Notified body official shares recommendations for successful PMCF plans

BARCELONA – Successful postmarket clinical follow-up plans (PMCFs) should be able to provide new information that was not previously known about a device, such as delayed hypersensitivity reactions or thrombosis, asserted Breda Kearney, clinical regulatory lead for BSI at the RAPS European Clinical, Risk, and Postmarket Surveillance Conference on 24 October.

She said that “PMCF studies are not just mandatory exercises to collect more data on the same known information.” Under a PMCF, sponsors collect and evaluate clinical data from use of the device after device approval.

Kearney also addressed how PMCFs differ from studies collected under the postmarket surveillance (PMS) system and outlined some common issues observed in PMCFs.

The Medical Device Regulation (MDR) requires device manufacturers to conduct PMCFs, and these plans are an “integral” part of the PMS system, she said. Collecting this data has been accorded a higher profile under MDR compared to previous directives. Kearney said there may be circumstances where certain devices may not need a PMCF, but manufacturers must provide justification for not submitting one.

Kearney also sought to distinguish the difference between a postmarket surveillance plan (PMS) and a PMCF. A PMS is the general system covering all data and experience obtained during the post market phase of the product lifecycle while the PMCF, which is part of the PMS, specifically addresses the collection of clinically relevant information concerning the device’s safety and performance.

Manufacturers may rely on user surveys, screen adverse events, and review the scientific literature review on outcomes, performance, side effects in developing the plan. The plan can also be derived from patient registries related to clinically relevant data.

“PMCF studies are not just mandatory exercises to collect more data on the same known information. These studies should be providing new information or answering a question on information we do not know,” Kearney said. This can include data on adverse events, such as delayed hypersensitivity reactions or thrombosis associated with the device.

Some common problems seen with PMCFs are poor study or survey design with too many variables, no controls, or small sample sizes. Or in some cases the protocol may lack detail or have unrealistic timelines. In other situations, there may be undefined or inappropriate research questions.

Other problems include failure to validate survey questionnaires or a poorly executed PMCF evaluation report where there is a “data dump” rather than a discussion of results with clear conclusions.

Kearney described an approach of how one manufacturer developed a PMCF for a vascular stent for treating angina. The device was equivalent to a legacy stent even though there are some slight technical differences.

The manufacturer decided to combine approaches and develop a PMCF clinical investigation to collect short term data and then use a registry to collect longer term data. This approach was decided as the most appropriate for the device, which was a high-risk class III implantable device where common risks are known to occur in the short-term and performance issues can occur in the long-term.

Notified body official shares recommendations for successful PMCF plans

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