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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

January 20, 2026
Off-label and contraindicated medical device use

The Risk of Using a Device Off-Label Versus Contraindicated

By Attly Aycock

While off-label use may be permissible, contraindicated use still has a strong regulatory boundary as reinforced by FDA guidance finalized in 2025.

January 20, 2026
Balancing Cyber Risk

The FDA Raised the Bar on MedTech Cybersecurity: Are Companies Ready?

By Justin Kozak

In the current Cyber Threat environment, companies must have strong cyber liability insurance. Policies must specifically account for cyber-physical risks and the substantial costs of post-market remediation, including mandatory software patches and patient notifications. Insurers are well aware of the 524B mandate and are increasingly requiring proof of compliance before issuing coverage or offering favorable rates. How do you assure your cyber risk plan insurable?

January 20, 2026
ChatGPT

How ChatGPT Health is rewriting patient engagement

By Christoph Lippuner

A recent survey of 2,000 UK patients found one in four patients (24%) already use AI for health guidance, and nearly one in three (30%) would be willing to consult AI or social media rather than wait to see a clinician. Despite this growing reliance on digital tools, the same survey revealed a disconnect in patient confidence, with almost 80% reporting that they do not feel fully in control of their healthcare. How might ChatGPT Health accelerate this shift, as well as what needs to happen to ensure AI adoption genuinely empowers patients rather than adding further complexity?

January 15, 2026
Domico Med-Device in Mexico

Contract Manufacturer, Domico Med-Device, opens 23,000 sq ft Facility in Mexico

omico’s new facility expands its global production capacity and enhances its ability to be close to customers without taking on excessive risk.

January 6, 2026
Medical Device R&D Bottleneck

R&D Operations Bottlenecks in Large Life Sciences Organizations: What can MedTech Leaders Do?

By Venkatesan (Venkat) Muthukrishnan

How is software-enablement — connected devices and artificial intelligence — reshaping how products are conceived, developed, and deployed in clinical practice? Fragmented operations in large MedTech organizations are not keeping pace with the complexity of products in their pipelines.

January 6, 2026
Superemployees - AI human evolution

How is AI Enabling Darwinian growth for Life Science Professionals?

By Ivor Campbell

The initial fear that the artificial intelligence and machine learning evolution will replace humans is shifting. A new narrative recognizes the potential for an AI-enabled workforce — one where the technology is a jobs creator, enabling us all to be more productive rather than making millions of people redundant or obsolete — actually giving rise to the multi-disciplinary, power employee.

December 4, 2025

The Hidden Complexities of Medical Needle Design

By Kelly Peterson

Whether gluing or molding, designers must carefully address each challenge to ensure reliable, consistent, and accurate manufacturing – and to avoid costly redesigns or patient safety risks later.

December 4, 2025
Smart Critical Care

Using AI and LLMs to fill in fragmented data gaps within complex critical care

By Dimitar Baronov, PhD

AI and large language models (LLMs) are revolutionizing critical care by integrating scattered data from various sources to deliver real-time insights. This allows for prompt escalation or de-escalation of treatment and enhances patient outcomes. These technologies also help reduce staffing issues and prevent clinician burnout by continuously monitoring patient risk and supporting decision-making in busy ICU settings.

View More Combination Products Articles »

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

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