PMCF Plan Template: How to Structure Objectives, Methods, Endpoints, Timeline, and Reports

Practical PMCF Plan template aligned with MDCG 2020-7 and EU MDR Annex XIV Part B — covering objectives derivation from CER gaps, method selection (registries, surveys, studies, literature), endpoint definition, sample size logic, schedule, triggers, PMCF evaluation report structure, and PMS integration.

Why a PMCF Plan Template Matters

Post-Market Clinical Follow-Up (PMCF) is a continuous process that updates the clinical evaluation and shall be addressed in the manufacturer's post-market surveillance (PMS) plan. Under EU MDR Article 61 and Annex XIV Part B, PMCF is not optional for most device classes — especially Class IIa, IIb, and III devices, and all implantable devices.

Notified Bodies increasingly issue nonconformities when PMCF plans lack traceability to clinical evaluation gaps, when objectives are vague, or when methods are not justified. This template provides a section-by-section structure aligned with MDCG 2020-7 and practical implementation guidance that goes beyond the template itself.

This is a template and implementation guide — not a general overview of PMCF. For the regulatory framework and strategy, see the companion PMCF guide.

PMCF Plan Structure Per MDCG 2020-7

Section A: Manufacturer Contact Details

Field	Content Required	Notes
Manufacturer name	Legal entity name	Must match EUDAMED registration
Address	Registered address	Include country code
Telephone	Contact number	Reachable during NB audit
Single Registration Number (SRN)	EUDAMED SRN	Required for all EU manufacturers
Authorized Representative	Name and address (if outside EU)	Per MDCG 2020-7 requirement
Plan number	Unique document identifier	e.g., PMCF-PLAN-YYYY-NNN
Date	Issue date	Document control date
Version	Current version number	Revision history tracked in table

Revision history table:

Version	Date	Section Changed	Description of Change	Author	Approved By
1.0	YYYY-MM-DD	All	Initial release	[Name]	[Name]
1.1	YYYY-MM-DD	C, E	Added registry activity; revised endpoints	[Name]	[Name]

Section B: Device Description and Specification

Field	Content Required	Example
Product/trade name	Device commercial name	OrthoFlex Total Knee System
Device model or type	Model identifier	OF-TKA-CR
General description	Physical description, principle of operation	Cruciate-retaining total knee replacement, cobalt-chromium femoral component, titanium tibial baseplate
Intended purpose	What the device is intended to do	Replacement of the knee joint to restore mobility and relieve pain
Intended user	Who uses the device	Orthopedic surgeons
Patient population	Who receives the device	Adults with end-stage osteoarthritis
Medical conditions	Conditions treated	Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis
Expected device lifetime	How long the device is expected to function	15 years
Indications	Specific indications for use	Primary total knee arthroplasty
Contraindications	Conditions where device should not be used	Active infection, insufficient bone stock
Warnings	Safety warnings	Not for use in patients with nickel allergy
Variants/configurations/accessories	All configurations covered	Cruciate-retaining (CR) and posterior-stabilized (PS) variants
CE certificate number	EU certificate reference	CE 1234-MDD-2024-001
CND code	Classification nomenclature	T26102
Device class	EU MDR classification	Class IIb, Rule 8
Novel features	Any novel technology or clinical procedure	Patient-specific instrumentation via pre-operative 3D planning

Section C: PMCF Activities

This is the core of the PMCF Plan. It must include both general and specific methods, the aim of each activity, the rationale for appropriateness, and known limitations.

General Methods (Annex XIV Part B, 6.2(a))

Method	Description	Aim	Limitations	Suitable For
Gathering clinical experience	Collection of clinical data from routine use	Confirm real-world safety and performance	Selection bias, incomplete reporting	All device classes
User feedback	Structured feedback from healthcare professionals and/or patients	Identify usability issues, off-label use	Self-selection bias, low response rates	All device classes
Screening of scientific literature	Systematic literature search per literature search protocol	Update state of the art; identify new safety signals	Publication bias, time lag	All device classes
Screening of other clinical data sources	Registries, EUDAMED vigilance data, competitor data	Broaden evidence base	Data quality varies by source	Class IIa and above

Specific Methods (Annex XIV Part B, 6.2(b))

Method	Description	Data Strength	Cost	Suitable Device Profile
PMCF clinical investigation	Prospective or retrospective clinical study per ISO 14155	Very High	High	High-risk implantable (Class III, IIb)
Manufacturer device registry	Company-sponsored patient registry	High	Moderate-High	Long-term devices, implants
National/public registry evaluation	Participation in or analysis of existing national registries	High	Low-Moderate	Joint replacements, cardiac devices
Real-world evidence (RWE)	Analysis of routinely collected healthcare data	Moderate-High	Moderate	Digital health, SaMD
Targeted user/patient surveys	Structured questionnaire to users or patients	Moderate	Low	Usability validation, satisfaction
Extended follow-up of pre-market study patients	Continuing to follow patients from the pre-market clinical investigation	High	Moderate	Devices with pre-market clinical data
Literature review update	Updated systematic review per MDCG 2020-7 methodology	Low-Moderate	Low	Mature technologies, low-risk devices

Activity Description Template

For each PMCF activity, document the following:

Field	Content
Activity ID	PMCF-ACT-001
Activity type	General / Specific
Method	e.g., Manufacturer device registry
Aim	What this activity is designed to achieve (must link to a specific PMCF objective)
Rationale for appropriateness	Why this method is suitable for the device's risk profile and residual uncertainties
Description of procedure	Step-by-step description of data collection and analysis
Data to be collected (quality and quantity)	Variables, endpoints, sample size target
Inclusion/exclusion criteria	Patient selection criteria
Timeline and milestones	Start date, interim analysis dates, end date
Known limitations	Incomplete follow-up, missing data, selection bias
Reference to CER section(s)	Which section(s) of the CER will be updated

Section D: References to Relevant Parts of Technical Documentation

Technical Documentation Section	Document Reference	Version	Relevance to PMCF
Clinical Evaluation Report	CER-YYYY-NNN	X.X	PMCF objectives derive from CER gaps
Risk Management File	RMF-YYYY-NNN	X.X	PMCF addresses residual risks
PMS Plan	PMS-PLAN-YYYY-NNN	X.X	PMCF Plan is a subset of PMS Plan
IFU / Labeling	IFU-YYYY-NNN	X.X	PMCF may identify labeling updates needed
Design Dossier / Technical File	TF-YYYY-NNN	X.X	Baseline device specifications

Section E: Evaluation of Clinical Data for Equivalent or Similar Devices

This section requires an assessment of whether clinical data from equivalent or similar devices informs the PMCF strategy.

Item	Content
Equivalent device(s) identified in CER?	Yes/No — if yes, list device(s) and CER equivalence section reference
Similar device(s) analyzed?	Yes/No — list devices, data sources, and key findings
How equivalent/similar device data informs PMCF	Identify safety signals, performance trends, or known complications that the PMCF should monitor
Limitations of equivalence data	Differences in materials, design, patient population, clinical practice

Section F: Reference to Applicable Common Specifications, Harmonised Standards, and Guidance Documents

Document	Reference	Applicability
MDCG 2020-7	PMCF Plan Template	Structural template
MDCG 2020-8	PMCF Evaluation Report Template	Reporting format
EU MDR Annex XIV Part B	PMCF requirements	Legal basis
ISO 14155:2020	Clinical investigation of medical devices	If PMCF includes clinical investigation
ISO/TR 20416:2020	Post-market surveillance for manufacturers	PMS framework
MDCG 2020-6	Sufficient clinical evidence for legacy devices	If applicable
Relevant device-specific CS or standards	e.g., ISO 5832 for implant metals	Device-specific
MDCG 2025-10	Post-market surveillance guidance (Dec 2025)	Updated PMS expectations

Section G: Estimated Date of PMCF Evaluation Report

Field	Content
Estimated report date	YYYY-MM-DD
Reporting interval	Quarterly / Semi-annually / Annually (justify based on risk)
Trigger criteria for early reporting	New safety signal, field safety corrective action, regulatory request, significant deviation from expected performance

Deriving PMCF Objectives from CER Gaps

The most common Notified Body nonconformity in 2026 is PMCF plans that do not trace back to specific clinical evaluation gaps. Use this structured approach:

Step	Action	Output
1	Review CER for residual uncertainties and limitations	List of gaps per CER section
2	Map each gap to a PMCF objective	One-to-one or many-to-one mapping
3	Define measurable acceptance criteria for each objective	Specific, measurable endpoints with thresholds
4	Select PMCF method(s) capable of generating data to address each objective	Justified method selection
5	Link objectives to GSPRs and risk control measures	Traceability matrix

Example: CER Gap to PMCF Objective Traceability

CER Gap / Residual Uncertainty	PMCF Objective	Method	Endpoint	Acceptance Criterion	GSPR Reference
Long-term (>5yr) performance data limited to 89 patients	Confirm implant survivorship at 10 years	Manufacturer registry	Cumulative revision rate	< 5% at 10 years (benchmark: National Joint Registry)	GSPR 1, 3
Limited data in patients >80 years	Monitor safety in elderly subgroup	Registry subgroup analysis	Adverse event rate in patients >80	No increase vs. overall cohort	GSPR 1, 9
No post-market data on newly introduced coating	Assess coating integrity over time	Targeted follow-up study	Coating delamination rate	< 1% at 5 years	GSPR 3, 10
Literature reports rare metal hypersensitivity with similar devices	Monitor incidence of hypersensitivity reactions	Literature review + registry	Hypersensitivity event rate	< 0.5% annually	GSPR 1, 13

Defining Endpoints and Sample Size

Endpoint Types for PMCF

Endpoint Type	Description	Example	Measurement Method
Safety endpoint	Rate of device-related adverse events	Implant revision rate	Registry data, complaint data
Performance endpoint	Measure of device functioning	Range of motion achieved	Clinical assessment, patient-reported outcome
Clinical benefit endpoint	Direct patient outcome	Pain reduction (VAS score)	Patient survey, clinical follow-up
Composite endpoint	Combination of safety and performance	Survivorship free from revision and complication	Registry or study data

Sample Size Logic

PMCF does not always require formal statistical powering. Justify sample size based on:

Approach	When to Use	Example
Formal power calculation	PMCF clinical investigation	80% power to detect 3% difference in revision rate at alpha=0.05
Rule of thumb (proportionate to risk)	Registry or survey-based PMCF	Minimum 100 patients for Class IIb; 250 for Class III
Saturation approach	Qualitative surveys	Continue data collection until no new safety signals emerge
Regulatory minimum	Some NBs specify expectations	Confirm minimum acceptable during pre-assessment dialogue

PMCF Schedule Template

Period	Activity	Milestone	Responsible	Deliverable
Year 1, Q1-Q2	Registry enrollment begins	50 patients enrolled	Clinical Affairs	Enrollment report
Year 1, Q4	Interim literature review	Literature review completed	Clinical Affairs	Updated literature summary
Year 2, Q2	Interim data analysis	First 100 patients at 12-month follow-up	Biostatistics	Interim analysis report
Year 2, Q4	User survey deployment	Survey completed	Clinical Affairs	Survey results summary
Year 3, Q2	Final data analysis	All patients at minimum 24-month follow-up	Biostatistics	PMCF Evaluation Report
Year 3, Q3	CER update	PMCF findings integrated into CER	Clinical Affairs	Updated CER

PMCF Evaluation Report Structure (MDCG 2020-8)

The PMCF Evaluation Report mirrors the PMCF Plan structure with results filled in:

Section	Content
A. Manufacturer details	Same as Plan
B. Device description	Same as Plan; update if device changed
C. Results of PMCF activities	For each activity: data collected, statistical analysis, findings, comparison to acceptance criteria
D. Integrated analysis	Overall assessment of all PMCF data combined
E. Conclusions	Safety confirmed? Performance confirmed? New risks identified? Benefit-risk still acceptable?
F. Actions	CER update needed? IFU revision? Risk management update? Field safety corrective action? PMS Plan update?
G. Date of next PMCF evaluation report	If ongoing

Acceptance Criteria Evaluation Template

PMCF Objective	Acceptance Criterion	Result	Met?	Action Required
Confirm survivorship at 10 years	< 5% revision rate	3.2% (n=142)	Yes	Continue monitoring
Monitor elderly subgroup safety	No increase in AE rate	4.1% vs 3.8% overall	Yes	Continue monitoring
Assess coating integrity	< 1% delamination at 5 years	0.7% (n=89)	Yes	None
Monitor hypersensitivity	< 0.5% annually	0.3%	Yes	Continue monitoring

Integration with PMS, Risk Management, and PSUR

PMCF does not exist in isolation. The following traceability chain is now expected by Notified Bodies:

Clinical Evaluation (CER)
    → identifies gaps/residual uncertainties
        → PMCF Plan addresses gaps
            → PMCF Evaluation Report analyzes results
                → Updated CER integrates findings
                    → Risk Management File updated
                        → PSUR summarizes benefit-risk
                            → PMS Plan triggers next cycle

Linked Document	PMCF Plan Reference	Update Trigger
CER	Section D	PMCF results change clinical conclusions
Risk Management File	Section D	New risks or changed risk levels identified
PMS Plan	PMS Plan Section on PMCF	PMS trend analysis identifies new signal
PSUR	PSUR PMCF section	Annual or per PSUR schedule
IFU / Labeling	Section D	Safety information needs updating
SSCP (Class III/IIb implantable)	Section D	Clinical data changes SSCP content

Common 2026 Audit Deficiencies

Deficiency	Frequency	Root Cause	Prevention
PMCF objectives not linked to CER gaps	Very High	Plan drafted without reviewing CER	Start from CER residual uncertainties
Methods not justified for risk level	High	Copy-paste from template without device-specific rationale	Risk-based method selection with justification
No acceptance criteria defined	High	Vague objectives ("confirm safety")	Specific, measurable criteria per objective
Schedule missing or unrealistic	Moderate	No timeline commitment	Milestone-driven schedule with owner
PMCF Report not integrated with CER	High	Report written as standalone document	Explicit CER update section in Report
No traceability to GSPRs or risk controls	High	Siloed clinical affairs function	Cross-functional review (clinical + RA + QA)
PMCF activities not proportionate to risk	Moderate	Low-risk methods for high-risk device	Match method strength to device classification

Key Takeaways

Structure the PMCF Plan using the seven-section MDCG 2020-7 template as a baseline, but add the device-specific depth that Notified Bodies expect in 2026
Derive every PMCF objective from a documented gap or residual uncertainty in the Clinical Evaluation Report — this is the most scrutinized element
Select PMCF methods proportionate to device risk and justify why each method is appropriate
Define specific, measurable acceptance criteria for every objective — vague statements like "confirm safety" will trigger nonconformities
Build the PMCF Evaluation Report structure before collecting data, so the analysis plan is pre-specified
Maintain bidirectional traceability: CER → PMCF Plan → PMCF Report → updated CER → Risk File → PSUR
Submit the first PMCF results to your Notified Body during the first surveillance audit after CE marking — delays signal noncompliance