Post-Market Clinical Follow-up (PMCF)

Post-Market Clinical Follow-Up (PMCF) – for medical devices

Post-Market Clinical Follow-Up (PMCF) is a proactive process for collecting and evaluating clinical data on medical devices after they have been placed on the market. As a key component of the Post-Market Surveillance (PMS) system, PMCF helps confirm the continued safety, clinical performance, and benefit-risk acceptability of a device throughout its lifecycle.

PMCF supports the identification of new or emerging risks, rare adverse events, and long-term performance issues that may not have been evident during pre-market evaluation. The findings contribute to ongoing clinical evaluation, risk management, and regulatory compliance under the EU MDR.

The PMCF process is guided by a PMCF Plan MDCG 2020-7, which defines the methods and activities for collecting clinical data, while the results are documented in a PMCF Evaluation Report MDCG 2020-8 that summarizes findings, conclusions, and any necessary corrective or preventive actions.

Purpose of PMCF

The main objectives of PMCF are to:

• Confirm the continued safety and clinical performance of the device.
• Verify that the benefit-risk ratio remains acceptable.
• Identify previously unknown risks, side effects, and contraindications.
• Detect rare or long-term complications through real-world clinical use.
• Support updates to clinical evaluation and risk management documentation.
• Ensure ongoing compliance with regulatory requirements.

By continuously monitoring clinical performance after market placement, PMCF helps manufacturers maintain up-to-date clinical evidence and ensure the ongoing safety and effectiveness of their devices.

Post-Market Performance Follow-Up (PMPF) - for IVD medical devices

Post-Market Performance Follow-Up (PMPF) MDCG 2022-2 is a continuous process for collecting and evaluating performance and scientific data on In Vitro Diagnostic (IVD) medical devices after they have been placed on the market. As an integral part of the Post-Market Surveillance (PMS) system, PMPF helps confirm the continued scientific validity, analytical performance, clinical performance, and benefit-risk acceptability of an IVD throughout its lifecycle.

PMPF supports the identification of new or emerging risks, performance limitations, changes in the state of the art, and rare or long-term issues that may not have been evident during the pre-market performance evaluation. The findings contribute to ongoing performance evaluation, risk management, and regulatory compliance under the EU IVDR.

The PMPF process is guided by a PMPF Plan, which defines the methods and activities for collecting relevant performance data, while the results are documented in a PMPF Evaluation Report that summarizes findings, conclusions, and any necessary corrective or preventive actions.

Purpose of PMPF

The main objectives of PMPF are to:

• Confirm the continued scientific validity, analytical performance, and clinical performance of the IVD.
• Verify that the benefit-risk ratio remains acceptable throughout the device lifecycle.
• Identify previously unknown risks, performance limitations, and potential misuse scenarios.
• Detect rare or long-term performance issues through real-world use.
• Assess the impact of changes in the state of the art, intended use, or target population.
• Support updates to performance evaluation, risk management, and PMS documentation.
• Ensure ongoing compliance with applicable regulatory requirements.

By continuously monitoring performance after market placement, PMPF helps manufacturers maintain up-to-date performance evidence and ensure the ongoing safety, performance, and effectiveness of their IVD devices.

MEDREG provide comprehensive Post-Market Clinical Follow-Up (PMCF) services for medical devices under EU MDR 2017/745 and Post-Market Performance Follow-Up (PMPF) services for IVD medical devices under EU IVDR 2017/746.