Event Details

With just over 6 months to go before the date of application of the EU MDR 2017/745, manufacturers need to have strategies and action plans in place to meet the requirements and challenges posed by this new regulation. This event will tackle the detailed “how to” questions manufacturers may have across many of the MDR hot topics. It will not address clinical data and evaluation, as that is very detailed and being hotly debated; This will clear the way to focus on the many other detailed issues manufacturers may have such as Economic Operators, Systems and Procedure Packs, Labeling/IFU/Implant Card, EU UDI requirements and practice, PMS and trend reporting (Art. 88), Art. 117 and drug-device combination products, Software, Hazardous Materials and Changes that can be made during the Soft Transition. Several Notified Body experts will also be on hand to give an overview of more general status and preparations (including Brexit, Eudamed, Harmonized Standards, CS, class Ir etc.) and participate with the other speakers in an open Q&A session.

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. Basic knowledge of the requirements of MDR would be beneficial, as would real-world challenges and issues posed by implementing the MDR requirements within their own organization

Agenda

Topics will include (but are not limited to):

Day 1

·        Interpreting Transition Timelines

·        No Grandfathering Means More Conformity Assessments

·        Impact on OBL Manufacturers CMR Substances

·        Classification Changes on Legacy Devices

·        Certification Renewals for Legacy Devices

·        Challenges with Notified Body Designation

Day 2

·        Labeling Changes for Legacy Devices – New Requirements and Symbols

·        Use of ISO vs EN Standards

·        Planning for Continuous PMS and PMCF 

·        CER Requirements

·        SSCP Uploads to Eudamed

·        Updating the Technical Documentation

In group activities, attendees will work with:

·        Considerations for product termination vs continuation

·        Priority setting

·        Portfolio revision

·        Budgeting resources

NOTE: The agenda may vary based on changing requirements.

Pricing/Deadlines

18 December 2020 – 10 February 2021:  $800.00 Member | $900.00 Nonmember

11 February – 03 March 2021: $900.00 Member | $1000.00 Nonmember

Speakers

Gert Bos, Executive Director, Qserve

Lena Cordie Bancroft, Qualitas Professional Services

Mindy McCann, Qserve

Cancellation Policy

All cancellation requests must be submitted in writing to raps@raps.org. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Should you need to cancel your registration, you can apply your credit to any RAPS program for the next 12 months. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org. RAPS will allow substitutions up to the first day of the event.

For any questions or concerns please contact:
raps@raps.org
+1 301 770 2920, Ext 200