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Post-Market Clinical Follow-up (PMCF) is necessary for maintaining medical device regulatory compliance, and with the EU MDR, clinicians increasingly need to collect PMCF data for lower-class medical devices (i.e., class 1 and 2a devices) and WETs (Well Established Technologies).
Many medical devices used in the EU fall under the lower-class or WET categories, and it is especially important for the industry that obstacles to complete PMCF for these devices are minimal. While EU’s Clinical Device Regulation does not explicitly define WETs, the MDCG 2020-6 lists their prerequisites, with some common examples being sutures, wires, and braces.
Clinicians often overlook the importance of PMCF for lower-class devices and WETs due to the established usage of these devices within the industry, often with months and years of track records. However, this is a misconception, as a well-known safety profile or performance characteristics do not account for the changing industry and emerging risks.
Essentially, a PMCF plan provides clinicians with reliable methods and guidelines for collecting data for reporting purposes and product improvement. Clinicians should note that PMCF is not a target outcome or one-time event but a continuous process involving a systematic approach. Find out why PMS (Post-Market Surveillance) is important.
This blog can help manufacturers and sponsors simplify their PMCF data collection for lower-class devices and WETs. In addition to the blog, we hosted a webinar on the topic.
There are three significant benefits tied to optimized PMCF processes, which focus on the safety and performance of devices. The collected data provides an actionable guideline on what manufacturers need to achieve for the end-user. Read our practical guide on PMCF here.
PMCF enables manufacturers and clinical teams to work together to discover the earliest signs of end-user dissatisfaction or technical errors resulting from device use. Therefore, clinicians can provide quicker feedback to manufacturers to facilitate product improvements.
Through PMCF, manufacturers gather and present quantifiable and analyzed data to prove the performance and safety of their devices.
The research and data from PMCF activities provide manufacturers with detailed real-time information to improve existing devices, hence enabling product performance optimization.
PMCF activities fall under three broad categories — surveys, clinical experience, and interventional clinical investigations. Each method comes with varying costs and timelines.
Regarding lower-class medical devices and WETs, manufacturers should prioritize surveys and clinical experience, as interventional clinical investigations are often not necessary to provide the data required to successfully conduct PMCF. Most of the high-quality data originates from clinical experience of end-users, highlighting the most pressing considerations according to firsthand experience.
While some manufacturers may turn to clinical investigations, these are costly and time-consuming processes. The academic process often proves cumbersome and ineffective compared to clinical experience, which relies on observational studies within real-life settings.
Additionally, clinicians may provide clinical experience data through access to medical records on device’s performance and safety metrics without requiring lengthy regulatory clearance from authorities. In many cases, the published findings of clinical experience may prove adequate as a reliable data source, avoiding the need for costly investigations.
Both organizational and analytical factors affect the efficiency of PMCF activities. Clinical teams should take a multifunctional approach involving sales and marketing to implement a clear strategy across the organization.
Clinics may lack the organizational structure and data-focused mentality to conduct routine PMCF activities, as well as the readiness to collect valuable data with suitable tools, methods, and processes.
Some clinicians may not possess the infrastructure, documentation, and statistics necessary for facilitating PMCF activities. As a result, teams may lack the competency to achieve PMCF activities reliably and effectively for manufacturers.
For example, clinics should work with a scalable data software solution as a base. Non-validated methods such as paper and Excel spreadsheets do not provide a foolproof centralized database for maintaining cross-functional communications and collaborations, and do not comply with the requirements of ISO 14155:2020.
A scalable software provides teams with structured datasets required for drawing meaningful insights and observations. By linking the scalable software with one database, teams can expedite and enhance cross-functional communication, driving several advantages (e.g., increasing marketing performance and lowering subject dropout rates).
Proper documentation should include a viable clinical evaluation report (CER), updated device statuses, and the latest PMCF templates that facilitate the data collection process. Combining the components creates a coherent narrative that establishes a quality management system (QMS).
Teams should always check through their QMS before initiating PMCF activities. Erroneous data, such as outdated contact information, will waste valuable time and resources and result in misalignments between distributors and end-users.
Evnia provides specialized support for PMCF planning, implementation, and management, and in collaboration with Greenlight Guru Clinical the team offers customized approaches according to an organization’s unique profile and requirements, as highlighted in the following use cases.
Greenlight Guru's electronic data capture and management solution enables ad-hoc case series reporting where clinical experts can provide data, unlike other surveys that run on an anonymous or non-identifiable basis. Furthermore, the reports appear as simple questionnaires that collect data from multiple devices in the same family, with complete flexibility in endpoint design and structure.
Greenlight Guru Clinical completed the process by implementing a data collection solution that cross-checked claims from multiple areas (e.g., SRS, IFU, and marketing). The finalized solution enabled the client to focus on specific quantitative data that drives the performance and safety of their devices.
Unlike the first case study client, this organization needed to acquire PMCF data directly from end-users. The clinical team started by identifying distributors from which they could gain access to end-users, contract, and present the value.
As with all PMCF processes, there was a need to ensure cross-functional involvement and cross-check claims from multiple areas. The team needed to understand the overall workflow for the case study to discover the most suitable time to ask end-users the appropriate questions.
Greenlight Guru Clinical introduced an ePRO (electronic Patient Reported Outcomes) solution, which was set up as a questionnaire based. Through a well-designed landing page, the process was facilitated through public enrollment of participants who were recruiting locally but collecting data globally.
The data was collected in record time over the course of 3 months, for almost 200 cases in over 10 countries from North America to Europe and South-East Asia.
In short, manufacturers can optimize the PMCF process with a systematic approach that involves methodical changes in organizational mindsets and data collection/analytics. Teams should establish a CER at an MDR level before starting a PMCF. Secondly, clinical teams should always align PMCF data with claims to achieve quantifiable and relevant information.
All valuable insights and PMCF data should be stored in a centralized database to facilitate seamless communication among cross-functional teams.
Additionally, it is integral to run through QMS across the organization before going ahead with the PMCF, which includes discussing fundamental touchpoints such as describing a PMCF plan. Organizations should define processes and qualify the files needed to document a PMCF strategy.
Perhaps most importantly, clinicians need to understand that data collection goes beyond PMCF activities such as surveys and clinical experience. Teams should constantly seek research tools and methods that present new opportunities to improve lower-class devices and WETs in an industry that continues to face rapid change.
Greenlight Guru Clinical is the only electronic data capture (EDC) software made to accommodate the regulatory framework and clinical workflow for MedTech companies. When it comes to PMCF compliance under EU MDR, our EDC software streamlines the data collection from surveys, case series, etc. It is also a pre-validated solution and works in compliance with ISO 14155:2020 and FDA CFR 21 part 11 requirements.
Reach out to us and let us show you how Greenlight Guru Clinical can significantly simplify your PMCF data collection and compliance.
Jón Ingi Bergsteinsson, M.Sc. in Biomedical Engineering, is the co-founder of Greenlight Guru Clinical (formerly SMART-TRIAL). He was also the technical founder of Greenlight Guru Clinical where he paved the way for the platform’s quality standards, data security, and compliance.