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Sponsored by Veeva MedTech

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

November 27, 2024
sustainable design

From design to disposal:
Reducing the footprint of single-use drug delivery devices

By Alex Fong

How can drug delivery devices manage competing priorities - reducing overall carbon footprint without expense to patient and practitioner safety or treatment efficacy. Sustainability strategies must account for commercial and budgetary pressures.

July 8, 2024
LDT Development

The FDA’s final lab developed test rule places new burdens on manufacturers

By Laura Housman

Diagnostic manufacturers and pharmaceutical sponsors with therapeutics that rely on biomarker identification or companion diagnostics should adjust their commercialization and partnership strategies to fit the new regulatory environment.

January 22, 2023
Rama Chellappa

Instilling Trust in AI

Rama Chellappa, PhD, John Hopkins University Bloomberg Distinguished Professor in electrical, computer, and biomedical engineering, and co-author of "Can We Trust AI?" looks at the promise of AI in health care and how we can best utilize this extraordinary tool to save lives and improve health equity.

October 12, 2020
Arlen Ward, System Insight Engineering

Computer Modeling and Simulation Helps MedTech Developers Bring Innovation to Reality

By Maria Fontanazza

No longer just “the big company advantage,” Arlen Ward discusses how CM&S is an accepted and viable device industry path to market for large and small medical device makers alike.

September 2, 2020
Checkbox

Cybersecurity, COVID-19 and EU MDR Hot Topics of the 2020 MedTech Summer

By MedTech Intelligence Staff

Although the full impact of COVID-19 is uncertain, one sure thing is that industry continues to crave information to help them navigate EU MDR.

June 15, 2020
Abbott FreeStyle Libre 2

FDA Clears Abbott’s Continuous Glucose Monitoring System for Use in Children

By MedTech Intelligence Staff

The FreeStyle Libre 2 now has indications for children ages four and older.

May 25, 2020
FDA

In Face of COVID-19, FDA Updates Adverse Event Reporting Guidance Document

By MedTech Intelligence Staff

The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.

March 17, 2020
N95 respiratory mask

Amidst COVID-19 Pandemic, Scams Involving Personal Protective Equipment Emerge

By MedTech Intelligence Staff

As the saying goes, if it looks too good to be true, it probably is.

View More Combination Products Articles »

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

Upcoming Events & Webinars

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On Demand Events & Webinars

February 26, 2025 – 2:00 pm – 3:00 pm
Are you talking to me? Communicating effectively with your Notified Body for an Accountable and Sustainable Working Relationship
January 21, 2025 – 11:00 am – 12:00 pm
Medical Device Labeling Best Practice for 2025: The Global Design Master
December 17, 2024 – 2:00 pm – 3:00 pm
Adapt, Thrive, and Lead: Insights for Global Medical Device Executives
October 29, 2024 – 10:00 am – 11:00 am
The Art of Benefit-Risk Calculation: Essential Tools for EU MDR Mastery

Combination Products

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