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. 

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

inpersonprogram


RAPS Roadshow: Examining the New European Medical Device Regulations


4 May 2017 │17:00–19:00 GMT
München, Germany

Sponsored by:

SciPro-logo

Join regulatory professionals in your region for the first Regulatory Affairs Professionals Society (RAPS) Roadshow in Europe. This half-day event will feature RAPS’ executive director Paul Brooks, a recognized expert on medical device regulation. His presentation will address the key changes introduced by the new European Medical Device Regulation (MDR) including the expanded scope of the regulation, and changes in classification and conformity assessment. Brooks also will discuss RAPS’ current initiatives and commitment to serving the European regulatory community.

Space is limited. Pre-registration is highly recommended. 


inpersonprogram


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

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. 



inpersonprogram


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 ET
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, so preregistration is highly recommended.



Webcasts

Virtual Program

virtual programUnderstand the New EU Medical Device/IVD Regulations
Watch it live:
Wednesdays 3, 10, 17 and 24 May 2017
11:00 am–1:00 pm EDT
Or view on demand

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.    


Thank You To Our Sponsors

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Local & Chapter Events

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

calendar iconRAPS New York/New Jersey Chapter:

European Changes Affecting IVD Manufacturers—Going from Directive to Regulation 
Flanders, NJ     16 March

The new European medical device regulations (MDR) and in vitro diagnostic regulations (IVDR) will come into force in May 2017, with full implementation deadlines now set for May 2020 and May 2022, respectively. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

This presentation will cover the major changes in the regulatory framework and ways in which device manufacturers are developing plans to meet these changes and to determine the impact on their business.

Join others from your local regulatory community to explore these changes and discuss what it means for manufacturers, regulatory professionals and how you will comply in this ever-changing environment.

This event is sponsored by the RAPS NJ/NY Chapter and is intended to facilitate networking among area regulatory personnel. Pizza and soda will be available for all attendees. RAC holders may claim two RAC recertification credits.  



calendar iconRAPS Wisconsin Chapter:

The EU Medical Device Regulation (MDR): Ten Steps to Certification 
Wauwatosa, WI       26 April

Join regulatory colleagues from your region for an evening of networking and an expert presentation on the EU Medical Device Regulation.

Medical device manufacturers are facing major changes in the EU regulatory framework that oversees market access to Europe. This presentation will provide an overview of the draft MDR, including highlights of the Notified Bodies designation process, expected transition timelines and chapters and annexes of the regulation. You’ll come away with 10 key steps to successful certification.

This meeting is sponsored by the RAPS Wisconsin 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.