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.


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


EU Regulatory Essentials, Medical Device and In Vitro Diagnostics: Transitioning from Current Directives to New Regulations

4 July 2017 │10:00–17:30 CET
5 July 2017 │ 09:00–12:30 CET
Brussels, Belgium

View the invitation here

This one-and-a-half-day workshop is based on the highly-regarded and consistently sold out EU workshop at RAPS Regulatory Convergence. Offered for the first time in Europe, the workshop will examine the current directives, and focus on the new EU regulatory expectations for medical devices and IVDs as introduced by the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). 

The workshop is a can’t miss opportunity to learn from experienced regulatory affairs professionals who are closely engaged with the new emerging EU regulatory requirements. They will share important insights, unique perspectives and address the challenges of the new regulations. There will be two general sessions relevant to all device/IVD manufacturers supplemented with two comprehensive tracks that delve deeper into the specifics of the new MDR and IVDR. The tracks will dig into new classification, conformity assessment, safety and performance, clinical/performance evaluation, technical documentation and postmarket requirements. 

By the end of the workshop, you will be aware of the key changes introduced by the new regulations. You also will receive expert interpretation of new expectations and be prepared to develop transition plans to navigate market access (CE Marking) expectations for both new and legacy devices being placed in Europe. If you are working in medical device/IVD regulatory affairs and quality assurance, this workshop will be invaluable. 


RAPS Regulatory Convergence: EU Regulatory Essentials, Medical Device and In Vitro Diagnostics: Transitioning from Current Directives to New Regulations

10 September 2017 │8:00 am–5:00 pm EDT
RAPS Regulatory Convergence
National Harbor at the DC Waterfront

Transition continues for medical devices and IVD from the current European Directives to new European Regulations. The Active Implantable Medical Device Directive (AIMDD) and Medical Device Directive (MDD) will merge into the new Medical Device Regulation (MDR). For the IVDs, the In Vitro Diagnostic Directive (IVDD) will be replaced by the In Vitro Diagnostic Regulation (IVDR)

This preconference workshop will divide into two tracks. Each track will reconfirm the essentials of the current directives, address the changes introduced by the regulations and provide inputs for planning a successful transition process. Experts will provide a solid understanding of what remains the same, what changes and what new requirements must be addressed.

Space is limited. Pre-registration is highly recommended.


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.


    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


    Straight From the European Commission

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