Virtual Program: Understand the New EU Medical Device and IVD Regulations

Wednesdays 3, 10, 17 and 24 May 2017
11:00 am–1:00 pm EDT

Register For Series

Register for Individual Sessions:

Week 1 – Background to New EU Regulations
Week 2 – EU MDR Requirements
Week 3 – EU IVDR Requirements
Week 4 – Technical Documentation, Postmarket and Other

Program Description

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 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.       




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

At a Glance

Date:

3, 10, 17 and 24 May 2017
11:00 am–1:00 pm EDT

Location:

Online Webcasts

Registration Fees: 

Series:
RAPS Members: $525                                       
List: $600

Register for Individual Sessions:
RAPS Members per session: $175 
List per session: $200

RAC Credits:

Entire series: 8 
Per session: 2 

Advance Registration Deadline:

Tuesday, 2 May 2017

Will this meeting be recorded?:

Yes

Objectives & Audience

Learning Objectives:

  • Understand the key final requirements of the new EU MDR and IVDR
  • Hear the interpretations of leading Notified Bodies on their expectations under the new final regulations
  • Consider the impact of the new regulations on legacy devices cleared, CE marked and under existing directives
  • Be prepared for the changes and begin to understand the impact on regulatory resources needed by manufacturers and Notified Bodies 

Who Should Attend:

  • Medical device and in vitro diagnostic regulatory affairs staff responsible for compliance, submissions, clinical and post market of products intended for Europe
  • Consultants and suppliers supporting medical device and in vitro diagnostics regulatory affairs staff 

Learning Levels: Basic, Intermediate, Advanced

Agenda

Week 1 – Background to New EU Regulations
Week 2 – EU MDR Requirements
Week 3 – EU IVDR Requirements
Week 4 – Technical Documentation, Postmarket and Other

See Full Agenda

Speakers

Bassil Akra, PhD, global director, TUEV SUED PS

Ranulf Barman, European regulatory and policy manager, Medicines and Healthcare Products Regulatory Agency

Gert Bos, PhD, FRAPS, executive director & partner, Qserve Group

Erica Conway, global head – in vitro diagnostic medical devices, BSI

Theresa Jeary, technical manager, Lloyds Register Quality Assurance

Sue Spencer, head of global medical device services, UL

Sophie Tabutin, notified body regulatory lead, BSI

Florianne Torset-Bonfillou, director of regulatory, education and quality - lead auditor, LNE/G-MED

Itoro Udofia, head of notified body, UL International (UK) Ltd. 

Notified Body Representatives


Registration Info

Series Registration Fees:
RAPS Members: $525   
List: $600

>>  Register Online For Series
>>  Registration Form (PDF) - for registration by mail or fax

Register for Individual Sessions:
RAPS Members per session: $175    
List per session: $200

Week 1 – Background to New EU Regulations
Week 2 – EU MDR Requirements
Week 3 – EU IVDR Requirements
Week 4 – Technical Documentation, Postmarket and Other

Other Information

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.

Cancellation

All cancellation requests must be submitted to raps@raps.org by 18 April 2017. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. A 20% cancellation fee will be assessed. 

Substitutions may be accepted with written approval from RAPS, and must be submitted to raps@raps.org by 18 April 2017. 

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.

NOTE: RAPS reserves the right to request additional documentation in making determinations regarding cancellations and refunds. Refunds will be granted solely at the discretion of RAPS.