How to Collect PMCF Data for Lower-Class Medical Devices and WETs

February 9, 2022
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PMCF data collection for lower class devices and WETs

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. You can watch it right here:

Understanding Benefits of Optimizing PMCF

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 SMART-TRIAL’s Practical PMCF Guide here.

1. Proactively discover emerging risks

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.

2. Validate medical device efficacy

Through PMCF, manufacturers gather and present quantifiable and analyzed data to prove the performance and safety of their devices.

3. Update and improve clinical performance

The research and data from PMCF activities provide manufacturers with detailed real-time information to improve existing devices, hence enabling product performance optimization.

PMCF Methods/Activities

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.

You can also read our in-depth guide to selecting the right PMCF Activity.

Identifying the Challenges in PMCF Activities

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.

Management/organizational considerations

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.

Data collection/analytical concerns

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 emails 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 dropout rates). See how SMART-TRIAL’s scalable data gathering platform can help your data collection.

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.

PMCF Use Cases

Evnia provides specialized support for PMCF planning, implementation, and management, and in collaboration with SMART-TRIAL the team offers customized approaches according to an organization’s unique profile and requirements, as highlighted in the following use cases.

Use Case #1 – Experienced WET Device User

Client Profile:

  • WET device user with over 20 years of clinical usage
  • No PMCF experience or proactive data collection initiatives
  • Low-quality CERs that fail to drive effective decisions

SMART-TRIAL’s data gathering 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.

SMART-TRIAL 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.

Use Case #2 – User-Centric Process

Client Profile:

  • A top 3 hearing aid tech company
  • Required end-user input for PMCF clinical performance
  • Little interest in study-based data collection methods
  • Access to end-users through distributors

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.

SMART-TRIAL 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.

Questions & Answers from Webinar

During our webinar on this topic, we received many questions that could apply to other manufacturers. For that reason, we have compiled all questions with answers in a single document. Some of the questions can be found below, and you can of course download the full Q&A document here.

1. How do you obtain clinical experience data?

Jón: There are multiple ways to obtain this data. This is just one type of data collected around the application of device in standard clinical practice. It’s not a specific data collection activity. It’s important to note though, that clinical experience data should be linked to a case/patient, as it needs to be objective. Subjective data does not bear enough scientific validity to be used to demonstrate clinical performance or safety.

Efstathios: Via direct connections with clinicians and clinics that use your CE marked device, under intended use ONLY, and record performance and clinical data. The key is to create a solid performance and safety panel and to create a good database from which you can do data analysis You can contact me on for more info.

2. What do you mean by clinical experience studies? Observational, non-interventional?

Jón: Clinical experience is not “interventional” – because you are gathering data/information on the clinical experience with a device that is already on the market being used in normal clinical practice for its intended use. However, this does not always have to be a study. For example, we at SMART-TRIAL offer SMART-TRIAL Cases, which can be used for “ad-hoc” data reporting on clinical experience out there in the market.

Efstathios: They are studies related to CE marked devices, used under intended use, and focused on monitoring ONLY medical device performance and safety without using patient info. The key is to create a solid performance and safety panel and to create a good database from which you can do data analysis.

3. What is an example of Clinical Experience?

Jón: There are multiple ways to obtain this data. This is just one type of data collected around the application of device in standard clinical practice. It’s not a specific data collection activity. It’s important to note though, that clinical experience data should be linked to a case/patient, as it needs to be objective. Subjective data does not bear enough scientific validity to be used to demonstrate clinical performance or safety.

Efstathios: If for example you provide your CE marked device to a medical doctor who will use your device as part of his clinical examination under intended use, and he/she records the device performance and safety accurately. Over time you create databases of clinical experience, and you can publish this as peer reviewed publication and use it as a reference in your CER as objective evidence that you do NOT need an investigation provided your data can support this.

4. How would you distinguish between clinical experience and usability?

Jón: Clinical experience is about the application of the device in practice, related to safety and performance. Usability is focused on the “use” of the device, as in a user’s experience, which may result in new information which informs the clinical performance or safety of the device.

5. Do you equate clinical experience data with real-world data?

Jón: Yes, these are both forms of collection of observational data for medical devices.

Efstathios: Absolutely YES. And a bonus is that you can publish this in peer review - that’s our approach.

6. Can dental implants be considered as WET devices? If yes, can we collect sufficient clinical data by surveys and clinical experience, without clinical investigation?

Jón: That depends completely on your devices CER. What gaps do you have in your clinical data? Have any of your devices been involved in safety issues?

Efstathios: Depends on the device. Agreed with Jón. How many years in service, established risk profile etc.

7. Can I use PMCF studies available on for my clinical evaluation?

Jón: Only if you can demonstrate access to the data, see Appendix IV about this requirement in the EU MDR. This also forms a component of your literature review and general surveillance.

8. Does a usability study need an ethics approval?

Jón: Assuming the medical device has CE marking, it depends on both the design of the usability study and the local country regulations... Please refer to the local ethics committees for reference

9. Which is the best tool suggested for a Survey?

Jón: There are many methods of conducting surveys, from personal interviews to electronic systems. When selecting a methodology, it is essential to meet the requirements of GDPR/HIPAA (as applicable), be able to prove survey integrity and to meet GCP and regulatory standards. For this reason, we strongly recommend that you only use a validated and compliant tool that is fit for this purpose. SMART-TRIAL Survey is a great option. It offers ISO 14155:2020 (GCP) compliance out of the box, as well as flexible ways of initiating the survey to end-users.

Efstathios: SMART-TRIAL and a great QMS/Template basis.

10. Is it sufficient for the PMCF to conduct surveys only, or is it absolutely mandatory to conduct clinical experience (observational) as well?

Jón: No, from what I have heard from Notified Bodies, surveys alone do not suffice because they lack the quantitative scientific basis for the data that’s collected. Conducting a survey to ask physician for their subjective opinions on clinical safety and performance is highly unlikely to be approved as a valid method, based on the fact that subjective data does not bear enough scientific validity. You need to gather patient specific data. Which can for example be achieved with SMART-TRIAL Cases, see “Use Case #1” in the webinar.

Download the full Q&A Document here

In Conclusion

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.

Need Help with PMCF Data Collection and Management?

Reach out to us and let us show you how SMART-TRIAL can significantly simplify your PMCF data gathering and regulation compliance