• EU MDR 2017/745 Compliant Solutions

Expert PMCF Survey Services for Medical Device Regulatory Compliance

Bridge clinical data gaps and maintain CE marking with scientifically robust, end-to-end Post-Market Clinical Follow-up survey solutions designed for Notified Body approval.

  • Level 4 Clinical Evidence
  • 100% NB Acceptance Rate
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Overview

What is Post-Market Clinical Follow-up?

Post-Market Clinical Follow-up (PMCF) is a critical component of a manufacturer’s post-market surveillance obligations under EU MDR (2017/745) and IVDR (2017/746).

PMCF activities are designed to proactively collect and evaluate clinical data on a CE-marked device to confirm ongoing safety, performance, and clinical benefit throughout its lifecycle.

Sora Lifesciences supports medical device and diagnostics manufacturers in designing, executing, and reporting PMCF surveys that are scientifically robust, regulator-ready, and aligned with notified body expectations.

Why PMCF Is Required Under MDR/IVDR

Under MDR/IVDR, manufacturers must demonstrate that:

 
  • The device continues to perform as intended in real-world clinical use
  • Identified and residual risks remain acceptable
  • No new safety signals or performance gaps emerge post-commercialization
  • Clinical evidence remains current, relevant, and sufficient

Important: For many devices (especially legacy devices), pre-market clinical evidence alone is no longer sufficient. Notified bodies increasingly expect active PMCF data generation, not just literature updates.

Common Challenges

Why Manufacturers Struggle with PMCF

Many medical device companies find PMCF activities challenging due to resource constraints, unclear requirements, and lack of specialized expertise.

o
Unclear NB Expectations

Notified bodies have varying and evolving expectations for PMCF activities, making it difficult to know what level of evidence will satisfy reviewers.

o
Poorly Defined Objectives

PMCF objectives that fail to close clinical evidence gaps result in wasted resources and data that doesn't address the real regulatory questions.

o
Low Physician Participation

Engaging busy healthcare professionals to participate in surveys is challenging without established relationships and proper incentive structures.

o
Non-Defensible Surveys

Surveys that are not clinically meaningful or methodologically sound cannot withstand NB scrutiny and may be rejected entirely.

o
Translation to Reports

Difficulty translating survey outputs into usable PMCF Evaluation Reports and CER updates that meet MDCG template requirements.

Our Role

We bridge regulatory requirements with real-world clinical practice, ensuring PMCF data is both collectable and compliant. Our expertise transforms PMCF from a compliance burden into a strategic asset for your clinical evidence portfolio.

Our PMCF Services

End-to-End & Modular PMCF Services

We offer end-to-end as well as modular service offerings across the PMCF/PMPF survey—you can choose all or any of the below offerings to suit your specific requirements.

 
PMCF/PMPF User Survey Plan

MDCG compliant PMCF/PMPF User Survey Plan Creation along with SAS plan and sample size determination for PMCF/PMPF user survey data collection.

  • Gap analysis & scope definition
  • Endpoint specification aligned to residual risks
  • Sample size justification (SAS plan)
  • Ethical & regulatory pathway mapping
  • Statistical analysis plan

Key Deliverable:

MDCG 2020-7 compliant PMCF Plan ready for NB review

Survey Questionnaire

We design highly robust survey questionnaires that capture critical post-market data through scientifically sound methodologies in professional grade survey platforms.

  • Validated question design
  • Clinical endpoint mapping
  • Patient-reported outcome measures
  • HCP experience capture
  • Multi-language adaptation

Key Deliverable:

Scientifically validated, regulator-defensible questionnaire

Survey Data Collection

RWE generated using online surveys programmed in professional grade market research survey platforms among authenticated empanelled healthcare professionals.

  • 100K+ global HCP network access
  • EMR/patient case form data capture
  • Real-time data quality monitoring
  • CFR Part 11 compliant EDC
  • Retrospective record-based collection

Key Deliverable:

Clean, validated dataset with full audit trail

PMCF/PMPF User Survey Report

MDCG compliant PMCF/PMPF User Survey Report Creation using the Excel/SPSS raw data and Excel Data Tables generated from the online surveys.

  • Full statistical analysis & interpretation
  • Safety & performance conclusions
  • State-of-the-art comparison
  • CER integration narrative
  • NB response support

Key Deliverable:

MDCG 2020-8 compliant PMCF Evaluation Report

Need the Complete Package?

Most clients engage us for end-to-end PMCF survey management. Our integrated approach ensures seamless handoffs, consistent methodology, and faster time-to-submission.

Discuss Your PMCF Needs

OUR METHODOLOGY

A Proven, End-to-End PMCF Survey Process

Our 7-step methodology ensures every PMCF survey is scientifically rigorous, regulatory-defensible, and designed for notified body acceptance from day one.

 
MDCG-Aligned Study Design

Every PMCF/PMPF engagement begins with a clearly defined user survey plan aligned to MDCG 2020-7 requirements.

    • Study objectives and rationale
    • Target study population and geographies
    • Sample size calculation with documented justification
    • Primary and secondary endpoints (performance, safety, off-label use)
    • Device grouping (variants, configurations, minimum samples)

This structured planning minimizes review queries and ensures traceability from objectives to outcomes.

Robust Respondent Screening

We implement a multi-layered screening framework to ensure only relevant, qualified users enter the study.

    • Country and region eligibility as per the PMCF/PMPF plan
    • Licensed and actively practicing status
    • Conflict-of-interest checks
    • Role and clinical relevance (physicians, nurses, allied HCPs)
    • Confirmed usage of the intended device / technology / brand
    • GDPR-compliant informed consent and confidentiality

Advanced cheater checks and randomized validation questions are embedded to protect data integrity.

Questionnaire Development

Questionnaires are designed to capture clinically meaningful, statistically robust outcomes while remaining practical for real-world users.

    • Clear mapping to primary and secondary endpoints
    • IFU adherence and off-label use assessment
    • Predominantly controlled, close-ended formats suitable for analysis
    • Device-specific configuration and usage context
    • Adverse event capture and safety signals
    • Logical flow and respondent ease to reduce bias and fatigue

All questionnaires are developed with input from regulatory, clinical, and analytical perspectives.

Secure Survey Programming & Execution

Surveys are programmed and hosted on a secure, professional-grade platform with built-in quality safeguards.

    • Logic checks and skip patterns
    • Internal QA before launch
    • Controlled release to authenticated respondents only
    • Pilot testing and client review
    • Optional multi-language deployment

This ensures accurate data capture across geographies and device variants.

Targeted Recruitment & Engagement

We leverage a verified global HCP panel and structured outreach to meet sample requirements efficiently.

    • Targeted email campaigns
    • Tele-calling follow-ups where required
    • Reminder workflows to reduce drop-outs
    • Incentives aligned with FMV guidelines

This balanced approach maximizes participation while maintaining compliance.

Stringent Data Quality Controls

All data undergoes multi-step validation before analysis.

    • Speeding and straight-lining detection
    • Data completeness and consistency checks
    • Open-ended response validation
    • Cross-verification with profile and practice data

Only clean, defensible datasets progress to reporting.

MDCG-Compliant Reporting

Final deliverables are structured to support technical documentation and notified body review.

    • Methodology and deviation documentation
    • Endpoint-wise results and stratification
    • Clear implications for CER, PMS, and risk management updates
    • Sample justification and respondent profiling
    • Safety, performance, and off-label insights

Outputs are analysis-ready and aligned with regulatory expectations.

Our Expertise

Therapeutic Areas & Device Types We Support

We bring deep domain knowledge across key therapeutic areas and device classifications, enabling clinically relevant and regulator-ready PMCF surveys.

 
Therapeutic Areas
Dental
Orthopaedics
Surgical
Interventional
In Vitro Diagnostics (IVD)
Device Types
Class IIa and IIb legacy devices transitioning to MDR
Class III devices transitioning to MDR
Remaining Class IIa, IIb, and III devices requiring ongoing PMCF

Why Partner With Us

Trusted Expertise in Medical Device Clinical Research

We combine deep regulatory knowledge with clinical research excellence to deliver PMCF surveys that satisfy the most demanding Notified Body scrutiny.

 

250+

PMCF Surveys Completed

100%

NB Acceptance Rate

100K+

Global HCP Network

28

EU Countries Covered

Former Notified Body Expertise

Our team includes former NB reviewers who understand exactly what assessors look for in PMCF documentation.

In-House Biostatistics

PhD-level statisticians design sampling strategies and perform rigorous analysis—no outsourcing delays.

Multilingual Global Reach

Native-language survey deployment across all EU member states with in-country clinical expertise.

Accelerated Timelines

Proprietary HCP database enables rapid recruitment, reducing typical survey timelines by 40%.

NB-Ready Deliverables

Reports formatted per MDCG 2020-8 template, designed for seamless CER integration and NB submission.

Therapeutic Expertise

Specialized experience in orthopedics, cardiovascular, IVD, dental, and Class III implantables.

Frequently Asked Questions

Common Questions About PMCF Surveys

Get answers to the questions we hear most often from medical device manufacturers navigating EU MDR compliance.

 

When is a PMCF survey sufficient versus a clinical investigation?
PMCF surveys are appropriate when your device has substantial pre-market clinical data and you need to confirm long-term safety and performance, monitor residual risks, or gather real-world evidence. Full clinical investigations are typically required for novel devices, Class III implantables with limited clinical history, or when the survey cannot adequately address identified clinical gaps. Our gap assessment will recommend the most appropriate approach for your specific situation.

 

How do you calculate sample size for PMCF surveys?
Sample size is determined based on the primary endpoints, expected effect sizes, and the statistical power required to detect clinically meaningful differences. We use established methods for proportions (for safety/performance rates) or means (for continuous outcomes). For rare adverse events, we apply exact binomial methods. All calculations are documented with justification in the survey protocol and reviewed by our biostatistics team.

 

Is ethical approval required for PMCF surveys?
Requirements vary by country and survey design. Generally, surveys involving only healthcare professionals about their clinical experience may not require ethics approval. However, surveys collecting patient-reported outcomes, accessing patient records, or involving direct patient participation typically require ethics committee review. We assess requirements for each target country and manage the submission process.

 

What distinguishes Level 4 from Level 8 evidence?
Level 4 evidence (per MDCG 2020-6) consists of structured surveys collecting patient-specific clinical outcomes, safety data, and performance metrics with proper methodology. Level 8 evidence is general user feedback or opinions without structured methodology. Notified Bodies increasingly reject Level 8 evidence as insufficient. Our surveys are designed specifically to generate Level 4 evidence that directly addresses your device's residual risks.

 

How long does a typical PMCF survey take?
Timeline depends on scope, sample size, and geographic reach. A focused single-country HCP survey typically takes 3-4 months from protocol finalization to final report. Multi-country patient outcome surveys may require 6-9 months. Our established HCP network enables faster recruitment than building site relationships from scratch—often reducing timelines by 40% compared to traditional approaches.

 

Can PMCF surveys address legacy devices lacking clinical data?
Yes, this is one of the most common use cases. Many devices certified under MDD have limited clinical data that doesn't meet MDR Article 61 requirements. PMCF surveys can efficiently generate real-world evidence on safety, performance, and clinical benefits to bridge these gaps—often more cost-effectively than retrospective clinical studies. We specialize in designing surveys that directly address the specific evidence gaps identified in your Clinical Evaluation Report.

 

What data management systems do you use?
We use CFR Part 11 and ISO 14155 compliant Electronic Data Capture (EDC) systems that provide audit trails, electronic signatures, and data integrity controls. Real-time data quality monitoring enables early issue identification. All systems meet the standards expected by Notified Bodies for clinical data capture.

 

How do you ensure survey responses are genuine and reliable?
We implement multiple validation mechanisms: HCP verification against professional registries, response consistency checks, statistical outlier detection, and response time analysis. For patient surveys, we use verified recruitment pathways through treating physicians. All methodologies are documented in the protocol for regulatory transparency.
 

Ready to Strengthen Your Clinical Evidence?

Schedule a complimentary consultation with our PMCF experts. We’ll review your clinical data gaps and recommend a tailored survey strategy for your MDR compliance needs.

 
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Response time: We respond to all inquiries within 24 business hours.