15 December 2020 - When to use Post-Market Clinical Follow-up (PMCF) Surveys under the European Union's Medical Device Regulation.

Do you have a clinical strategy for complying with Post-Market Clinical Follow-up (PMCF) Planning requirements?

In part one of this series, we discussed the variety of activities available for collecting PMCF data for Post-Market Surveillance (PMS) compliance under the European Union’s Medical Device Regulation (MDR).

In this installment, we take a deeper dive into when to use PMCF Surveys as a beneficial approach to collecting clinical data for medical device manufacturers.

With the May 2021 applicability deadline of the EU MDR fast approaching, many companies are finding it difficult to understand the differences between the potential activities and the best fit for their device(s) while ensuring the data is accurate and compliant. Meanwhile, those with legacy devices are finding that gathering PMCF data can be especially challenging due to insufficient or lack of clinical evidence on the manufacturer's own devices.

>> Access now: Top Ten Tips and Best Practices for PMCF Surveys Under EU MDR

When to use Post-Market Clinical Follow-up Surveys

PMCF Surveys have not been as common as literature searches as they differ drastically from traditional marketing surveys in that they need to satisfy the requirements of the MDR and pass a NB audit probe. This activity requires a sufficient protocol to ensure that adequate sample size methodologies, survey questions, GCP compliance, and survey deployment capabilities are employed.

Key advantages of PMCF surveys are the applicability to a broad range of devices across several risk classifications as well as the cost-effectiveness and timeliness to generate compliant PMCF data when compared to the other options of Registry/Hospital database studies and clinical investigations.

Unlike marketing surveys that focus on user experience related to satisfaction, PMCF Surveys should target a specific endpoint, such as a clinical or performance claim. The PMCF Survey should not be combined with a marketing survey because the survey respondent can lose focus easily if you try to cover too many diverse topics, resulting in less useful data needed to meet the requirements of the MDR. This is a dilemma for many companies who assume that Marketing and PMCF Surveys can be combined, especially when marketing holds the entire survey budget.

For most Class I, IIa, IIb non-implantable, and some non-implantable Class III devices, the use of surveys is a good option if developed using scientifically sound methodologies. Keep in mind, however, that surveys alone will not be appropriate for most implantable Class IIb- and Class III- devices due to the increased risk profile.

The development of compliant PMCF Surveys is a complex process and requires knowledge of the MDR and its intent, as well as knowledge of the device technology and its use in a clinical setting.

>> Access now: R&Q and RAPS On-Demand Webcast - Strategies for Successful PMCF Planning and Execution

Under the MDR, the level of scrutiny by NBs on PMCF is going to be significantly increased compared to the scrutiny under the current directives. This is evident starting with the MDR application stage where the adequacy of PMS and PMCF plans will be reviewed followed by conformity assessments of the Quality Management System (“QMS”) and Technical Documentation during which reviews of the processes and output therefrom (data) will be checked for alignment with the previously provided plans. It is important to be aware that the NBs are very likely to raise non-conformities where there are discrepancies between your plans and the actual PMCF activities.

Additionally, the NBs’ limitation on the number of rounds of review questions makes it especially prudent and vital for medical device manufacturers to develop processes that would generate robust and compliant data. NBs will also focus on compliance of PMCF reports including survey results to the requirements of Sufficient Clinical Evidence as referenced in MDR Article 61, Para 1, and defined in MEDDEV 2.7.1 Rev 4 as:

“…an amount and quality of clinical evidence to guarantee the scientific validity of the conclusions.”

Embedded in the term ‘scientific validity’ are concepts including the adequacy of study design and controls for bias, appropriateness and relevance of research questions, adequacy of sample sizes and statistical analyses, completeness of data, adequacy of the follow-up period, and appropriateness of conclusions based on objective evidence.

Additionally, for surveys to provide appropriate PMCF data for the device, device manufacturers will need to ensure the use of a compliant Electronic Data Capture (“EDC”) platform and generation of a compliant report.

Conclusion

Deciding if PMCF Surveys are right for your organization and device(s) takes much consideration and will require expertise to implement. Even though surveys may be simpler than studies/registries, they still take a lot of planning and precision.

Although these tasks may seem overwhelming, the R&Q EU MDR expert team has developed a PMCF Survey process that is systematic and flexible around medical device manufacturers’ needs. As part of an “end-to-end” PMS solution. Including the critical task of managing NB expectations, R&Q’s holistic approach is based on inter-dependent processes of Risk Management, Clinical Evaluation, and Post-Market Surveillance.

In particular, the approach includes identifying clinical gaps using data from CERs, PMS data and residual risks from risk management, development of a PMCF strategy taking into account considerations for products that currently bear the CE mark per MDCG 2020-6, and creating a PMCF plan per MDCG 2020-7 that is aligned with PMCF survey activities.

Based on the calculated sample size, the survey is deployed with subsequent data held in a compliant EDC platform with an integrated statistical package used for the data analysis, and a PMCF report is created per MDCG 2020-8.

Markedly, our solutions address the “sufficient clinical evidence” required to demonstrate EU MDR compliance. It is noteworthy that generating PMCF data for most organization’s entire portfolio will take time and a typical PMCF Survey will take about three to four months to complete. Efficiencies in survey completion time may be gained if it is possible to deploy multiple surveys at the same time.

Set against an EU MDR transition period of fewer than four years, many medical device manufacturers may be facing a large amount of risk. Therefore, it is advisable to address your Proactive PMS plans now so that you are not left scrambling to keep your device(s) on the market while the NBs are knocking at your door.

Having trouble understanding and interpreting all the new EU MDR Post-Market Surveillance requirements? R&Q has answers and we are available to help you with your transition to MDR compliance. Follow these links to learn more about how we can help in your Post-Market Surveillance and EU MDR plans and implementation.

>> Access now: On-Demand Webinar - PMCF Plans: How to create detailed, compliant, and business-balanced PMCF plans

>> Access now: On-Demand DEVICE L❤️VE Live! - PMCF Process in Action: Best Practices for MDR Compliance

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Sources:
[1] European Commission. DocsRoom. MDCG 2020-8 Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies. Published 23 April 2020. Accessed 1 August 2020. https://ec.europa.eu/docsroom/documents/40906

[2] European Commission. DocsRoom. MDCG 2020-7 Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies. Published 23 April 2020. Accessed 1 August 2020. https://ec.europa.eu/docsroom/documents/40905

[3] European Commission. DocsRoom. MDCG 2020-6 Regulation (EU) 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies. Published 23 April 2020. Accessed 1 August 2020. https://ec.europa.eu/docsroom/documents/40904?locale=en

[4] European Commission. DG Internal Market, Industry, Entrepreneurship and SMEs. Consumer, Environmental and Health Technologies. Health technology and Cosmetics. MEDDEV 2.7/1 revision 4: Guidelines on Medical Devices. CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC. Published June 2016. Accessed 1 August 2020. https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/en/renditions/native

[5] European Commission. ENTERPRISE AND INDUSTRY DIRECTORATE GENERAL. Consumer Goods. Cosmetics and Medical Devices. MEDDEV. 2.7.1 Rev.3: Guidelines on Medical Devices. CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES. Published December 2009. Accessed 1 August 2020. http://ec.europa.eu/DocsRoom/documents/10324/attachments/1/translations/en/renditions/native

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