Study duration
3–7 yrs
Typical PMCF follow-up window
Dropout timing
Year 2
When most teams discover the gap
Regulatory driver
EU MDR
MDR 2017/745 PMCF requirements
PMCF Execution Model
Enroll · Retain · Follow up · Report
PMCF studies are not shorter versions of pre-approval trials. They are longer, lower-urgency, lower-resource, and structurally harder to execute than most medical affairs teams anticipate at the planning stage.
The devices are already approved. The regulatory pressure that drove pre-approval execution is replaced by a slower, rolling compliance obligation. Sites have moved on to new studies. Patients who enrolled with genuine interest in being part of a clinical program gradually lose their connection to it.
Most teams discover this around month 18 — when the first annual follow-up window approaches and a meaningful proportion of patients are difficult to contact, have stopped responding, or have site records that are no longer current.
The question is not whether PMCF retention will be difficult. It will. The question is whether the operational infrastructure was built to handle it.
See also: Post-Market Studies · Post-Market Compliance
These are the execution failures that turn a well-designed PMCF protocol into a compliance problem at year two or three.
Patients move, change phone numbers, and change email addresses. Without a process for periodic contact verification — not just at enrollment — study teams lose the ability to reach patients long before the follow-up window opens.
Post-approval studies compete with active pre-approval trials for site bandwidth. When a site has three higher-urgency studies running, PMCF tasks slip. Without a patient support layer that operates independently of site capacity, follow-up gaps accumulate.
Many PMCF designs have annual or biannual assessment windows with no structured patient contact between them. Patients who hear nothing for 11 months have effectively disengaged by month 12. Engagement requires continuity, not just visit windows.
PMCF studies involving wearable devices or connected technology face additional compliance risk: devices degrade, apps update, and patients stop wearing devices that no longer feel relevant to their daily life.
PMCF reports must demonstrate active data collection and justify any missing data. Without systematic follow-up documentation — attempts made, reasons for loss to follow-up, recovery steps taken — the report cannot satisfy regulatory review.
PMCF studies are often resourced at pre-approval study levels in year one, then quietly under-resourced as the novelty fades and the study drops in organizational priority. The resources needed to execute year five are rarely allocated at kick-off.
Teams that sustain strong PMCF retention build the operational infrastructure in at protocol design — not as a late add-on when retention problems emerge.
Related: Concierge-as-a-Service™
PMCF is required under EU MDR for Class IIa, IIb, and III devices, with the level of activity proportionate to risk classification. Class III and implantable devices face the most stringent requirements, including mandatory PMCF plans and periodic safety update reports.
Post-market surveillance (PMS) is the broader system for collecting and analyzing post-approval data. PMCF is the specific clinical data collection component within PMS. PMCF generates the clinical evidence that feeds into PSURs and the ongoing clinical evaluation.
Incomplete PMCF data creates regulatory risk. Notified bodies expect evidence of active follow-up effort and documented reasons for any data gaps. Studies with poor retention and inadequate documentation of follow-up attempts are most likely to face regulatory scrutiny or requests for additional data.
Delve provides the patient engagement, compliance monitoring, and documentation infrastructure that PMCF studies require to maintain data quality across multi-year follow-up periods.
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