Post-Market Surveillance and Device PSUR Writing for Manufacturers
Pubrica writes post-market surveillance plans, PMS reports and device PSURs for medical device manufacturers. Our post-market device writers confirm which document your device class requires and how often, then prepare it to EU MDR Articles 83 to 86. Class I devices require a post-market surveillance report. Class IIa, IIb and III devices require a periodic safety update report, at least annually for class IIb and III and at least every two years for class IIa. You receive a PMS plan built to Annex III and reports with defined trend thresholds and a stated benefit-risk conclusion.
- The correct document for your class: PMSR under Article 85 for class I, PSUR under Article 86 for class IIa, IIb and III
- The correct reporting frequency: annually for class IIb and III, at least every two years for class IIa, and updated as necessary for class I
- A PMS plan that defines the surveillance system, built to Annex III and specifying the data, its sources, the analysis method and the thresholds for action
- Trend analysis with defined thresholds, because Article 88 trend reporting requires a threshold set in advance
- Sales volume and use population reported, as Article 86 requires, with each estimate supported by evidence
PMS plan to Annex IIIIncluded
Correct document for the classIncluded
Trend thresholds defined in advanceIncluded
Benefit-risk conclusion drawnIncluded
Reporting a favourable conclusion regardless of the dataNot offered
Sources → collected → trended → concluded → PSUR
- Correct document for the class
- Correct frequency, stated
- Thresholds set before the data
- Sales and use population evidenced
- Benefit-risk conclusion drawn from the data
Deliverables
Post-Market Surveillance Deliverables
The report is periodic, but the surveillance system that feeds it runs continuously, and notified bodies test that system.
Example from project scopingClass III and implantable device PSURs are submitted to the notified body through EUDAMED. Correct content in the wrong document, or on the wrong cycle, is a finding regardless of what the data shows.
Example from a PMS planA plan that lists sources without stating how each is analysed and who acts on the results does not describe a working system, and the system is what is audited.
Example from a trending methodTrends will be monitored and reported where a significant increase is observed.Threshold: complaint rate for device migration exceeding 0.8 per 1,000 units in any rolling quarter, against a baseline of 0.3. Exceeding it triggers an internal investigation within 10 days and assessment against Article 88 reporting criteria.
Example from a PSURWithout a denominator, a complaint count cannot be interpreted. Trend analysis also depends on this figure, so an unsupported estimate weakens the rest of the report.
The samples shown are illustrative and anonymised. Hover over a sample to replay it.
Compliance and Standards
Post-Market Surveillance Regulatory and Quality Standards
The obligations are set out in the regulation itself, by article and by device class.
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.
Clinical evaluation guidance (June 2016)
The structure notified bodies still assess against, read alongside MDCG 2020-13, which is the assessment template assessors use.
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 Post-Market Surveillance Documentation Process Works
We confirm the device class first, because the class determines which document is required and how often.
Device Class and Reporting Obligations
We confirm the device class and establish the correct document, reporting frequency and submission route before drafting begins.
PMS Plan Development
We build the PMS plan to Annex III, covering data sources, collection routes, analysis methods, trend thresholds and the actions each threshold triggers.
Data Collection and Analysis
Data is gathered across the reporting period and trended against the defined thresholds, and signals are investigated as they arise.
PMSR or PSUR Preparation
We write the PMSR or PSUR with the benefit-risk conclusion drawn and PMCF findings incorporated, and prepare it for EUDAMED submission where the class requires it.
Our Experts
Our Post-Market Surveillance 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
Post-Market Surveillance Service Packages
Pricing depends on device class, portfolio size and the state of the data you already hold.
PMS plan
For manufacturers setting up the surveillance system
Quoted per projectBased on class and portfolio
Delivery By scope
- ✓Sources identified with collection routes
- ✓Analysis methods per source
- ✓Trend thresholds defined and justified
- ✓Action triggers and owners
- ✓Written to Annex III
- ✓Linked to the PMCF plan
A well-specified plan reduces the cost of each later report, because it defines in advance how every data source will be analysed.
Deliverables Request a quotePMSR or PSUR
For each reporting cycle
Quoted per projectBased on class and data volume
Delivery To your cycle date
- ✓Correct document for the class
- ✓Data analysed against the plan
- ✓Sales volume and use population
- ✓PMCF findings incorporated
- ✓Benefit-risk conclusion
- ✓EUDAMED submission where required
Tell us the device class and the cycle date, and we will confirm the required document and deadline.
Deliverables Request a quotePortfolio programme
For manufacturers with many devices
Quoted per projectBased on device count and grouping
Delivery Scheduled
- ✓Device grouping assessed and justified
- ✓Shared PMS plan structure
- ✓Reporting calendar across the portfolio
- ✓Consistent trending across devices
- ✓Escalation route for signals
Device grouping can make portfolio reporting more efficient, but it must be justified in a way a notified body will accept.
Deliverables Request a quoteSend your device class and your last report, and we will check the document type, the reporting frequency and the trending method at no cost. These three checks do not depend on your data.
FAQs
Post-Market Surveillance and PSUR FAQs
If your question is not answered here, ask an expert. No quote is required.
Class I devices produce a post-market surveillance report under Article 85. Class IIa, IIb and III produce a periodic safety update report under Article 86.
They are different documents with different content requirements, and producing the wrong one is a finding regardless of the quality of the underlying surveillance.
Class IIb and class III at least annually. Class IIa at least every two years. Class I PMS reports are updated when necessary.
Class III and implantable device PSURs are submitted to the notified body through EUDAMED. The others form part of the technical documentation reviewed at surveillance.
They fall under different regulations. The pharmaceutical PSUR or PBRER sits under GVP Module VII and ICH E2C(R2). The device PSUR sits under MDR Article 86, with its own content requirements.
The two documents share a name but have different requirements, and experience with one does not transfer automatically to the other.
A threshold set in advance and justified against your own baseline and the state of the art, rather than one decided once the data is available.
Article 88 requires reporting of statistically significant increases in the frequency or severity of incidents that are not serious. Without a pre-set threshold, there is no basis for judging significance.
Related Services
Related Medical Device Regulatory Writing Services
Post-market surveillance data feeds every other document in the technical file.
1CLINICAL DOCUMENTSshared data
PMCF plan and reportFindings are reported in the PSUR. Clinical evaluation reportUpdated with surveillance findings.2RISK MANAGEMENTshared data
Device risk managementProduction and post-production information. GSPR checklistKeeps clinical evidence current.3PHARMACEUTICAL EQUIVALENTSseparate regulation
PSUR, PBRER and DSURFor medicinal products rather than devices. EU risk management planGVP Module V, for medicinal products.Request a Free Post-Market Surveillance Compliance Check
These three checks are the first an assessor makes, and none of them depends on your data.