Process and Planning Are Key to Successful EU MDR PMS Compliance

Leave a Comment / EU MDR/IVDR, Focus Article, literature review, Medical Device, MedTech, nonconformances, off-label, PMCF, PMPF, PMS, poat market surveillance, PRRC, Quality/Regulatory, RC - EU MDR and IVDR, RC - Medtech Regulatory Resource Center / By

Process and Planning Are Key to Successful EU MDR PMS Compliance     In spite of continuing delays to implementation deadlines for Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), the requirements regarding Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), Post-Market Performance Follow-up (PMPF), and Person Responsible for …

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