POST-MARKET SURVEILLANCE OF MEDICAL DEVICES

STAGES IN THE POST-MARKET SURVEILLANCE

Under Medical Device Regulation (EU 2017/745), post-market surveillance clinical data of medical devices should be collected by proactive (before happening) and reactive (when available) methods per articles 83-90. Additional information is also available in Annex XIV, Section B.

Post-market surveillance begins with the Post-Market Surveillance Plan (PMS-Plan). In the plan, the objectives (scope), data sources, responsibilities, details of surveillance methodology, and review criteria/frequency must be explained. Documents should be kept up-to-date and signed.

POST-MARKET SURVEILLANCE (PMS) PLAN

The PMS Plan is based on specific objective questions based on the device’s intended use, risks, and clinical benefits. According to these questions, the preclinical, literature, adverse events and sales history, and clinical follow-up data are collected and analyzed.

POST-MARKET CLINICAL FOLLOW-UP (PMCF) PLAN

The Post-Market Clinical Follow-up Plan (PMCF-Plan) can be arranged as qualitative or quantitative studies according to the objective of the Post-Market Surveillance Plan. PMCF surveillance methods can be general or specific methods or both. A justification for surveillance methodology should be made.

PMCF ACTIVITIES

The established method for PMCF surveillance is justified and carried out according to the PMCF Plan. Survey studies, continuation studies of clinical investigation studies, and real-life evidence studies are among these activities.

DATA ANALYSIS

The PMS/PMCF data can be categorical or numerical. Results should be interpreted by a statistical analysis method.

REPORT (PMS, PMCF, PSUR)

Unbiased data collected from sources are analyzed according to data type and quality. As a result of the analysis, deviations, emergent hazardous situations, and undesirable side effects must be identified. According to the risk class of the devices, PMS Report or PSUR (risk class IIa and higher medical devices) should be presented. A conclusion based on the benefit/risk ratio in PSUR should be clearly stated. The manufacturers are obliged to run Post-Market Clinical Follow-Up activities on their medical devices.

DATA TRANSFER

Conclusions that are made through Post-Market Surveillance or Clinical Follow-Up activities are transferred to the Clinical Evaluation and Risk Management Process.

WHAT CAN WE DO FOR YOU?

Regulatory-compliant standardized operating procedure for Post-Market Surveillance
Plan and Report Templates for PMS, PMCF and PSUR
Determining objectives of the Post-Market Surveillance activities
Designing device-specific PMCF studies
Analysis of the Post-Market Clinical Data