RAPS Roadshow: Examining the New European Medical Device Regulations

Sponsored by:

Please join regulatory professionals in your region for the first Regulatory Affairs Professionals Society (RAPS) Roadshow in Europe. This event will feature RAPS’ executive director Paul Brooks, a recognized expert on medical device regulations. 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.

The new regulation will impact every medical device manufacturer’s systems, processes, resources and timelines for approvals. Transition from the current Medical Device Directive (MDD) to the new MDR is expected to begin in the summer of 2017 and to be in full force in 2020. Although three years seems to be a reasonable transition period, the challenges and practicalities of the new regulations facing manufacturers, Notified Bodies and other stakeholders are significant. There is no time to lose in preparing for and demonstrating compliance with the new regulations, to allow legacy and new devices to achieve CE marking and continued access to the European market.

This meeting is sponsored by the new RAPS Europe Regional Chapter and is hosted by SciPro. It is intended to advance knowledge and facilitate networking among regulatory professionals. SciPro will host a networking reception with light refreshments after the presentations.




  • At a Glance
  • Objectives & Audience
  • Agenda
  • Speakers
  • Registration Info
  • Cancellation

At a Glance

Date:

Thursday, 4 May 2017 (17:00–19:00 GMT)

Meeting Location:

SciPro
Seidlstraße 28
80335 München, Germany

Directions are available online.

RAC Credits:

1 RAC certification credits upon completion of the program

Registration Fees:

$40 (approx. €37.65)
Space is limited. Pre-registration is highly recommended.

Objectives

After the program, you will be able to:

  • Explain the changes from the current MDD to the new MDR
  • Describe the impact on device manufacturers and regulatory professionals
  • Evaluate how to ensure compliance in this ever-changing environment

Agenda

Thursday, 4 May 2017

16:30 –17:00Arrival and Registrations
17:00 –17:05Welcome and Intro by Paul Brooks, RAPS Executive Director
17:05 –17:50Presentation No. 1 – RAPS Overview (including Q&A), Paul Brooks, RAPS
17:50 –18:35Presentation No. 2 – Examining the New European Medical Device Regulations (including Q&A), Paul Brooks, RAPS
18:35 –18:50Presentation No. 3 – Hiring Trends in Regulatory Affairs With the Upcoming Changes in the Medical Device Industry, Christian Kalous, SciPro
18:50 –18:55Closing Statements by Paul Brooks, RAPS
18:55Networking Reception Hosted by SciPro

Speakers

Paul Brooks, executive director, RAPS

Christian Kalous, manager, SciPro

Registration Info

$40 (approx. €37.65)

Space is limited, so preregistration is highly recommended.

 

» Registration Online


» Registration Form (PDF) - for registration by mail or fax

 

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.

Program Contact

Wessel Nieuwenweg, RAPS Europe meeting planner   

Cancellation

Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200 or via email at raps@raps.org.