PMCF plays a vital role in managing the complete lifecycle of medical devices and is a key component of the Post-Market Surveillance (PMS), required for medical devices under the EU MDR.

Our team of seasoned regulatory experts is well-equipped to meet your PMCF requirements to comply with EU MDR.

The PMCF procedure is a proactive, continuous method of collecting and assessing clinical data on the performance and safety of a medical device in use by a patient or clinician in a “real-world” setting.

The Annex XIV Part B of the MDR states that the objectives of the PMCF are to

  • Collect and evaluate clinical data relating to the performance and safety of a device bearing the CE marking when used and marketed within its intended purpose, throughout the device’s expected lifetime.
  • Identify unknown side-effects and monitor known side-effects and contraindications
  • Identify and analyse emergent risks
  • Ensure the continued acceptability of the benefit-risk ratio
  • Identify possible systematic misuse, or off-label use of the device, and verify the intended purpose is correct

All this data is essential for ensuring the continued safety and performance of the medical device throughout its lifecycle, when used by patients, caregivers and healthcare professionals in day-to-day practice.

Celegence can provide:

  • Guidance on your PMCF strategy

  • Design your PMCF Plan

  • Support end-to-end PMCF Survey process

  • Guidance on addressing Notified Body observations to meet regulatory compliance

  • Writing services related to PMCF Plan and Report, and other required documents

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Pharmaceutical Industry Regulatory Affairs - Celegence

How can Celegence help you strategize?

With the transition of MDD to MDR, medical device manufacturers are required to update their existing technical documentation for compliance. The Post-Market Surveillance (PMS) system for medical devices is an essential aspect in the clinical evaluation process and ensures the continuous safety and performance of medical devices after they are placed onto the market. PMCF serves as a crucial and complimentary component within the PMS framework. Our dedicated team of regulatory experts at Celegence can offer unparalleled PMCF support, aligning seamlessly with the complex requirements of the EU MDR. We will collaborate with you during every stage of your PMCF survey, from developing the survey design to conducting the survey, and analyzing the results that contribute to the PMCF Evaluation Report.

At Celegence, we understand the importance of continuous monitoring and evaluation of medical devices in the real-world context, and our team is adept at designing and implementing robust PMCF strategies tailored to your specific needs. We can assist you in developing a comprehensive strategy that integrates PMCF seamlessly into your broader PMS system. Elevate your regulatory compliance journey with us — where expertise meets excellence in PMCF support.

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How to Get Started with Celegence’s Post-Market Clinical Follow-up (PMCF) Guidance Services

To get started with Celegence’s Post-Market Clinical Follow-up (PMCF) Guidance services, please contact us today. We would be happy to discuss your specific needs and provide you with a quote.

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