,Freyr’s PMCF Servicesa
Post-Market Clinical Follow-Up (PMCF) is a critical component of the clinical evaluation process for medical devices and is required under the Medical Device Regulation (MDR) to ensure the continued safety and performance of a device throughout its expected lifespan. The data collection can include an online survey platform, comprehensive screener, closed-ended quant questionnaire, and high-quality data check.
Key Deadlines for PMCF Compliance
- December 31, 2027: All class III and class IIb implantable devices (excluding specific products like sutures and dental fillings).
- December 31, 2028: Class IIb non-implantable devices, class IIa devices, and class I sterile measuring and reusable surgical instruments.
Post-Market Clinical Follow-Up (PMCF) Surveys
These surveys are simple, timely, and cost-effective methods for collecting Real World Data (RWD). The data collected becomes an important part of technical documentation and contributes to PMCF Reports, Clinical Evaluation Reports (CER), and Risk Management Plans. The PMCF surveys offer advantages like providing flexibility, cost-effectiveness, and real-world relevance. The PMCF survey data collection process includes questionnaire preparation, fieldwork/data collection, statistical data analysis, programming and hosting, and raw data quality check.
The Mode of Data Collection Includes:
- Interviews: Personal interviews and telephone interviews.
- Questionnaires: Paper-based questionnaires and online questionnaires.
- Focused Group Discussion: Small groups, moderate sessions.
- Online Surveys: Email surveys and web-based surveys.
Key Requirements
PMCF Medical Device requirements are mandatory for Class IIa, IIb, and Class III medical devices. Also, they are applicable for medical devices which are CE certified based on equivalence, novel technology, lacking long-term safety data, or high-risk populations.
Is your medical device ready for safety and continuous monitoring? Contact us today for comprehensive PMCF services to make your medical device meet the regulatory requirements and maintain your medical device’s optimal performance throughout its lifecycle.
Post-Market Clinical Follow-up (PMCF) Surveys for Medical Devices
- Survey Plan Creation: MDCG compliant PMCF/PMPF User Survey Plan, SAS plan, and sample size determination.
- Survey Questionnaire: Design robust survey questionnaires to capture critical post-market data.
- Data Collection: Online surveys among authenticated healthcare professionals providing EMR or health record-based patient case forms data.
- Survey Report: Create PMCF/PMPF User Survey Reports using Excel/SPSS raw data and data tables.
- Assured compliance with recent applicable regulations.
- Team of qualified experts.
- Tailored solutions to your requirements.
- Regulatory resource management/staff augmentation services.
- Cross-functional inputs from medical device experts to comply with requirements.
