PMCF Plans and Evaluation Reports for Device Manufacturers
Pubrica writes post-market clinical follow-up (PMCF) plans and evaluation reports for medical device manufacturers. Our post-market device writers prepare the PMCF plan to MDCG 2020-7 and the evaluation report to MDCG 2020-8, design the surveys and registries that collect the data, and feed the findings back into your clinical evaluation and risk file. Under MDR, PMCF is presumed to apply, so each plan is aimed at the evidence gaps your clinical evaluation report named, and any justification for non-applicability is specific to the device.
- Written to the MDCG templates: 2020-7 for the plan and 2020-8 for the evaluation report, which notified bodies assess against
- Aimed at the gaps named in your CER, because PMCF that collects unrelated data does not close them
- Surveys designed to produce usable evidence, with a defined population, defined endpoints, a meaningful response rate and the analysis planned in advance
- Non-applicability justified only where it genuinely applies, which is rare and must be argued with device-specific evidence
- Findings fed back into the CER and the risk file, so that the PMCF report informs the documents upstream
Plan to MDCG 2020-7Included
Surveys and registries designedIncluded
Evaluation report to MDCG 2020-8Included
Findings fed back to CER and risk fileIncluded
Justifying PMCF as not applicable without groundsNot offered
CER gaps → plan → collected → evaluated → fed back
- MDCG 2020-7 and 2020-8 templates
- Aimed at the named evidence gaps
- Surveys designed for usable data
- Non-applicability argued with evidence
- Findings fed back upstream
Deliverables
PMCF Plan and Report Deliverables
PMCF exists to close specific evidence gaps, so each plan names the gaps it addresses and the activity that addresses each one.
Example from a PMCF planGeneral PMCF survey of users to confirm ongoing safety and performance.Objective 1: quantify the rate of device migration beyond 24 months, identified in the CER as unsupported by current evidence. Method: registry follow-up of 200 implanted patients at 24 and 36 months. Acceptance criterion: migration rate below the state-of-the-art benchmark of 4%.
Example from a survey designA user satisfaction survey with a 6% response rate and no denominator does not answer a regulatory question. It is the most common form of PMCF and the least useful.
Example from a justificationWe write justifications that can be supported by the evidence. We do not write unsupported justifications, because they become findings against the manufacturer.
Example from a PMCF reportA PMCF report that concludes that no changes are needed anywhere is likely to be read as a formality. Feeding the findings back into the file is the regulatory purpose of PMCF.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
PMCF Regulatory and Quality Standards
Notified bodies assess PMCF documentation against the published MDCG templates.
PMCF plan and report templates (assessed structure)
MDCG 2020-7 is the PMCF plan template and MDCG 2020-8 is the PMCF evaluation report template. Departing from them is possible but must be justified.
Medical Device Regulation (regulation)
Article 32 for the SSCP, Articles 83 to 86 for post-market surveillance, Annex I for the general safety and performance requirements, Annex II for technical documentation and Annex XIV for clinical evaluation and PMCF.
Risk management for devices (with ISO/TR 24971:2020)
Sets out risk management as a lifecycle process: hazard identification, risk estimation and control, overall residual risk acceptability, and production and post-production information fed back into the file.
Quality management (cert. H3CR9TCU20251212INDQM10N)
Our quality management system governs how each project is run, recorded and released.
Responsible Use of AI
Responsible Use of AI in Regulatory Writing
Regulatory reviewers trace each decision back to its evidence and to a named individual. For this reason, source traceability takes priority over speed in our regulatory writing, and every statement must be traceable to its source.
Why We Do Not Publish an AI Accuracy Figure
Accuracy figures for AI tools are usually reported by the companies that sell them.
Pubrica therefore does not quote a self-generated accuracy figure, because it would carry the same conflict of interest. Instead, we tell you which tool was used on your project, at which stage, and what a specialist changed afterwards.
Methodology
How Our PMCF Plan and Report Writing Process Works
The process starts with the clinical evaluation, because that is where the evidence gaps are named.
Evidence Gap Identification from the CER
We identify the residual uncertainties in the clinical evaluation and turn them into specific, answerable PMCF objectives.
PMCF Plan Development
We select a method for each objective, such as a registry, survey, study or literature surveillance, and set criteria, timelines and sample sizes to MDCG 2020-7.
Data Collection
We design the instruments, specify the analysis in advance and collect data in a form that answers each objective.
Evaluation and Feedback to the CER
We write the evaluation report to MDCG 2020-8 and carry the findings into the CER, the risk file and, where warranted, the labelling.
Our Experts
Our PMCF Writing Team
A named team of regulatory specialists stays with your project from scoping to delivery. Your project coordinator introduces each team member by name before work begins.
Writes the document against the governing template and regulatory guidance, keeps every statement traceable to its source data, and maintains the version history and comment log through each review round.
Reviews the clinical and scientific content for accuracy and confirms that each conclusion is supported by the data. Each expert is matched to your therapeutic or device area.
Checks that statistical methods, tables and conclusions are consistent with the analysis plan, and reviews how the data are presented before the document reaches regulatory review.
Performs an independent check of the final document against source data, the template and the applicable regulatory checklist. Findings are logged and resolved before delivery.
Packages
PMCF Service Packages
Pricing depends on device class, the number of evidence gaps to close and the methods they require.
PMCF plan
For manufacturers starting the post-market cycle
Quoted per projectBased on class and number of gaps
Delivery By scope
- ✓CER gaps turned into objectives
- ✓Methods chosen per objective
- ✓Acceptance criteria and timelines
- ✓Sample size reasoning
- ✓Written to MDCG 2020-7
Where PMCF is genuinely not applicable, we will advise you and write the justification, provided the evidence supports it.
Deliverables Request a quoteSurvey or registry design
For projects that require data collection
Quoted per projectBased on method and population
Delivery By scope
- ✓Population and endpoints defined
- ✓Instrument designed and piloted
- ✓Distribution and response strategy
- ✓Analysis specified in advance
- ✓Data handling and privacy addressed
The response rate determines whether a survey produces evidence, so we plan for it in the design.
Deliverables Request a quotePMCF evaluation report
For projects where PMCF data has been collected
Quoted per projectBased on data volume and objectives
Delivery By scope
- ✓Data analysed against the stated criteria
- ✓Conclusions per objective
- ✓Written to MDCG 2020-8
- ✓CER and risk file impact assessed
- ✓Labelling implications identified
Many reports omit the impact assessment, which is the section that shows how the PMCF findings were used.
Deliverables Request a quoteSend your CER and we will identify its evidence gaps at no cost, so you can see what PMCF needs to address before any activity is designed.
FAQs
PMCF Plan and Report FAQs
If your question is not answered here, ask an expert. No quote is required.
Only with a specific, device-level justification. MDR presumes PMCF applies, and a general statement about long market history or low risk class is not sufficient.
Where PMCF genuinely does not apply, we will write the justification. Where it does apply, an unsupported justification will be questioned at notified body review.
PMCF can include registry participation, post-market studies, structured surveys of users or patients, device-specific literature surveillance and analysis of real-world data, provided each activity is aimed at a named gap.
Routine complaint handling and vigilance are post-market surveillance activities, not PMCF. Presenting them as PMCF is a common deficiency.
Usually because they collect satisfaction data rather than evidence, have no defined denominator and have no acceptance criterion stated in advance.
A survey that answers a named objective, with a stated criterion and a usable response rate, is a different instrument from a feedback form, even though both are called surveys.
At the frequency your plan sets, justified by device class and risk, and aligned with the PSUR cycle: annually for class IIb and III, and at least every two years for class IIa.
The PMCF plan and the PSUR schedule should be designed together, since the PSUR must report the main PMCF findings.
Related Services
Related Clinical Evaluation and Post-Market Services
PMCF addresses the evidence gaps identified in the clinical evaluation and links to the wider post-market documentation.
1SOURCE OF THE EVIDENCE GAPSupstream
Clinical evaluation planIdentifies the evidence gaps. Clinical evaluation reportUpdated with PMCF findings.2POST-MARKET FRAMEWORKMDR Articles 83 to 86
PMS and device PSURArticles 83 to 86. Device risk managementUses production and post-production data.3DATA COLLECTIONclinical studies and data
Clinical trial supportSupport for post-market studies. Medical data collectionRegistry and real-world data collection.Request a Free Evidence Gap Review of Your CER
PMCF should address the evidence gaps already identified in your clinical evaluation report. We will identify them for you at no cost.