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The European Regulatory Knowledge Hub delivers authoritative analysis and practical guidance on medical device and IVD regulation across Europe. Explore expert publications covering the EU MDR and IVDR, clinical evidence and PMCF, software and AI regulation, EUDAMED, sustainability and environmental compliance, and evolving European regulatory frameworks affecting market access and lifecycle compliance.
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
Regulatory Monitor – updating you on legislative changes
Get the latest international regulatory updates from the JMDR August 2026 issue – concise, expert-curated updates to keep you ahead in the medical device industry Read More...
£145.00
Sufficient clinical evidence for medical devices – What is the role of post-market real-world data?
This article explores how post-market real-world data (RWD) can support the demonstration of sufficient clinical evidence for medical devices. Read More...
£0.00
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
Navigating UDI compliance in the EU: Practical approaches for complex and special device categories
Learn actionable strategies for managing UDI for complex and special device classifications while maintaining regulatory efficiency Read More...
£50.00
The EU Data Act – how manufacturers lose control over connected device data
Prepare for the EU Data Act: explore how new data access and sharing obligations transform connected device governance and reshape manufacturers’ control of data Read More...
£40.00
Converging regulations: the EU’s WFD, SCIP reporting, the ESPR, and the future of sustainable medical device design
Navigate the intersection of safety and sustainability and uncover how converging EU environmental regulations will redefine product design and compliance strategies Read More...
£40.00
Overview of the regulatory requirements for medical devices in Switzerland
Stay compliant in Switzerland: gain a clear overview of the country’s current regulatory requirements for medical devices and how they impact market access Read More...
£35.00
A comparative analysis of the US and EU performance-based regulatory pathways with recommendations for harmonisation
Compare and align: explore US and EU performance-based regulatory pathways for medical devices and discover practical recommendations for greater global harmonisation Read More...
£45.00
The many ambiguities of the European Union’s Artificial Intelligence Act
Navigate the regulatory complexities of AI-powered medical devices with insights on the EU Artificial Intelligence Act: understand its horizontal scope and the implications for high-risk systems Read More...
£45.00
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
The future European Health Data Space Act – a wealth of possibilities and risks
The EHDS Act is coming - are you ready? Discover the regulatory implications, opportunities, and challenges that will affect the medical device industry 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
An analysis of the EU MDCG recommendations concerning the content of a Clinical Investigation Plan and an Investigator’s Brochure
Ensure your clinical investigations meet EU expectations - this expert guide clarifies what regulators expect in both the CIP and Investigator’s Brochure Read More...
£45.00
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
Regulatory requirements for medical devices and IVDs in Serbia
Unlock the key regulatory insights you need to successfully navigate the medical device and IVD landscape in Serbia Read More...
£50.00
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
