Recent amendments made to the Medical Device Directive (MDD 93/42/EEC) state that every medical device affixing CE Logo, regardless of its classification, must have a clinical evaluation report in its Technical File / Design Dossier.
The Directive specific focus on implantable or class III medical devices gives the false impression that clinical investigation does not apply to other Medical devices. This has lead to the current situation where clinical trials are rarely done in the pre-market steps of medical devices development.
Clinical investigation is rarely conducted because of the investment in time, human resources and costs. In addition, clinical investigation is sometimes perceived as risky or harmful. As With the implementation of Directive 2007/47/EC, clinical evaluation has become a central element of regulatory compliance under the Medical Device Directive and Active Implantable Medical Device Directive.
Manufacturers of medical device face the greatest impact, as they must present complete and sufficient clinical evaluation files to ensure timely assessment and favorable review of their products.Benefits of Conducting Clinical Evaluation
Appoint I 3 CONSULTING for better navigation and ensure timely assessment and favorable review
Our systematic approach includes support in protocol generation, develop fast method to complete clinical evaluation documentation and complete proper conclusion. Our services are online and very economical. We entertain enquiries across the globe.
Our fees normally range between 1200 USD to 2500 USD depending upon your productGet a Customized Proposal