PMCF Studies for Medical Devices under EU MDR
REGHELPS designs and runs post-market clinical follow-up (PMCF) studies for medical device manufacturers: PMCF plans, clinician and user surveys, registry and real-world data analysis, observational studies and PMCF investigations to ISO 14155, through to the PMCF evaluation report and updates to your CER, PSUR and SSCP.
What is post-market clinical follow-up (PMCF)?
Post-market clinical follow-up (PMCF) is the continuous, proactive collection and evaluation of clinical data from a CE-marked device used in real patients, within its intended purpose. It is the clinical part of your post-market surveillance system under EU MDR 2017/745.
PMCF answers the questions your pre-market clinical evaluation could not fully settle: long-term safety, rare side-effects, performance in specific patient groups and real-world use. Its findings flow back into the clinical evaluation report (CER), risk management file, PSUR and SSCP, keeping your CE certificate supported by current evidence.
The 5 objectives of PMCF
MDR Annex XIV sets out what PMCF must achieve. Every PMCF plan should show how each objective is covered for your device.
The PMCF lifecycle: how PMCF works, step by step
PMCF is a loop, not a one-off project. Each cycle starts from the gaps in your clinical evaluation and ends by updating it.
PMCF methods: general and specific
MDCG 2020-7 splits PMCF into general methods that apply to most devices and specific methods that answer targeted clinical questions. Most Notified Bodies expect at least one specific method for Class IIb, Class III and implantable devices.
| Method | Type | Best used for | Typical duration |
|---|---|---|---|
| Literature and database monitoring | General | Tracking new evidence on the device, similar devices and the state of the art | Continuous |
| Complaints, vigilance and trend analysis | General | Signals of new or increasing risks | Continuous |
| Clinician and user surveys | Specific | Real-world performance, usability and side-effects with measurable endpoints | 3–6 months |
| Registries and real-world data | Specific | Long-term outcomes and large populations | Ongoing |
| Retrospective chart review | Specific | Fast outcome data from existing patient records | 4–8 months |
| Prospective observational PMCF study | Specific | Planned follow-up of defined endpoints in routine use | 12–36 months |
| PMCF investigation (Article 74) | Specific | Questions needing protocol-driven data, including extra procedures | 12–36 months |
Which PMCF method does your device need?
A simple decision flow we use with clients. The final choice always depends on your CER gaps, device risk and Notified Body expectations.
What goes into a PMCF plan
Annex XIV Part B lists the minimum content of a PMCF plan. We follow the MDCG 2020-7 template so your Notified Body can find everything quickly.
| Section | What it must show |
|---|---|
| General PMCF methods | How you gather clinical experience, user feedback and literature |
| Specific PMCF methods | Surveys, registries, studies or investigations, and how they are run |
| Rationale | Why the chosen methods are appropriate for your device and its risks |
| Link to CER and GSPR | The CER sections and safety and performance requirements each activity supports |
| Specific objectives | The clinical questions each activity will answer, with endpoints |
| Equivalent and similar devices | How data on equivalent or similar devices will be evaluated |
| Standards and guidance | Common specifications, harmonised standards and MDCG guidance applied |
| Timeline | A detailed, justified schedule of activities, analysis and reporting |
The PMCF evaluation report and what it updates
The PMCF evaluation report is part of your clinical evaluation and technical documentation. Its conclusions must flow into every linked document.
PMCF and reporting expectations by device class
PMCF intensity and reporting frequency increase with risk class.
| Class | PMCF expectation | Post-market reporting |
|---|---|---|
| Class I | PMCF with general methods, or a documented justification | PMS report, updated when necessary |
| Class IIa | PMCF proportionate to risk and evidence gaps | PSUR at least every two years |
| Class IIb | PMCF usually including specific methods | PSUR at least once a year |
| Class III and implantables | Specific PMCF methods almost always expected | PSUR, PMCF evaluation report and SSCP updated at least once a year |
From PMCF protocol to final report
As a scientific and research collective, REGHELPS does not stop at writing plans. We run the study end to end.
- 1
Gap analysis and objectives
StrategyWe review your CER, risk file and PMS data to define the clinical questions PMCF must answer.
- 2
Study design and protocol
ISO 14155We choose the method, endpoints and sample size, and write the protocol and PMCF plan.
- 3
Ethics and notifications
Article 74We prepare ethics submissions and Member State notifications where required.
- 4
Site and investigator selection
FeasibilityWe qualify sites and investigators and manage contracts and site initiation.
- 5
eCRF and data management
DataWe build the eCRF or survey tool and manage data quality throughout.
- 6
Recruitment and monitoring
ExecutionWe drive patient or respondent recruitment and run risk-based monitoring.
- 7
Safety reporting
VigilanceWe capture and report adverse events and device deficiencies on time.
- 8
Statistics and PMCF evaluation report
MDCG 2020-8Our biostatisticians analyse the data and we write the PMCF evaluation report.
- 9
CER, PSUR and SSCP updates
Close the loopWe integrate results into your clinical evaluation and post-market documents.
Common PMCF findings from Notified Bodies
End-to-end PMCF services
PMCF FAQs
Is PMCF mandatory for all medical devices?
Yes, PMCF is part of post-market surveillance for every device class under EU MDR (Article 61(11) and Annex XIV Part B). If you conclude PMCF is not needed for your device, you must justify that decision in the PMS plan, and your Notified Body will review the justification.
What is the difference between PMS and PMCF?
Post-market surveillance (PMS) is the overall system for collecting and acting on data once a device is on the market: complaints, vigilance, trends and more. PMCF is the clinical part of PMS. It proactively collects clinical data to confirm safety, performance and benefit-risk throughout the device lifetime.
What is the difference between a PMCF plan and a PMCF evaluation report?
The PMCF plan sets out what you will do: objectives, methods, timelines and how results feed the CER (MDCG 2020-7 template). The PMCF evaluation report presents what you found and your conclusions (MDCG 2020-8 template). The report becomes part of the clinical evaluation and the technical documentation.
When do I need a PMCF study rather than a survey?
When the clinical questions in your CER cannot be answered by literature, registries or user surveys, for example long-term safety, rare complications or performance in a specific patient group. A structured observational study, or a PMCF investigation under Article 74, then gives the robust data Notified Bodies expect.
Does a PMCF investigation need ethics approval?
A PMCF investigation of a CE-marked device used within its intended purpose follows ISO 14155 and national ethics rules. If it adds invasive or burdensome procedures for patients, the sponsor must notify the Member States concerned at least 30 days before starting, under MDR Article 74(1).
How often must PMCF be updated?
Continuously, as data comes in. For Class III and implantable devices, the PMCF evaluation report and the Summary of Safety and Clinical Performance (SSCP) must be updated at least once a year. For other classes, updates follow the PMS plan and the PSUR or PMS report cycle.
Are PMCF surveys acceptable to Notified Bodies?
They can be, if they are well designed: clear clinical objectives, validated questions, a defined population, adequate sample size and analysable endpoints. Simple satisfaction questionnaires are increasingly rejected, so survey design matters as much as the number of responses.
Can you run PMCF for devices already on the market or legacy MDD devices?
Yes. We assess the gaps in your current clinical evidence, design PMCF activities to close them and integrate the results into your CER, PSUR and SSCP. For well-established technologies, MDCG 2020-6 can allow more reliance on general PMCF methods.
Need a PMCF study that your Notified Body will accept?
Share your device, class and CER gaps using the form below and we'll propose a PMCF approach and budget.
