Effective post-market surveillance

1 Effective post-market surveillanceUnderstanding and conducting vigilance and post-market clinical follow-upIbim Tariah, technical Expert, BSI AmericasRebecca Pine, Medical Devices Consultant2 Effective post-market surveillance BSI BSI/UK/440/ST/0614/en/HLIntroductionIn order to comply with the European Union (EU) Medical Device Directives 90/385/EEC Active Implantable Medical Directives (AIMD), 93/42/EEC Medical Device Directive (MDD) and 98/79/EC In Vitro Diagnostics Device Directive (IVDD) (referred to as The directives hereafter), manufacturers must conduct post-market surveillance (PMS). As outlined in the quality assurance area of the annexes of these directives, PMS requires: 1.

2 That the manufacturer institute and maintain an up-to-date systematic procedure to review experience gained from devices in the post-production phase, which include provisions referred to in Annex X (93/42/EEC), or Annex VII (90/385/EEC) and;2. the implementation of appropriate means to apply any necessary corrective ,2,3 The directives requirements are complemented by harmonized standards EN ISO 13485, Medical Devices4 and EN ISO 14971:2012, Medical devices: Application of risk management to medical EN ISO 13485 gives an outline of a quality management system (QMS) structure which compels the need for a feedback system specifically to provide early warning of quality problems and for input into corrective and preventive action processes.

3 In addition to the pre-market assessment of risks associated with a new device, EN ISO 14971:2012 specifies requirements for production and post-production information to be considered as part of the overall risk assessment process throughout the life of the directives, in conjunction with the harmonized standards, form a framework for manufacturers to develop a comprehensive feedback system intended to ensure the continued safe-use of a device for the manufacturer s intended are the requirements of post-market surveillance ?PMS is a collection of processes and activities used to monitor the performance of a medical device. These activities are designed to generate information regarding use of the device to expediently identify device design and/or usage problems and accurately characterize the real-world device behaviour and clinical outcomes.

4 The need for PMS arises immediately upon commercialization of the adequate medical input into the risk management process during product development will help manufacturers characterize possible product safety issues. The risk profile of the device evolves from these efforts and can be used to effectively develop the PMS strategy for the device. It is important to note that the requirements for PMS should be directly proportional to the risk associated with the device based on its intended developing a robust PMS process, manufacturers should consider whether or not the product or technology is new to the manufacturer and/or the marketplace. Where a manufacturer has a long history of development and marketing of similar device types, they are likely to have a clear understanding of the patient population and the reasonably foreseeable risk associated with the device.

5 Available data regarding state-of-the-art market experience for similar products and technology may be adequate for low-risk devices with a long history of clinical use. For those manufacturers pursuing the literature route to support clinical evaluation requirements,2,6 these data types often give the manufacturer knowledge of the patient population, co-morbidities and the effect of different patient demographics for the use of the device. Literature of high quality ( randomized control trials, meta-analysis) will give manufacturers quantified clinical data regarding the safety profile of these device the case of new technology, manufacturers often have a limited understanding of the patient population and the complexities of the disease state, which may affect the performance of the device.

6 This limited knowledge may result in under or over representation of risks in the pre-market assessment of the device design and its interaction with the patient/user. Manufacturers introducing technology new to the organization should respond accordingly with an increased monitoring program to ensure early detection of problems not foreseen in development. Also of concern is the extent of available scientific knowledge for new devices. In the case of novel or new treatments, knowledge of long-term effects may be limited. post-market clinical follow-up (PMCF) may be warranted to ensure adequate characterization of the real-world clinical use of the BSI BSI/UK/440/ST/0614/en/HLPMS could be reactive responding after an event; of which there are many types ranging from complaints to those involving serious injury or in an extreme case where a serious injury or death has occurred known as Vigilance.

7 These activities can be considered passive as they are largely data collection activities. On the other hand, PMS could be proactive endeavours meant to anticipate and curtail events before they occur; there are many types such as user surveys, manufacturer-sponsored clinical registry studies, PMCF studies. In proactive PMS activities, information is actively sought to gain insight and data into the real-world performance of the shown in Table 1, the flow of information into risk management comes from a wide variety of activities and individuals including patients, physicians, healthcare facilities, regulatory authorities, professional societies, researchers and internal personnel.

8 Analysis and review of PMS data is part of the risk management process and should be performed by manufacturers on a routine basis. Ideally, these reviews are performed during formal management 1 Relationship between QMS, reactive PMS and proactive PMSQMSPMS NBMed MEDDEV follow-upMEDDEV PMSP roactive PMSP roactiveReactive Customer surveys Post CE mark clinical trials, including PMCF Manufacturer sponsored device tracking/implant registries Expert user groups (focus groups) Customer complaints Unsolicited user feedback (other than complaints) Maintenance/service reports In-house testing (routine) Failure analysis Social media Literature reviews Regional or national device registries (non-manufacturer sponsored trials)

9 Table 1 Examples of PMS data and their respective action types4 Effective post-market surveillance BSI BSI/UK/440/ST/0614/en/HLPMS requires that manufacturers detail how often key documentation, that is used to demonstrate conformity to the essential requirements (ERs) will be updated in response to information gained during the ,2,3 It is important to note that a combination of proactive and reactive PMS activities form the basis of the device s PMS plan. A PMS plan must be provided as part of the assessment for CE mark certification and should be based on available clinical data and an assessment of residual of the particular device or implementation of a PMCF trial, manufacturers still need to perform the reactive post-marketing activities that include vigilance, complaint handling, and reviews of clinical literature and databases.

10 PMS requirements outlined in the directives require a manufacturer to notify the competent authorities of serious device-related events, known as incidents immediately upon learning of ,2,3 This implies that during the post-production phase, manufacturers must have an established system for vigilance that is appropriate for gaining and reviewing experience in the post-production phase from the range of devices formulating the device PMS plan, it is pertinent to remember that ISO 13485 applies to all medical devices on the market and in the context of this standard, early warning means proactive PMS. A PMCF study is expected as part of a post-market surveillance plan. There should be an adequate rationale if a PMCF study is deemed products are the output of various processes within a quality management system, it is beneficial to discuss vigilance, post-market clinical planning and data as a critical part of the design dossier and/or technical documentation of a device.