The Impact of the EU MDR Regulation on Legacy Devices

4 – 5 December 2018
Minneapolis, Minnesota

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Under the EU approach there is no possibility of grandfathering existing products and ultimately all legacy devices (CE Marking under the current MDD) will need to meet the full requirements of the new EU MDR by 2020, with a possible three-year grace period under strict conditions.

Registering for this workshop will have hands-on case studies exercises including:

  • the impact of the changes on legacy products
  • what no "grandfathering" means more conformity assessments 
  • classification changes on legacy devices 
  • labeling changes for legacy devices – new requirements and symbols 
 

Virtual Program: Key Challenges in Preparing for EU Medical Device Regulation (MDR)

6 December 2018
11:00 – 4:15 pm EST

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Experience in-person training without the travel. This virtual  program focuses on key areas requiring significant effort to evaluate and update to maintain access to the European marking such as understanding clinical data expectations, generating clinical evaluation reports, updating technical documentation and preparing for enhanced post-market requirements.

Topics that will be covered:

  • the impact of the new clinical requirements on clinical evidence
  • new expectations of clinical evaluation reports 
  • the technical documentation required to demonstrate compliance
  • enhanced post-market expectations



Get a free chapter on Medical Device Regulations from our Fundamentals of EU Regulatory Affairs.

Publications

  • Fundamentals of EU Regulatory Affairs, 8th Edition
    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

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.

Explainers 

  • 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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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.