Clinical and Medical Affairs
PMCF Services.
Generate clinical evidence in the post-market setting in a systematic and reliable manner. We help manufacturers establish comprehensive PMCF programs—including a PMCF plan, appropriate study designs (registers, surveys), and the final evaluation report.
Why is PMCF so challenging under the MDR?
The MDR has elevated PMCF (Post-Market Clinical Follow-up) from an often optional best practice to a mandatory requirement:
- MDR Annex XIV, Part B explicitly requires a PMCF plan for all products—at least as a formal justification in the event that it is determined that a PMCF is not necessary.
- PMCF activities must be planned strictly on a proactive basis. Simply waiting reactively for PMS signals is no longer sufficient.
- All PMCF results obtained must be incorporated into the regular CER update—without PMCF, there is effectively no up-to-date clinical assessment.
- For Class III devices and all implantable products, Notified Bodies review the PMCF plan and report with particular thoroughness and scrutiny.
Do you have a proactive PMCF plan for each of your approved products that systematically collects clinical data from the field?
Our PMCF services.
We plan, organize, and manage your PMCF programs from start to finish—from the initial strategic planning through to the final submission report.
PMCF Plan & Strategy
Development of a precise, product-specific PMCF strategy: What outstanding clinical questions need to be addressed? Which method (registry, survey, prospective study) is appropriate? We handle the entire process of developing the PMCF plan in accordance with MEDCOG 2020-7.
PMCF Registries & Surveys
Professional design and implementation of PMCF registries (protocol, EDC system, patient consent forms). We also design structured PMCF surveys to facilitate efficient, user-driven performance data collection in everyday clinical and practice settings.
Retrospective data analyses
Structured retrospective analysis of existing clinical data (customer feedback, complaints, results from post-marketing surveillance). We also offer systematic literature review as a PMCF method, provided that prospective studies are not strictly necessary.
PMCF Evaluation Report
Comprehensive, expert preparation of the PMCF Evaluation Report. We summarize all PMCF activities, derive clinical insights, draw well-founded conclusions, and prepare for seamless integration into the next CER update.
Frequently Asked Questions About PMCF & MDR.
What exactly is the difference between general PMS and PMCF?
PMS (Post-Market Surveillance) is the overarching system for the systematic collection and analysis of all information about a product (including complaints, safety reports, market feedback, and literature). PMCF (Post-Market Clinical Follow-up), on the other hand, is a specific component of this PMS system: It is the active, proactive plan for the targeted collection of purely clinical data from patients who are already using the product.
When does a product require its own dedicated PMCF studies?
Conducting proprietary, prospective PMCF studies is almost always essential when existing clinical evidence is insufficient to conclusively demonstrate long-term safety and performance. This applies in particular to entirely new products, Class III high-risk devices, implants, or whenever the Clinical Evaluation Report (CER) has identified unresolved clinical issues or residual risks.
What elements does a PMCF plan include in accordance with MDR requirements?
According to the official MEDCOG guidance, the plan must include: the general and specific objectives of the PMCF, a scientific rationale for the chosen methods, detailed information on the type and number of patients to be monitored, the analysis methodology, the duration and frequency of activities, and a clear timeline for the final PMCF Evaluation Report.
How strictly do Notified Bodies assess PMCF under the MDR?
Extremely rigorous. The Notified Body thoroughly reviews the PMCF plan for scientific and clinical adequacy and the PMCF Evaluation Report for completeness of content—and does so during every surveillance audit. Inadequate, purely pro forma PMCF activities or missing reports are currently among the most common causes of “major findings,” which jeopardize the entire CE certificate.
Additional expertise on clinical evidence in the market.
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