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EU MDR and IVDR
Resource Center

Featured Content

May 23, 2024 |

Combination Devices: new guidance for industry and notified bodies

This European Medicines Agency (EMA) Question & Answer document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations in the context of combinations of medicinal products with medical devices.

February 13, 2024 | By MedTech Intelligence Staff

MHRA Announces New UK Approved Bodies

LNE-GMED UK has been designated as a UK Approved Body to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD).

January 24, 2024 | By MedTech Intelligence Staff

European Commission Proposes Extension for EU IVDR Compliance

If adopted, companies would have additional time—from 2027 to 2029, depending on the type of device—to gain approval under EU IVDR.

November 29, 2023 | By MedTech Intelligence Staff

Preparing for EU MDR Post Market Reporting

Karandeep Badwal, consultant and president of QRA Medical, discusses the change in focus from EU MDD to EU MDR, and how companies will need to adapt to meet new reporting requirements and maintain compliance in the European market.

October 25, 2023 | By Warren Lesack

EU MDR: Ensuring Labeling Compliance

EU MDR requires significant reforms to the device labeling process. Manufacturers must ensure that identifiers are correctly applied to products, and that key data elements and formats are accurate. In addition, manufacturers need to have access to centralized data, audit tracking, robust security controls, eSignature capabilities and strong workflow management to ensure compliance.

See more News at the EU MDR and IVDR Resource Center Archive ››

Regulatory Insights Spotlight

2022 Year-end Regulatory Benchmark Report

2022 Year-end Regulatory Benchmark Report

A new report on the state of regulatory operations in the medtech industry reveals that only 11% of respondents have a global RIM in place, even though 62% indicate a single source of truth for regulatory information is a top priority.
Download full report

Industry Insight: Modernizing Medtech Regulatory Affairs

Infographic:
State of Medtech Regulatory Affairs

Review the infographic to understand the state of global regulatory operations, year-over-year progress, and where the medtech industry is headed. Dig in deeper by downloading the full report.
View infographic

Regulatory Transformation Demands New Business Cases and KPIs: Perspectives from Cook Medical and Exact Sciences

Regulatory Transformation Demands New Business Cases and KPIs:
Perspectives from Cook Medical and Exact Sciences

Market competition and competitive pressures, particularly in Europe, are driving more medical device companies to unify regulatory data and eliminate manual processes. Cook Medical and Exact Sciences recently shared best practices for developing business cases and KPIs to support change.
Read article

Digital Transformation: Turning Medtech Compliance into a Competitive Edge

Digital Transformation:
Turning Medtech Compliance into a Competitive Edge

Hear Cook Medical, Exact Sciences, and NNIT share best practices on how companies can better support digital initiatives, turning compliance into a competitive edge.
Watch webinar

Building Medtech Resilience: Technology and Sustainable Operating Models

Building Medtech Resilience:
Technology and Sustainable Operating Models

Evolving regulations, fierce competition, and rising compliance costs have added substantial challenges and complexities to the medtech industry over the past decade. Read perspectives from Bausch Health and Medtronic on how companies can overcome obstacles.
Read article

EU MDR & IVDR Updates

  • How does IVDR transition impacts you? Deep dive into changes
  • Getting ready for the FDA’s upcoming QMSR - Top tips
  • 5 Key Priorities for Medtech Companies in 2023
  • MDR’s impact on European innovation capabilities

Featured Events

  • Veeva MedTech Summit Europe 2023, Munich
    7 - 9 November 2023
    Join Veeva MedTech Summit Europe in Munich to network, learn, and share best practices for EU MDR and IVDR with medtech peers and industry experts.

Veeva MedTech News

  • Medtech survey shows centralizing Regulatory is #1 Priority
  • 4 Lessons Learned from CDRH Officials
  • Cardinal Health Drives Proactive Quality Management for Customers Across Healthcare Continuum

Case Studies

Terumo Enables Global Collaboration and Clinical Excellence for Groundbreaking Medtech Research

Terumo Enables Global Collaboration and Clinical Excellence for Groundbreaking Medtech Research

Sponsored By Veeva Medtech

Terumo, global leader in medical technology, transforms to a unified, digital approach to manage global clinical trials and operations. Read this article to learn about the approach, processes, infrastructure changes, and impact on the business.

Read More

Supplier Quality as Competitive Advantage: Perspectives from PwC, Cardinal Health, and Veeva

Supplier Quality as Competitive Advantage: Perspectives from PwC, Cardinal Health, and Veeva

Sponsored By Veeva Medtech

To address today’s supply chain challenges and ensure quality products it’s critical to have a robust quality management system. Download this article featuring PwC and Cardinal Health for insights on building a business case and supporting digital transformation goals.

Read More

Featured Articles

May 11, 2026
Field Service Technology

The Hidden Design Flaw in Medical Device Service Technology

By Ryan Condon

Health systems globally face higher utilization, tighter scrutiny, and less operational slack. As devices become more connected and service events more consequential, the limitations of generic service technology become harder to ignore.

May 11, 2026
Cerevasc

An Endovascular Approach to Neurological Diseases Can Shift the Treatment Paradigm

By Dan Levangie

Ensuring that proven therapies can be delivered safely and accessibly to the patients who need them provides opportunity in what we innovate and in how broadly those innovations can reach.

May 11, 2026

Why Gen AI is a Win for MedTech: And, How to Unlock its Potential with the Right Policies

By Jonathan Burk

Without formal policies and governance, MedTech organizations face risks to intellectual property, product quality, and ultimately patient safety. Thoughtful AI governance enables development teams to capture efficiency gains while maintaining the rigor that the industry demands.

May 11, 2026
Data protection, intelliectual property, medtech

The Medical Device Cybersecurity Gap Hiding in Plain Sight

By Partha Anbil, Saravanan Manikandan

In healthcare, a cyber vulnerability is not just an IT problem. It can quickly become a patient-care problem.

May 10, 2026
Trust in AI

Maintaining trust in medical AI: Monitoring and managing model lifecycle

By Anna Vuolo

Healthcare environments are dynamic with patient populations, clinical practices and data collection methods continuously evolving. Similarly, effective AI systems depend on more than performance at initial deployment. They must be monitored and managed throughout their lifecycle to remain reliable, clinically relevant, and safe.

April 30, 2026

From Prototype to Production: Building a Validation Strategy That Scales with Manufacturing Volume

By Aniruddha Dhole

Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support future production increases. How does a practical framework for validation, revalidation, and process control help during medical device scale-up?

April 30, 2026

Managing AI in Medical Technology: From Innovation to Compliance

By Ali Behbahani, Dr. Ibrahim Halfaoui

Companies developing or deploying AI systems now face increasing scrutiny around risk classification, transparency and lifecycle governance. An AI management system (AIMS) aligned with ISO/IEC 42001 provides a structured way to address these challenges while significantly improving efficiency, quality, and innovation outcomes — and ensuring AI system are  effective, safe, compliant, and trustworthy.

April 30, 2026
Artificial intelligence, medical devices

Seven Things Every Medical Device Manufacturer Must Know Before Integrating AI

By Jonathan Ripley, Ruaidhrí Primrose

No longer a horizon technology, Artificial Intelligence in healthcare has reached a level of real-world performance that makes clinical value demonstrable at a critical time in healthcare – a time of clinician shortages, backlogs, and rising costs that have made access to treatment a challenge.

View More Combination Products Articles »

TOPICS

  • Digital Health
  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

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