Industry
Medical Devices Industry
ISO 13485, EU MDR, IVDR and FDA quality system audit services for medical device and IVD manufacturers, navigating regulatory transitions, Notified Body requirements and post-market compliance obligations.
The Regulatory Environment
The medical device regulatory landscape in Europe has undergone the most significant change in a generation. The full application of EU MDR 2017/745 and the ongoing transition to IVDR 2017/746 have fundamentally increased the compliance demands on device manufacturers, in clinical evidence, quality management, post-market surveillance, UDI implementation and economic operator obligations.
Many device manufacturers continue to manage the MDR transition as a documentation exercise rather than a compliance programme. The result is technical documentation that satisfies the letter of MDR requirements but does not reflect genuine clinical evidence or functional post-market surveillance systems. Notified Bodies and competent authorities are increasingly scrutinising the substance of MDR compliance, not just its documentation.
Sthira Assure medical device audit services provide independent assessment of quality management systems and regulatory compliance across ISO 13485, EU MDR/IVDR and FDA requirements. We work with manufacturers preparing for Notified Body audits, addressing compliance gaps identified in surveillance reviews and building quality infrastructure for new product registrations.
Key Frameworks
- ISO 13485:2016
- EU MDR 2017/745
- EU IVDR 2017/746
- FDA 21 CFR Part 820
- ISO 14971:2019
- IEC 62304 (Software)
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EU MDR Technical Documentation
EU MDR 2017/745 requires comprehensive technical documentation demonstrating conformity with General Safety and Performance Requirements. Many manufacturers still have technical files prepared under MDD standards that are inadequate for MDR review. Notified Bodies are applying significantly higher scrutiny to clinical evidence adequacy, benefit-risk determinations and post-market surveillance plans.
Clinical Evaluation Under MDR
The clinical evidence requirements under EU MDR are substantially more demanding than MDD. Equivalence claims are restricted and require extensive justification. Clinical data generated for similar devices may not be accepted without robust clinical comparison justification. Organisations must plan clinical development strategies that generate MDR-compliant clinical evidence before their legacy CE marking expires.
UDI System Implementation
Unique Device Identification obligations under EU MDR and FDA UDI requirements impose detailed labelling, database registration and traceability requirements on device manufacturers. Implementation failures, incorrect label formats, incomplete EUDAMED registration and inadequate UDI-DI management processes, are consistently identified in MDR compliance assessments.
Post-Market Surveillance Effectiveness
EU MDR post-market surveillance obligations go substantially beyond the reactive vigilance reporting required under MDD. Manufacturers must proactively collect and analyse post-market data, produce post-market clinical follow-up reports and periodic safety update reports, and demonstrate that PMS activities generate actionable conclusions that feed back into design and risk management processes.
Speak with a Medical Device Audit Specialist
Contact our team to discuss your ISO 13485, EU MDR or FDA audit requirements.