New European Medical Device and In Vitro Diagnostic Regulations

The European Commission is ushering in a new era of medical device and in vitro diagnostic regulations. What do they mean for industry? Are you ready?

Only RAPS brings together the leading industry experts, regulators and Notified Bodies who have been tracking the evolution of the MDR and IVDR from the beginning. We will connect you with the world’s largest community of regulatory professionals to fully understand the texts and hash out the challenges of tracking and implementing the new requirements. RAPS is here to help you prepare for the changes and understand the impact on your organization’s regulatory resources.
 

Join our next MDR workshop in Brussels for expert interpretation of new expectations. Be prepared to develop your own transition plans to navigate market access (CE Marking) expectations for both new and legacy devices being placed in Europe.

 2018-date-icons-140x140-2-(1).jpgTransitioning to the new EU MDR and IVDR: A Workshop on Real World Implementation Experiences 

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New EU Medical Device and IVD Regulations Explainer

This interactive presentation with RAPS Executive Director Paul Brooks explores the changes in EU medical device and IVD regulations, and how regulatory will be impacted. Start familiarizing yourself with the new rules and plan how to transition your organization’s products into compliance before the new regulations come into force.

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Publications

A lot has changed in the EU regulatory landscape; get the new, updated ultimate reference guide. This edition of Fundamentals of EU Regulatory Affairs focuses on changes to healthcare product development, manufacturing and marketing across the EU.

Fundamentals of EU Medical Device Regulations (e-book)

Fundamentals of EU Medical Device Regulations is designed for regulatory professionals working in the EU market at all levels. Whether you’re new to the profession or a veteran, you’ll find valuable information in the carefully curated pages.

Global Medical Device Regulatory Strategy
As globalization continues to increase, more companies are marketing products in multiple countries and regions. This book provides a “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices.

EU Regulatory Acronyms & Definitions, Sixth Edition
Featuring entries selected by RAPS’ EU regulatory experts, EU Regulatory Acronyms & Definitions, Sixth Edition is a handy guide to the industry in the EU. No matter your area of expertise—biologics, medicinal products, medical devices and more—RAPS helps regulatory professionals translate EU regulatory language into an invaluable reference guide.
 

Virtual Program

Understand the New EU Medical Device/IVD Regulations Webcast Understand the New EU Medical Device/IVD Regulations

View it on demand

Part 1 | Part 2 | Part 3 | Part 4

This four-week virtual program draws together industry experts and leading Notified Bodies who have been closely following the evolution of the proposed regulations, anticipating the final texts, developing positions on what will be required by the regulations, and understanding the impact on manufacturers, devices and systems both new and legacy.

Uniquely, each week provides different perspectives/opinions from different Notified Bodies and experts on the key significant changes that will impact all medical devices and in vitro diagnostics being placed into Europe under the new European Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). This program will also consider the impact on legacy devices cleared, CE marked, and under the existing EU Medical Device Directive (MDD) and In Vitro Diagnostics Directive (IVDD).

From the convenience of your own viewing location, this cost-effective resource is one you can watch live with your colleagues. Recordings of the sessions will also be available with your registration.
 

Online Courses

Medical Devices: EU Regulations

Regulation of IVDs for Key International Markets

Intermediate Medical Writing: Medical Devices

Regulatory Affairs Certificate: Medical Devices
 

Events:

RAPS Regulatory Convergence
1-4 October 2018
Vancouver, BC

See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

Quick Links

Straight From the European Commission

Medical Devices Classification

Learn how ‘general’ medical devices are categorized into classes according to the degree of risk inherent in the device.

RAPS Europage

Join the RAPS Europage for national regulatory news from across Europe—from and for regulatory professionals.

Regulatory Focus

Get timely, quality regulatory news, information and analysis straight from the only dedicated to covering regulatory issues associated with healthcare products and the regulatory profession.