Clinical Evaluation FAQ
What is Clinical Evaluation?
What guidance is there? What documents do you need?
We have the answers…
Clinical Evaluation Report
Clinical Evaluation for Medical Devices
MEDDEV 2.7/1 Rev 4 is a Clinical Evaluation guide for manufacturers and notified bodies and the MDR provides further information on the clinical data requirements. CLIN-r+ explains the key stages of clinical evaluation and what documentation you need.
CER, SSCP and PSUR
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.
Clinical Evaluation Report
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.
State Of The Art Literature Reviews
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.”
