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Post-Market Clinical Follow-up (PMCF).

Comply with MDR requirements, collect reliable data and ensure the efficacy of your products in the long term.
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Current?

Do you use ongoing clinical data to keep the performance of your products up to date?

Compliant?

Do your PMCF activities meet all MDR and MEDDEV requirements for seamless product monitoring?

Effective?

Do you avoid unnecessary risks and ensure patient safety through clear findings in the product life cycle?

Ensure your product quality in the long term with a structured PMCF concept.

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Post-Market Clinical Follow-up (PMCF).

Safety and performance in medical technology and IVD.

Post-market clinical follow-up (PMCF) is an indispensable part of the product life cycle of medical devices and in-vitro diagnostics (IVD). According to MDR requirements, products that have already been approved must collect, analyze and update clinical data in order to continuously prove their safety and efficacy. We support medical device and IVD manufacturers in planning and implementing PMCF strategies to meet regulatory requirements and maintain patient safety.

Our services include PMCF planning and study design, systematic data collection and monitoring, detailed data analysis and the preparation of MDR-compliant documentation and reports.

Post-Market Clinical Follow-up (PMCF) - Sustainable safety in use.

Our proven methods and tools help you to effectively implement PMCF activities and reliably comply with regulatory obligations:

PMCF concept and protocol.

  • Development of a holistic PMCF strategy, tailored to product class and risk
  • Design of the study or observation formats (e.g. prospective studies, register data, retrospective analyses)
  • Integration of PMCF activities into your existing quality management system

Clinical data collection and monitoring.

  • Development of structured data collection processes and tools
  • Monitoring product-specific results and side effects on the market
  • Collaboration with users, clinics and research institutions

Continuous evaluation and reporting.

  • Systematic analysis of collected PMCF data (e.g. safety, efficacy, performance)
  • Updating your risk assessments, clinical evaluations and approval dossiers
  • Preparation for audits and inquiries from authorities

Case Studies - Successful PMCF in medical technology.

Post-Market Clinical Follow-up (PMCF) is a crucial process to ensure the safety and performance of medical devices after market launch

Challenge.

A manufacturer of portable medical monitoring devices needed to validate the performance of its product over an extended period of use.

Measures.

  • Development of a PMCF study with a focus on suitability for everyday use and user satisfaction.
  • Creation of questionnaires to collect user data and technical performance indicators.
  • Integration of monitoring software for continuous data acquisition during use.

Results.

  • Significant reduction in false alarms thanks to precise calibration of the sensors.
  • Improved user satisfaction through optimized user-friendliness.
  • Increased market acceptance due to proven long-term stability.

Success.

Thanks to the reliable data, the device was successfully launched in other markets.

Improve your PMCF strategy.

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Our PMCF service portfolio: Comprehensive support for your medical devices.

Continuous post-market surveillance of medical devices is crucial to ensure their safety and performance. Our PMCF service portfolio offers you comprehensive support in accordance with MDR requirements.
Our services include the planning and development of individual PMCF concepts that are specifically tailored to the characteristics and risks of your product in accordance with MDR Annex XIV, Part B. We integrate the PMCF activities into your existing quality management system to ensure seamless implementation.
Another focus is on conducting PMCF studies, in which we implement both prospective and retrospective data collection. By adhering to ethical and regulatory standards, we ensure that the integrity and credibility of the results are guaranteed.
Data collection is followed by systematic analysis of the collected PMCF data to assess the safety and performance of your product in real-world use. We identify and evaluate new or emerging risks and update the clinical evaluation and risk management documentation based on the PMCF results.
Our portfolio is rounded off by the preparation of comprehensive PMCF reports that comply with the requirements of the MDR and the guidelines of the Medical Device Coordination Group. This also includes support in preparing for audits and inquiries from authorities through complete and transparent documentation of PMCF activities.

Strengthen the safety of your medical devices even after approval.

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Related topics to Post-Market Clinical Follow-Up.

Post-Market Clinical Follow-up (PMCF) is only one part of the comprehensive monitoring of medical devices after market launch. The following topics optimally complement PMCF activities and support sustainable compliance and risk minimization

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