SciMed’s
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EU MDR Post-Market Surveillance: Building a Continuously Audit-Ready Evidence System
EU MDR has transformed post-market surveillance from a periodic compliance exercise into a continuously operating evidence system. Increasingly, Notified Bodies are not assessing individual PMS, PMCF, CER, Risk and PSUR documents in isolation, they are assessing the integrity of the evidence thread connecting them.
In this article, SciMed’s MD Alastair Selby explores why many otherwise well-written PMS systems fail under audit scrutiny, how evidence fragmentation creates operational and regulatory risk, and what a sustainable, continuously audit-ready MDR surveillance system looks like in practice.
From state-of-the-art monitoring and PMCF integration to lifecycle governance and benefit-risk consistency, he examines the operational realities manufacturers now face several years into MDR enforcement, and the practical steps required to maintain a coherent, defensible evidence ecosystem over time.
How to Build a Compliant PMS System
A compliant Post-Market Surveillance (PMS) system is not a reactive process. Under the EU Medical Device Regulation, it must proactively collect, analyse, and feed post-market data back into risk management, clinical evaluation, and corrective actions to demonstrate ongoing safety and performance throughout the device lifecycle.
UK PMS Regulations vs EU MDR
With the right updates, existing MDR-compliant systems can be efficiently adapted to meet the new MHRA requirements.