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.
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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?
To answer the first question, during the initial CE marking, if a manufacturer’s device is on the non-EU market for a long time, they can actively and systematically gather, record and analyze relevant data of the non-EU marketed device as it will contribute to the device quality, performance, and safety. This is applicable during the cases there are insufficient data to prove certain uncertainties as well. There are scenarios where NBs have accepted it. However, it is ideal to obtain post-market data from the EU once the CE mark has been attained, especially, while performing the PMCF study. If data is not from the non-EU market, substantial rationale needs to be provided on how the safety and performance could be applicable for the EU population.
Secondly, it is understood that the endpoints identified such as a new risk or new side-effect from the literature review or any other uncertainties identified during a device’s normal use or during Clinical Evaluation, Risk management, previous post-market activities(PMCF and PSUR), determine the criteria for identifying the questions to be included in PMS activities.
Yes, Data from PMS/PMCF activities from non-EU countries taken into consideration for CE marking during non-availability of sufficient clinical data as it play important role in proving device safety and performance.
Proper justification should be given with an analysis of
• if the results are transferable to the EU population
• any gaps to address between GCPs and relevant harmonized standards
However EU data will always be given priority.
Any new risk or uncertainties identified during its post marketing use, clinical evaluation or risk management are considered as basis for identify the questions to be addressed in PMS.
For product already in market, identified latest PMS/PMCF data considered to update the CER.
PMS is generally carried out after the device is released in the market. It is done in order to answer specific questions related to safety and performance of device which could not be answered by premarket investigation of the device.
If the device is already available in market in non-EU countries, the data obtained from PMS activities done in Non-EU countries can be considered during the CE marking of the device, if that data is transferable to EU population and manufacturer is able to bridge the gaps by giving proper justification.
The criteria used for identifying questions to be included in PMS depends on:
Whether there is change in the conditions of use of device (from hospital to home or new environment) or new patient population, change in device technology, uncertainty about the long-term safety and performance of the device, change in the severity or nature of the adverse events reported, significance of risk to public health. In all these cases PMS is necessary to identify the problem and determine the corrective action to be taken. Priority will be given to the question based on the magnitude of risk identified.
Yes, the data obtained through post market activities from outside the EU countries be considered to be relevant during the CE marking because the data is related to the device safety and performance. If the data is transferable to EU population and manufacturer is able to utilize the gaps by giving the suitable justification. Generally PMS/PMCF conducted after the device is released in the market..
The criteria for determining the questions to be included in post market activities are defined by the changes identified, including a new risks of the device and new side effects and uncertainty identified during the device use, risk management and clinical evaluation.