--- title: "PMCF, Post-Market Clinical Follow-up | MedTech Terms" description: "Proactive collection of clinical data on a CE-marked device to confirm safety and performance. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Post-Market](/terms?cat=Post-Market) 6. / 7. Post-Market Clinical Follow-up [All terms](/terms) Post-Market [Regulated Pathways](/ecosystems/regulated-pathways)[Clinical Evidence](/ecosystems/clinical-evidence)[Post-Market & Safety](/ecosystems/post-market-safety)[Startup Lifecycle](/ecosystems/startup-lifecycle)PMCF # Post-Market Clinical Follow-up Proactive collection of clinical data on a CE-marked device to confirm safety and performance. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition PMCF is a continuous process under EU [MDR](/terms/mdr-reporting) Annex XIV Part B that updates the clinical evaluation throughout a device's lifecycle, using methods such as registries, surveys, or post-market studies. What the regulation says Under [EU Medical Device Regulation](/terms/mdr) ( [MDR](/terms/mdr-reporting)) 2017/745 Annex XIV Part B, Post-Market Clinical Follow-up (PMCF) is a continuous process that proactively collects and evaluates clinical data from the use of a CE-marked medical device. This process aims to confirm the safety and performance of the device throughout its expected lifetime, identify previously unknown side effects or contraindications, and ensure the continued acceptability of the benefit-risk balance. The PMCF plan and its findings are integral to the [clinical evaluation report](/terms/cer) (CER) and other [post-market surveillance](/terms/post-market-surveillance) documentation. ## What this means in practice PMCF plans and evaluation reports feed into the [CER](/terms/cer), [PSUR](/terms/psur), and [SSCP](/terms/sscp). A weak PMCF plan is a frequent [Notified Body](/terms/notified-body) audit finding under [MDR](/terms/mdr-reporting). ## Examples - A manufacturer conducts a post-market clinical study on a novel implantable device to gather long-term performance data and monitor for rare complications not observed during pre-market trials. - A company implements a survey for users of a diagnostic software to collect feedback on usability and identify any unanticipated performance issues in diverse clinical settings. - A manufacturer analyzes data from a national joint replacement registry to track the long-term survival rates and revision rates of its hip implant device. Common pitfalls - • Failing to establish a proactive and systematic PMCF plan is a common deficiency cited by Notified Bodies. - • Treating PMCF as a one-time activity rather than a continuous, iterative process can lead to non-compliance. - • Not adequately justifying why certain data collection methods, or an absence of clinical studies, are appropriate for a device is a frequent pitfall. - • Overlooking the need to update the PMCF plan and report based on new information or risk assessments can result in regulatory issues. - • Collecting data without a clear methodology or statistically sound basis undermines the validity of PMCF efforts. ## Frequently asked questions What is the primary objective of PMCF? The primary objective of PMCF is to proactively collect and evaluate clinical data from the use of a CE-marked medical device to confirm its safety and performance, identify new risks, and ensure the ongoing acceptability of its benefit-risk profile. How does PMCF relate to the Clinical Evaluation Report (CER)? What types of activities are typically involved in PMCF? ## Cross-references ### Part of A larger framework or document this term belongs to. - [ EU Medical Device Regulation(MDR) ](/terms/mdr) ### Precedes Comes before in a typical workflow or lifecycle. - [ Periodic Safety Update Report(PSUR) ](/terms/psur) ### Follows Comes after in a typical workflow or lifecycle. - [ Clinical Evaluation Report(CER) ](/terms/cer) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Post-Market Periodic Safety Update Report(PSUR) Periodic EU MDR/IVDR report summarizing post-market surveillance findings. ](/terms/psur)[ Post-Market Post-Market Surveillance(PMS) Activities to monitor device safety and performance after market release. ](/terms/post-market-surveillance)[ Clinical & Trials Clinical Evaluation Report(CER) Documented assessment of clinical data demonstrating EU MDR conformity for a device. ](/terms/cer) ### More in Post-Market · Same category [ Post-Market 5-Day Report Expedited FDA MDR for events requiring remedial action to prevent unreasonable risk of substantial harm. ](/terms/five-day-report)[ Post-Market Annual Report (PMA) Yearly report required for Class III PMA devices summarizing changes, complaints, and post-approval study status. ](/terms/annual-report-pma)[ Post-Market Customer Notification Letter Communication to users notifying them of a safety issue, corrective action, or important product information. ](/terms/customer-notification)[ Post-Market Electronic Medical Device Reporting(eMDR) FDA's mandatory electronic submission system for Medical Device Reports. ](/terms/emdr) Cited by Where this term appears across MedTech Terms. Ecosystems (4) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Clinical Evidence](/ecosystems/clinical-evidence) - [Post-Market & Safety](/ecosystems/post-market-safety) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 MDCG· 1 FDA· 2 1. [1 MDCG 2020-7 PMCF Plan Template Verified MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_7_guidance_pmcf_plan_template_en_0.pdf) 2. [2 FDA MAUDE Database Verified FDA · accessdata.fda.gov ](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm) 3. [3 FDA Recalls - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Post-market cybersecurity surveillance? We help MedTech teams stand up vulnerability monitoring, coordinated disclosure, and post-market reporting workflows. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Post-Market Acronym PMCF Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=pmcf) Learn in 60 seconds Card Lesson Quiz Proactive collection of clinical data on a CE-marked device to confirm safety and performance. - · PMCF plans and evaluation reports feed into the CER, PSUR, and SSCP. - · A weak PMCF plan is a frequent Notified Body audit finding under MDR. Remember this Watch out: Failing to establish a proactive and systematic PMCF plan is a common deficiency cited by Notified Bodies. Related terms - [Clinical Evaluation Report(CER) ](/terms/cer) - [Periodic Safety Update Report(PSUR) ](/terms/psur) - [Post-Market Surveillance(PMS) ](/terms/post-market-surveillance) You may also need Auto-suggested from Post-Market and shared keywords. - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [Post-Market Surveillance Plan ](/terms/pms-plan) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) [All Post-Market terms](/terms?cat=Post-Market) From the Blue Goat network Related resources and services on this topic. - [ Code Blue Real medical device cybersecurity incidents and their lessons. ](https://codebluechart.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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