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Role of the Notified Body in Post Market Clnical Follow Up Review

Post Market Clinical Follow Up (PMCF) is a part of Post Market Surveillance (PMS)

Notified Bodies are insisting for proper controlled documentation for Post Market Clinical Follow Up (PMCF) so manufacturers are facing compulsion to provide detailed technical documentation.

This evidence should support any and all claims and indications regarding the device and residual risks. Well organized documents with correct justification and conclusions will boost the confidence of Notified Body about your Medical Device.

Secondly, the draft EU Medical Devices Regulations published in September 2012 incorporates MEDDEV guidance on both vigilance and Post Market Clinical Follow Up are indicative of the laws that currently govern EU requirements, and there are continued legislative efforts to make Post Market Clinical Follow Up and Post Market Surveillance an even more authoritative presence within the law.

This  approach aims at providing more transparency for the medical community and patients, working toward a better guarantee of long-term safety and performance
In addition to the broad commitment to improve delivery on the promise of long term safety and efficacy, industry trends have contributed to the need for a greater emphasis on Post Market Clinical Follow Up.

We consultants, will guide you through the enter process of Post Market Surveillance & Post Market Clinical Follow Up process by developing procedure, relevant templets, review of documents and finally consolidation of data in a manner accepted by most of the notified Bodies.

INDIA – Bangalore
+ 91 994 591 2081
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+1 630 696 1293
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+49 2161 990 8831
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