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

Articles

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.
  • The European Medical Device Regulation
    RAPS has teamed up with Meddev Solutions to offer this MDR Guidebook in a convenient e-book format*. For anyone involved in ensuring compliance with the EU MDR, it is the ‘go-to’ reference and tool kit, intended to be your companion to reference time and time again.
  • 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 Programs

Understand the New EU Medical Device/IVD Regulations WebcastKey Challenges in Preparing for EU Medical Device Regulation (MDR)

View it on demand

The new European Medical Devices Regulation (MDR) was published in May 2017 to improve the safety and efficacy of medical devices in the EU. This regulation replaces two of the existing medical device directives by 2020. The transition window for compliance with MDR is rapidly closing, manufacturers need to be making urgent progress in addressing changed requirements and generating supporting evidence needed to for both new and existing legacy CE Marked AIMD/MDD devices. Regulatory affairs professionals with responsibility for European devices can’t afford to wait until all the supporting guidance documents and expectations are fully clarified, it is important to make assessments now to anticipate how to address new requirements while there is still enough time to generate the information, balancing how much is expected to be enough with the expense of doing too much.  

This program will be focusing 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.

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
    21-24 September 2019
    Philadelphia, PA

    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.

    WATCH NOW

Straight From the European Commission

Regulatory Focus

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