Post-Market Surveillance (PMS) & Post-Market Clinical Follow-up (PMCF) Services
Planning, Execution, and Reporting for Medical Devices
Post-market surveillance and post-market clinical follow-up are regulatory requirements that manufacturers must plan for before market access and maintain after the device is placed on the market. These activities generate the data, analysis, and records that regulators expect to see throughout a device’s commercial lifecycle.
AJW Technology Consultants works with manufacturers to establish PMS systems, carry out PMS and PMCF activities, and prepare the required outputs. This includes PMS plans, PMS reports, PSURs, PMCF plans PMCF evaluation reports, and clinical evaluation report (CER) updates.
PMS System Setup and Planning
PMS systems are established before market entry and then implemented after the device is launched. Notified bodies and regulatory authorities expect to see PMS procedures, PMCF plans, and related planning records as part of the technical file before granting market access.
AJW Tech develops PMS systems that define:
- Reporting timelines, including PMS report and PSUR intervals
- Connection between PMS outputs and clinical evaluation updates
- Data sources to be monitored (complaints, vigilance, literature, clinical data)
- Integration with CAPA, management review, and the broader QMS
- Roles and responsibilities for each PMS activity
- Criteria for evaluating post-market data
Ongoing PMS Activities After Market Entry
Once a device is on the market, manufacturers are expected to perform PMS activities on an ongoing basis. These include:
- Complaint handling and trend analysis
- Vigilance reporting and monitoring of field safety corrective actions
- Review of adverse event databases and recall notices
- Literature review for new clinical, safety, and performance data
- Analysis of post-market data against the device's benefit-risk profile
Each of these activities produces data that feeds into the manufacturer’s PMS records and regulatory reporting obligations. AJW Tech carries out these activities on behalf of manufacturers or works alongside internal teams to maintain compliance.
Post-Market Clinical Follow-up (PMCF) as Part of PMS
PMCF sits within the broader PMS system and focuses on collecting clinical data after market entry to confirm device safety and performance over time.
The data gathered through PMCF feeds directly into the Clinical Evaluation Report (CER). The PMCF evaluation report captures the methods used, findings, and conclusions from those activities.
Notified bodies expect PMCF plans to be in place before CE marking. Once the device is on the market, manufacturers carry out the planned activities and maintain the resulting records on an ongoing basis.
Required Outputs and Reporting
PMS and PMCF activities generate several records and reports:
1. PMS Reports
Document PMS activities, findings, and conclusions for each device.
2. Periodic Safety Update Reports (PSURs)
Required for higher-risk devices at defined intervals under EU MDR 2017/745 and EU IVDR 2017/746.
3. PMCF Evaluation Reports
Document PMCF methods, data collected, and clinical conclusions.
4. Clinical Evaluation Report (CER) Updates
ncorporate PMS and PMCF findings into the manufacturer’s ongoing clinical evaluation.
AJW Tech prepares each of these outputs based on the manufacturer’s PMS data and device-specific regulatory context.
How AJW Tech Performs PMS and PMCF Activities
AJW Tech uses internally developed and validated tools for key post-market surveillance activities, including regulatory database review and literature review, with traceable outputs that feed into downstream records.
1. PMS Database Search Tool
Used to run searches across multiple regulatory databases, including adverse event reports, recalls, and field safety notices, and generate traceable reports. These reports serve as direct inputs to PMS reports and PSURs.
2. Literature Search Tool
Used for post-market surveillance literature review through the PubMed database. The tool generates a traceable screening spreadsheet, aggregated inclusion and exclusion results, and a report output that serves as input to PMS Reports and PSURs. AJW consultants complete the literature analysis and conclusions before
delivery.
All outputs are delivered in Microsoft Word format for easy incorporation into PMS reports, PSURs, PMCF evaluation reports, and CER updates. Each output is prepared for direct editing and incorporation into downstream records, with analysis and conclusions completed by AJW consultants. Traditional approaches for literature review and post-market data analysis are also available.
When Manufacturers Typically Need PMS and PMCF Services
Manufacturers seek PMS and PMCF services at different points:
- Building a PMS system ahead of conformity assessment or submission
- Strengthening PMS processes before or after notified body audits
- Supplementing internal teams responsible for post-market obligations
- Completing overdue PMS reports, PSURs, or CER updates
- Expanding PMS coverage to new devices or markets
- Adding PMCF activities to an existing PMS system
Talk to AJW Tech About Your PMS Obligations
Whether you need PMS procedures and planning records in place before market authorization, ongoing PMS and PMCF activities after launch, or preparation of records such as PSURs, PMCF Evaluation Reports, and CER updates, AJW Tech performs the work and prepares the resulting deliverables.