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A Watchful Eye on Device Performance can Decrease Postmarket Surveillance Burdens

The Lifecycle Approach is a Worldwide Initiative

Lifecycle postmarket surveillance is an approach to market surveillance that involves use of data and information from all stages of the lifecycle of a medical device to direct and support the conduct of surveillance activities and investigations. The outcome and findings from these postmarket investigations are used to update, develop and reinforce new premarket requirements.

The FDA Approach: CDRH 2016-2017 Strategic Priorities Information generated through the Medical Device Postmarket Surveillance System should meet priority public health and healthcare needs related to medical device safety and effectiveness, including:

  • Providing better information to support patient, clinician, health system and payor decisions about medical devices  
  • Informing CDRH’s regulatory decision-making to ensure safety and accelerate product innovation (facilitate premarket approval/clearance and expansion of indications for existing devices) 
  • Mitigating potential harms by supporting rapid response to device safety problems
  • Gathering information about existing products to inform the development of new and innovative devices, and
  • Improving health outcomes through better decision-making based on information from real world experiences with medical devices

FDA may identify device issues that are appropriate for postmarket surveillance at any point during the life cycle of a device. Such issues may be identified through a variety of sources, including analysis of adverse event reports, a recall or corrective action, post-approval data, review of premarket data, reports from other governmental authorities or review of scientific literature.

Examples of situations that may raise postmarket questions and push FDA to order postmarket surveillance include:

  • To understand the nature, severity or frequency of suspected problems reported in adverse event reports or in the published literature
  • To obtain more information on device performance associated with real-world clinical practice
  • To address long term or infrequent safety and effectiveness issues for implantable and other devices, for which premarket testing provided more limited information
  • To understand rates of malfunction or failure of a device intended for long-term use or incidents of latent issues resulting from device use
  • To define the association between problems and devices when unexpected or unexplained serious adverse events occur after a device is marketed, if there is a change in the nature of serious adverse events (e.g., risk-based severity), or if there is an increase in the frequency of serious adverse events

Specifically, actions to be enabled by FDA include:

  • Establish a Unique Device Identification System and Promote Its Incorporation into Electronic Health Information
  • Promote the Development of National and International Device Registries for Selected Products
  • Modernize Adverse Event Reporting and Analysis
  • Develop and Use New Methods for Evidence Generation, Synthesis and Appraisal

The EU Approach: Postmarket surveillance based upon risk

Postmarket surveillance is an integral part of the European Medical Device Regulation (MDR), neatly aligned with the requirement to evaluate your medical device through the lifecycle of the product. The Medical Device Directive (MDD 93/42/EEC) referring to the need for postmarket surveillance is very obvious for all classes of medical devices. It indicates that for any device, proportionate to the risk class and appropriate for the type of device your company shall plan, establish, document, implement, maintain and update a postmarket surveillance system which shall be an integral part of the manufacturer’s quality management system. For each medical device, whether it is a high risk active implant or a low risk manual instrument, postmarketing data must be collected. However, the scope of this approach can vary and shall be proportionate to the risk class of the device.

Previously, a reactive approach for lower risk devices, e.g. in the form of vigilance registries, would be acceptable, as long as strong clinical evidence for safety and performance was expected based on premarket data. Currently, it is more likely that your Notified Body requires you to proactively collect data on the clinical safety and clinical performance of your device, regardless of its classification. After all, the user’s threshold for vigilance reporting may limit you to obtain sound evidence of “real-life” safety and performance data. The exact requirements for proactive data collection, e.g. on user experience, are not set and should be discussed between your company and your Notified Body. Yes, the scope and detail of this surveillance effort is negotiable to a certain degree. The aim of surveillance is to ensure that your company fulfils the obligations imposed by the approved and compliant quality management system.

Goals for the Postmarket Surveillance Process in Europe:

  • Public health is protected effectively
  • Medical devices placed on the market continuously conform to the requirements for safety and performance
  • Problems or changes in safety and performance of a medical device are detected and acted on in an effective and timely manner
  • Medical device market surveillance activities are effective to cover national responsibilities and provide valuable input into European system
  • Data gathered from market surveillance is used to drive better standards of safety and performance - inform other phases in the lifecycle

  • Challenges Concerning Postmarket Surveillance Process in Europe:

  • Different interpretations and approaches to the activities that constitute medical device market surveillance
  • Decentralized system for conformity assessment/certification and market surveillance – chain is only as strong as the weakest link
  • Lack of transparency and information on products available
  • Array and complexity of medical device technologies and ensuring effective regulation
  • Iterative nature of medical device product development
  • Learning curve associated with technology advances

    Next: Take these steps to start collecting the right data


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