Leveraging PMCF Surveys for EU MDR Compliance - Part 1

1 December 2020 - Getting started with 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 this two-part series, we will break down the variety of activities available for collecting PMCF data for Post-Market Surveillance (PMS) compliance under the European Union’s Medical Device Regulation (MDR). Then, we will take a deeper dive into how PMCF Surveys may be 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

Reactive vs. Proactive Post-Market Surveillance

Beginning with the source of the requirement, PMS plays a very active role in keeping medical devices on the market because this data is an input to the medical device risk management process. PMS data can be gathered in two different ways:

• ‘Reactive’: responding after an event; of which many types are ranging from complaints to those involving serious injury or, in an extreme case, where a serious injury or death has occurred known as ‘Vigilance’. These activities can be considered “passive” as they are largely data collection activities; and
  
  
• ‘Proactive’: endeavors meant to anticipate and curtail events before they occur. There are many types, such as user surveys, manufacturer-sponsored clinical registry studies, access and collation of pertinent product clinical data from hospital data management centers, and PMCF clinical studies.

More specifically, for Proactive PMS activities information is actively sought to gain insight and data into the real-world performance of the device. The MDR stipulates that PMCF shall be a continuous process that updates the clinical evaluation (part of Risk Management) and shall be addressed in the medical device manufacturer's PMS Plan.

To adopt a consistent approach, it is essential for manufacturers to proactively collect and evaluate clinical data from the use in or on humans of a device that bears the CE marking.

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

Approaches for Conducting Post-Market Clinical Follow-up Activities

The output of PMS - including PMCF activities that continuously update the clinical evaluation - should, in turn, be used to: confirm the overall safety and performance of a device throughout its expected lifetime, the continued acceptability of identified risks, and to detect emerging risks on the basis of factual evidence are aligned with the following:

• Intended use
• Instructions for use (IFU)
• Labeling; identify possible systematic misuse or off-label use
• Claims
• Technical documentation
• Risk management; to ensure continued acceptability of the benefit-risk ratio

The proactive collection of clinical data throughout the lifetime of the device is an incredibly daunting and expensive requirement. Device manufacturers must determine which PMCF activity or activities will be appropriate for their device type and classification to ensure the data generated will satisfy MDR requirements and Notified Body (NB) scrutiny in audits.

The four typical approaches for conducting PMCF activities are:

• Relevant literature review; 
• PMCF Surveys;
• Registry /Hospital database studies;
• Clinical investigations (in human subjects) or combinations thereof.

Where enough clinical evidence exists, device manufacturers should provide rationale for leveraging the relevant literature review and PMCF Survey activity options whenever possible due to the time and cost benefit.

Literature reviews have been commonly conducted formally as part of the clinical evaluation process for over a decade, making this option especially attractive and attainable. Consequently, many companies made this practice a permanent part of their process to align with the clinical evaluation requirements of the amendment to the MDD effective 21 March 2010 and the corresponding guidance on clinical evaluation of medical devices in MEDDEV 2.7/1 Rev 3, released in December 2009.

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

Understand Available Options Appropriate to Class of Device and Clinical Gaps

In the next installment of this series, we'll discuss when to use PMCF surveys and how to determine if it's right for your organization.

>> Access now: On-Demand RQM+ Live! - PMCF Process in Action: Best Practices for MDR Compliance

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Source:
[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