Clinical Evaluations
Overview
It is not uncommon for Medical Device companies to gain CE marking without carrying out a Clinical Investigation in humans. However, a rigorous process is necessary to determine whether or not a clinical investigation is required. This process is generally known as a Clinical Evaluation, but often referred to as Literature Review/Search. The main purpose is to determine whether sufficient clinical evidence already exists to support CE Marking or whether a Clinical Investigation is necessary.
The amendment to the EU Medical Device Directive MDD 93/42/EEC places greater emphasis on clinical data and a Clinical Evaluation report.
Annex I, Essential Requirements now states: “Demonstration of conformity with the essential requirements must include Clinical Evaluation in Accordance with Annex X.” Companies must comply by 21st March 2010.
The Process
• Identification of the essential principles that require support from clinical data
• Full Risk Analysis performed according to International Standard ISO 14971
• Relevant considerations for design features including Safety and Performance
• Identification of relevant clinical data to the device and its intended use
• Collation of results to reach conclusions regarding clinical safety and performance
• Preparation of Clinical Evaluation Report.
How can Medvance assist you with your Clinical Evaluation?
Medvance specialises in reviewing medical device clinical data and we can ensure that your Clinical Evaluation report will meet all the European requirements.
Key Benefits
• We supply an extensive evaluation report plan which is supplied prior to the search
• Our Clinical Evaluation SOP is accredited to ISO9001:2008
• The process we follow is recommended by NB-MED, MEDDEV and GHTF
• Our procedure meets the requirements of the revisions to the directive
• Our Clinical Evaluation reports have been well received by Notified Bodies
Next Steps
Please contact us for more information or a proposal for preparing your Clinical Evaluation reports.
