Leading Solutions from Global Experts for the Approaching EU MDR

When:  Nov 13, 2019 from 9:00 AM to 4:00 PM (ET)

The EU MDR significantly changes the regulatory framework for placing any new medical device on the market, but it does not provide any specific instruction for applying the new requirements to legacy devices with valid certifications under the MDD. Legacy devices can no longer be “grandfathered” into compliance and the implications are significant, from updating technical documentation, to changing product labels, and demonstrating robust clinical evidence. Manufacturers must start considering their transition plan for applying these new requirements to keep their devices in the EU market.

This workshop is aimed at the mid-level regulatory affairs professional who is responsible for applying the EU MDR requirements to his/her organization’s products. Knowledge of the MDD is not required but does help provide a better understanding the of the impact of the changes on legacy products and will enable attendees to leave the workshop with a clearer path for creating the transition plan.


Registration Closes:  6 November 2019

Refund Deadline:  14 October 2019

RAC Credits:  12 (Upon attending and completing the program)


Will the meeting be recorded?  No


Registration to 14 October 2019

MEMBER:    $1050

NONMEMBER:    $1150


Registration from 15 October to 6 November 2019

MEMBER:    $1150

NONMEMBER:    $1250

NOTE: Advance registration is required for this workshop therefore participants are encouraged to register early. Onsite registrations are not accepted.


Program Schedule


Wednesday, 13 November (9:00am–5:15pm)

  • Economic Operators 
  • Group Exercise
  • Systems and Procedure Packs
  • Labeling and IFU (GSPR 23)
  • Implant Card (Article 18)
  • UDI
  • Eudamed
  • Group Exercise

Thursday, 14 November (9:00am-5:00pm)

  • Article 88 - Trend Reporting
  • Article 117 and Drug Device Combination Products
  • Software Under MDR
  • General Update by NBs
  • Article 120(3) and Changes in the Soft Transition
  • Hazardous Materials

NOTE: The agenda may vary based on changing requirements.


Faculty (additional faculty announced at a later date)

  • Lena Cordie, president, Qualitas Professional Services, LLC
  • Keith Morel, PhD, vice president regulatory compliance, Qserve Group US, Inc.


Workshop Location

Biltmore Hotel and Suites

2151 Laurelwood Road

Santa Clara, CA 95054


Accommodation Options

Below is a list of nearby hotel properties near host venue.


Towne Place Suites by Marriott San Jose

2877 Lakeside Drive

Santa Clara, CA 95054


Embassy Suites by Hilton Santa Clara Silicon Valley

2885 Lakeside Drive

Santa Clara, CA 95054


The Plaza Suites Hotel Silicon Valley

3100 Lakeside Drive

Santa Clara, CA 95054


Cancellation

All requests for cancellation must be received in writing or by calling customer service by 14 October. Supporting documentation is required and must be received by the deadline specified. All refunds are subject to a 20% assessment unless otherwise specified.

Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email to raps@raps.org. Substitutions may be accepted with written approval from RAPS by 30 October.


Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance upon request.


Questions?

Call RAPS Solutions Center at +1 301.770.2920, Ext 200


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.


Registration Form

If it is your preference, please use the Registration Form to register by mail, email or fax. To expedite your registration for mail orders, your employer must include a copy of the completed registration form. A RAPS online account will be created to complete your purchase if you are not a member or past customer.


Program Contact

Nichelle Sankey

nsankey@raps.org

+1 301 770 2920, Ext 291

Location

2151 Laurelwood Rd
Santa Clara, CA 95054-2754