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

Gert Bos has 28 years of experience in life sciences (devices and pharma), in university, industry, 4 Notified Bodies, and in strategic regulatory and business consulting. Gert provides strategic consulting on complex regulatory matters, on interactions with Notified Bodies and EU pharma agencies, on suspensions and cancellations of certificates, field safety corrective actions and more. He is supporting due diligence processes from RA/QA perspective. And finally, he provides insightful dedicated in-house training on regulatory matters, including EU-MDR and EU-IVDR.

Lena Cordie Bancroft, Qualitas Professional Services

Lena Cordie-Bancroft is the president and principal consultant at Qualitas Professional Services, where she works with medical device, dental and IVD companies to implement ISO 13485 and FDA QS Regulation compliant quality management systems; incorporate processes to comply with FDA, EU and other international regulatory requirements related to quality systems, risk management; and regulatory compliance related to labelling and Unique Device Identification (UDI) requirements. She is a member of AAMI Sterilization Standards, ISO/TC 198 and ISO/TC 210 work groups. She is a member of ASQ, and as a member of Regulatory Affairs Professionals Society (RAPS), serves as the chairperson for the Twin Cities Chapter, is a member of the RAPS European Committee (REC), and a leader of the UK Local Networking Group.

Mindy McCann, Qserve

Mindy McCann has broad and multi-faceted experience in medical device international regulatory affairs and quality management, having worked for a start-up, a large global company, and two notified bodies, before joining Qserve, a medical device consulting company. Mindy’s enthusiasm for regulatory compliance, communication skills and leadership skills make her an effective project manager and engaging trainer. Mindy’s hands-on experience as a development engineer, notified body auditor and technical file reviewer, global certification manager, and regulatory and business executive has led to a practical approach in developing and implementing regulatory strategies and quality procedures; auditing; and writing and reviewing clinical evaluation reports, technical documentation, and clinical investigation protocols and applications. Over the past four years Mindy has been actively engaged in working closely with small and large medical device manufacturers to develop strategies, plans, training, and implementation of the EU MDR.

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