New European Medical Device and In Vitro Diagnostic Regulations


It’s time.


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. Now we want to 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. 

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.




Update

Texts for the new European Medical Device and In Vitro Diagnostic Regulations are now published.

Read the final text on Medical Devices
Read the final text on In Vitro Diagnostics


In-Person Programs

Autumn 2017

Are you ready for a new era of medical device regulations? Join the Regulatory Affairs Professionals Society (RAPS) and industry experts at one of three regional roadshows that address what MDR means for the industry.  

  • 28 November, Maidenhead, United Kingdom
  • 30 November, Hannover, Germany
  • 4 December, Ulm, Germany 

Learn from experts, network with colleagues and let RAPS 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.

inpersonprogram Medical Device Meeting—a RAPS Roadshow in Maidenhead, United Kingdom


28 November 2017 │16:00–19:30 
Abbott House
Vanwall Road, Maidenhead
Berkshire, SL6 4XE United Kingdom





inpersonprogram

Medical Device Meeting—a RAPS Roadshow in Northern Germany


30 November 2017 │14:30
Handelsverband Hannover e.V.
Room 1 (ground floor)
Hinüberstrasse 16-18
30175 Hannover





inpersonprogram

Medical Device Meeting—a RAPS Roadshow in Ulm Germany


04 December 2017 │14:30
Business Center Ulm
Magirus-Deutz-Straße 12
89077 Ulm



Webcasts

Virtual Program

virtual programUnderstand the New EU Medical Device/IVD Regulations

View it on demand

Part 1
Part 2
Part 3
Part 4

The European Commission published proposals for new regulations of medical devices and in vitro diagnostics in 2012. Now, after years of negotiation within the EU legislative system and with interested stakeholders, the new regulations are expected to be published in 2017. 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 VitroDiagnostics 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.   


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    Local & Chapter Events

    Watch this space for more upcoming EU MDR/IVD events in your area.


    calendar iconRAPS Texas Chapter

    EU In Vitro Diagnostic Device Regulation—Are You Prepared for the Changes? 

    Austin, TX       20 July

    Engage with other regulatory professionals from your local regulatory community over dinner and hear an interactive presentation on the new EU In Vitro Diagnostic Device Regulation (IVDR) in the European Union.

    The new EU IVDR will replace and repeal the existing IVD Directive 98/79/EC when it is published, currently expected during the second quarter of 2017. With the aim of tightening and strengthening the approval system for IVDs, the new regulation introduces a number of important changes. Come join us to learn how you can proactively prepare for the introduction of, and transition to, the new EU regulation once it comes into effect..

    This meeting is sponsored by the  RAPS Texas Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory and quality professionals. A light meal will be available. RAC holders can claim one  RAC recertification credit.

    Publications

    Fundamentals of EU Regulatory Affairs

    Fundamentals of EU Regulatory Affairs, Eighth Edition, will be released in December 2017 and will fully cover the new European Medical Device and In Vitro Diagnostic Regulations. © 2016 RAPS

    The EU Regulatory Affairs, Seventh Edition is currently available. © 2015 RAPS

    EU Regulatory Acronyms & Definitions

    Featuring entries selected by RAPS’ EU regulatory experts, EU Regulatory Acronyms & Definitions, Sixth Edition is a handy guide to the industry in the EU. © 2016 RAPS

    Resources

    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.
    Medical Devices Classification

    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.