Post Market Clinical Follow up (PMCF) Documentation Consultancy
PMCF Documentation Consultancy for Medical Device Manufacturers
Independent PMCF Consultants
MDRcert writes and remediates post-market clinical follow-up documentation for medical device manufacturers under MDR. PMCF is the part of the clinical file that most often arrives as a placeholder: a plan that promises to monitor literature, and a report two years later that found nothing.
The obligation sits in Annex XIV Part B, which requires a continuous process to confirm safety and performance across the expected lifetime, to identify previously unknown side effects, and to check that the benefit-risk conclusion still holds. MDCG 2020-7 and MDCG 2020-8 give the plan and report templates that Notified Bodies expect you to follow.
PMCF is not optional by default. If you conclude it is not appropriate for your device, Annex XIV Part B requires that decision to be justified and documented in the post-market surveillance plan. An unjustified omission is a deficiency.
Methods Chosen for Evidence, Not Convenience
The weakest PMCF plans list every possible method and commit to none. The strongest ones name the specific residual clinical question the plan exists to close, then select the method capable of answering it.
Literature monitoring answers almost nothing on its own. If your clinical evaluation relied on equivalence, general literature will not confirm your own device performs as claimed, and a reviewer will say so. Registries, structured user surveys and prospective PMCF studies cost more and are sometimes the only defensible option.
We connect the output back where it belongs. The PMCF evaluation report feeds the clinical evaluation report under Article 61 and Annex XIV Part A, and it feeds the PSUR under Article 86. When those three documents carry different data cut-off dates or different conclusions, the contradiction is what gets found.
Assess
Current-State PMCF Gap Assessment
Plan
PMCF Plan Design and Method Selection
Build
Data Collection, Appraisal and Clinical Analysis
Submit
PMCF Evaluation Report Authoring
Maintain
Periodic Update and Cross-Document Alignment
What teams need before PMCF review cycles
Most PMCF deficiencies trace to one root cause: the plan was written without naming the clinical question it needed to answer. Without that, method selection is arbitrary, the report has no standard to be judged against, and the link back to the clinical evaluation cannot be made.
We start from the residual questions your clinical evaluation left open, then design the plan around closing them. Objectives and methods under MDCG 2020-7, appraisal criteria set before data collection, and a reporting structure that maps to MDCG 2020-8. The result is wired into the post-market surveillance system so that the PMCF findings reach the PSUR and the risk management file instead of stopping at the report.
For in vitro diagnostics the counterpart is post-market performance follow-up under Annex XIII Part B of IVDR. Our IVDR consulting service covers that side.
Is your PMCF evaluation report due or under review?
Core PMCF Documentation Coverage
Testimonials
Working with MDRCert for our MDR compliance audit was a game-changer. Their thorough risk management assessment helped us achieve Notified Body approval on the ...
Dr. James Rodriguez
MDRCert guided us through our complete IVDR transition with exceptional expertise. Their team identified critical gaps in our technical documentation and provid...
Sarah David
As a first-time manufacturer, the EU MDR felt overwhelming. MDRCert became our trusted partner, guiding us from initial strategy and risk management to final su...
Ben Smith
The gap analysis conducted by MDRCert was a game-changer. They identified critical vulnerabilities in our technical file before our notified body audit. Their a...
Thomas Wright
Implementing a compliant ISO 13485:2016 QMS seemed daunting. MDRCert provided clear, pragmatic guidance tailored to our small company’s needs. They didn&#...
Maria Rodriguez
MDRCert authored a comprehensive Clinical Evaluation Report for our Class IIb device. Their report was exceptionally thorough and meticulously structured, which...
David Chen
We engaged MDRCert for our full MDR transition strategy. Their team’s deep expertise, particularly their former notified body background, was invaluable. ...
Sarah Jenkins
Frequently Asked Questions About PMCF Documentation
These are the questions manufacturers most often ask when building or defending post-market clinical follow-up documentation. For the full range of regulatory support we offer, see our consulting services.
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