Post-Market Clinical Follow-up (PMCF)

Pre-market

In the pre-market phase, collecting ample evidence to validate the safety and performance of your device is key. That way you ensure the intended use and claims are supported by robust clinical data while mitigating associated risks as far as possible.

Post-market

In the post-market phase, PMS involves setting up mechanisms for the continuous collection of safety and performance data from real-world use. PMS activities can be reactive (vigilance, complaints), proactive (PMCF), or a combination, ensuring benefits continue to outweigh risks.

Strategic planning

PMCF plans tailored to your device, market, and regulatory needs.

Medical writing

High-quality PMCF documentation (plans, reports, literature reviews, surveys).

Clinical operations

Full-service CRO support for PMCF studies, including site management and monitoring.

Data collection

Surveys, registry evaluations, and real-world evidence generation.

Regulatory expertise

Guidance on PSURs, SSCPs, and integration with your Clinical Evaluation Report (CER).

PMCF is a continuous process of collecting and evaluating clinical data from the actual use of your CE-marked device. It's a regulatory requirement under the EU MDR and applies to all devices, including legacy products.

Common PMCF activities include either General Methods or Specific Methods. The right mix depends on your device's risk class, clinical history, market presence, and access to users or patients.

Literature reviews: An ongoing review of published scientific literature is a core PMCF activity. It involves systematically analyzing publications related to the device or similar/equivalent devices to gather evidence of safety, performance, and identify emerging risks. This is the minimum required PMCF activity for all devices, regardless of risk class, and should ideally be conducted annually. It is efficient, requiring few resources and being simple to complete, though it has limitations when using data from equivalent devices.

User feedback: A recognized PMCF activity aimed at gathering real-world insights into device performance, safety, and usability. Collected through structured surveys, interviews, or field reports, it helps identify emerging risks, confirm known safety profiles, and support benefit-risk assessments. Its main advantages include low resource requirements and ease of implementation, making it especially useful for lower-risk devices.

Case reports: A practical, cost-effective, and accepted PMCF method, especially for lower-risk devices. They involve collecting real-world clinical data from individual patients in routine practice. Sales representatives or field staff can gather basic information directly from physicians, requiring minimal manufacturer effort. When planned and documented in the PMCF plan, case reports offer valuable insights into device performance, safety, and usability.

Safety database searches: An important PMCF activity aimed at monitoring safety post-market. By reviewing public regulatory databases like FDA MAUDE, MHRA, or Eudamed, manufacturers can identify unreported adverse events, emerging risks, or misuse, helping maintain an up-to-date benefit-risk profile. These searches are efficient and low-cost, useful for spotting trends across large populations and benchmarking against similar devices.

PMCF surveys: A structured and efficient method for collecting real-world feedback from healthcare professionals, patients, or customers. Their primary purpose is to support ongoing clinical evaluation by identifying emerging risks, confirming known issues, and assessing the benefit-risk profile. High-quality surveys can help bridge gaps in clinical evidence and, in some cases, reduce the need for more resource-intensive clinical investigations. Patient-focused surveys, when designed to prospectively capture clinical and patient-reported outcomes, can be considered high-quality clinical data.

PMCF cohort studies: A structured way to collect real-world clinical data after market approval, especially for higher-risk or innovative devices. Their main purpose is to confirm ongoing safety and performance, particularly when long-term outcomes or specific clinical questions remain. These studies offer high-quality, device-specific data and allow for longitudinal follow-up, helping detect delayed complications and support clinical evaluation updates.

Investigator-initiated studies: Clinical studies led by independent researchers—such as physicians or academic institutions—rather than the device manufacturer. As a PMCF activity, they aim to generate real-world data to support ongoing evaluation of a device's safety, performance, and benefit-risk profile, especially in new indications or patient groups not covered in pre-market studies. A major advantage is their ability to provide valuable clinical evidence at relatively low cost to the manufacturer.

PMCF registries and interventional studies: Robust methods for collecting post-market clinical data to confirm ongoing safety, performance, and benefit-risk profile. They address residual risks, long-term outcomes, or specific clinical questions—especially for high-risk or innovative devices. Registries systematically collect real-world data from patients across multiple sites and over time, while interventional studies provide high-quality prospective data with predefined endpoints.