Post market activities are critical to generate clinical data regarding the medical device that may identify rare events and incidents which were not previously identified. It also brings forth the advantages specific to your medical devices, which improve the competitive edge of your device and keep Clinical Evaluation Report updated. Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) are the post market activities used to obtain data regarding the medical device.
PMS is used by manufacturers to actively and systematically gather, record and analyze data, which can be used to ensure continued quality, safety and performance throughout the lifetime of the medical device. The PMS data is obtained from reactive sources and proactive sources. Reactive data is obtained when some complaint or problem occurs and proactive data is obtained through steps taken by manufacturer before any problem arises.
Among the post market activities clinical data is generated only through PMCF, which is normally carried out following the CE marking of the medical device and are intended to answer specific questions relating to clinical safety, performance, residual risks etc. when the medical device is used as intended by the manufacturer. The PMCF data is obtained through the use of the medical device on actual patients and will give a clear measure of the clinical safety, performance, residual risks etc. of the device, which can be used to demonstrate the conformity to general safety and performance requirements.
But in some cases, if sufficient data regarding uncertainties, unanswered questions, residual risks or rare complications are not obtained through literature search and from other tests conducted by manufacturer, PMCF is conducted before CE marking at clinics or hospitals outside the European Union (EU), where the medical device is already available in market.
Will the data obtained through post market activities outside the EU be considered to be relevant during the CE marking? What are the criteria used to identify the questions to be included in post market activities?