Clinical Evaluation FAQ
What is Clinical Evaluation?
What guidance is there? What documents do you need?
We have the answers…
Clinical evaluation plan
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.
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.
