European Directive 2007/47/EC, which amends the EU Medical Devices Directive MDD 93/42/EEC (and Active Implantable Medical Devices Directive AIMDD 90/385/EEC), places greater emphasis on clinical data and a Clinical Evaluation Report. Recital 8, which is in the preamble of Directive 2007/47/EC, makes the statement "clinical data, even for Class I devices, will generally be required." Also, Annex I, Essential Requirements now states: "Demonstration of conformity with the Essential Requirements must include a clinical evaluation in accordance with Annex X." Companies must be in compliance by 21 March 2010.
What is clinical data?
Clinical Data is an important component of the CE Marking process. It is defined and included in Article 1.2 (k): "The safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:
- clinical investigation(s) of the device concerned; or
- clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
- published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated."
How can we assist with the medical device Clinical Evaluation Report or Clinical Literature Review?
Clinical evaluation entails the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device. Emergo specializes in reviewing medical device clinical data, and we can ensure that your Clinical Evaluation Report meets all European requirements. We can assist you in developing a procedure to perform these Clinical Evaluation Reports and Clinical Literature Reviews, or we can prepare them for you based on your procedures. If necessary, we can develop a protocol to methodologically search and evaluate journal articles and provide a synopsis.