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The EU MDR/IVDR Regulatory Knowledge Hub provides in-depth analysis and practical resources focused on compliance with the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Explore expert publications covering clinical evidence, PMCF, post-market surveillance, EUDAMED, conformity assessment, Notified Body expectations, and key regulatory developments shaping the European medical technology landscape.
Proposed MDR/IVDR amendments in practice: operational implications for manufacturers
A practical examination of the proposed December 2025 MDR/IVDR amendments and their implications for lifecycle oversight and manufacturer regulatory operations Read More...
£69.00
Analysis of the European Commission’s proposal for the revision of the MDR and IVDR
A legal analysis of the European Commission proposal and its impact on certification and clinical strategy Read More...
£69.00
Clarifying the role of equivalence and similarity in medical device conformity assessment under the MDR
An authoritative explanation of equivalence and similarity under the MDR, offering practical strategies to leverage clinical data and meet conformity assessment requirements, even for high-risk devices Read More...
£50.00
How to prepare a beneficial and efficient PMS Report
A step-by-step guide to creating PMS Reports that meet regulatory expectations while delivering real business value through smarter data analysis and risk management integration Read More...
£50.00
High quality PMCF surveys under the EU MDR – from planning through to execution and data analysis
Ensure your PMCF surveys meet your regulatory needs - practical insights on planning, execution, and data analysis to stay MDR compliant Read More...
£0.00
A Notified Body’s perspectives on progress made in transitioning combination products to the MDR
Get exclusive insights from a Notified Body on the progress, challenges, and solutions for combination products transitioning to the MDR Read More...
£45.00
Post-market surveillance and risk management – a comparison of the requirements in Europe and the USA
Harmonise your regulatory approach - compare EU and US PMS and risk management requirements to streamline your strategy and avoid costly missteps Read More...
£40.00
EUDAMED: Important considerations for ensuring preparedness and compliance
Stay ahead of the curve with critical guidance on ensuring your EUDAMED compliance strategy is both effective and timely Read More...
£25.00
Planning, designing and implementing high-quality (Level 4) post-market clinical follow-up surveys
Discover expert strategies for designing high-impact Level 4 PMCF surveys to improve post-market safety and performance Read More...
£0.00
Considerations for designing and implementing successful PMCF surveys
Ensure the success of your Post-Market Clinical Follow-up surveys with proven strategies for design and implementation Read More...
£0.00
