEDDEV 2.7/1 rev 4 regulations, literature reviews play an important role in several areas of the CER, including establishment of State of the Art (SOTA). The state of the art “describes what is currently and generally considered standard of care, or best practice, for the medical condition or treatment for which the device is used.”
Clinical Evaluation Assessment Report
February 25, 2022
A Clinical Evaluation Assessment Report is required for all manufacturers who want to sell medical devices in the European Union. CEAR demonstrates that your product accomplishes its intended purpose without endangering users or patients, and the manufacturer’s reputation or financial prospects.
Performing Effective Literature Searches
February 25, 2022
Performing effective literature searches for EU MDR and other regulations: Overall, the literature search must be exceedingly thorough, consistent, and cover a wide range of search parameters. CLIN-r+ looks at what’s effective.
Common Gaps in Clinical Evaluation Reports and Technical Documentation under the MDR
February 25, 2022
The first step toward planning a route to EU MDR compliance is to be aware of any compliance gaps. Clin-r+ highlights some common gaps in clinical evaluation reports and technical documentation when transitioning from the MDD to the MDR.
