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