MEDICAL DEVICE COMPLIANCE, SIMPLIFIED

For MedTech start-ups, clinical evaluation under the EU MDR is no longer a box-ticking exercise - it’s a strategic part of product development. By planning early, leveraging existing evidence, and embedding regulatory thinking from day one, companies can turn compliance into a competitive advantage and a pathway to credible market entry.

This article outlines how clinical evaluation under the EU MDR can, in certain cases, be conducted without new clinical trials, and explains the regulatory pathways, evidence requirements, and role of PMCF in demonstrating safety and performance.

This article outlines the types of clinical data sources that are accepted, identifies common sources of non-compliance, and provides practical guidance for building a robust, compliant clinical evidence strategy under the MDR framework.

Under MDR Annex XIV, the CEP is your anchor document. Define scope, map data, integrate risk and PMS, and show foresight. A robust CEP reassures notified bodies and builds a sustainable compliance framework for product safety and performance.

MDR demands stronger clinical justification for legacy devices. Whether relying on WET status, Article 61(10), or targeted PMCF, manufacturers need structured Clinical Evaluation planning to demonstrate compliance and safeguard CE certification.

Is your Clinical Evaluation ready for MDR scrutiny?
This expert guide walks regulatory and clinical affairs professionals through the latest EU MDR expectations under Article 61 and Annex XIV—covering GSPR alignment, evidence standards, equivalence justifications, and audit-readiness strategies.

With the right updates, existing MDR-compliant systems can be efficiently adapted to meet the new MHRA requirements.