RAPS Workshop: Mastering Notified Body Opinions for Drug-Device Combination Products under EU MDR 2017/745

The integration of notified body feedback into the regulatory pathway for combination products is a critical area. Understanding how these opinions influence product development and compliance would be insightful, particularly with the evolving EU MDR frameworks.

The workshop provides regulatory professionals with hands-on knowledge needed to obtain Notified Body Opinions (NBO) for integral drug-device combination products as specified in Article 117 of EU MDR 2017/745. The program focuses on important challenges such as regulatory classification difficulties, missing technical documentation elements and the interaction between National Competent Authorities (NCAs) and Notified Bodies. Participants will develop practical strategies for creating GSPR-compliant technical documentation and handling Notified Body questions through real-world case studies and interactive quizzes. 

This workshop will teach participants how to choose the appropriate Notified Body and streamline submission processes while shortening review periods. This session delivers a detailed plan for working with Competent Authorities and Notified Bodies including BSI, TUV, DEKRA, etc. which allows participants to learn how to handle NBO submissions for medical devices like prefilled syringes and auto-injectors.

Learning Objectives

Upon the conclusion of the program, you will be able to:

• Explain how the Notified Body (NB) opinion process impacts the regulatory submission of combination products under MDR/IVDR.
• Apply compliance and precise regulatory strategy to get a successful notified body opinion report for their integral combination product in EU.
• Create a procedure for gathering information to compile the general safety and performance requirements for combination products.

Who Should Attend?

This workshop will benefit Regulatory Professionals in Pharma and Biotech
involved in developing integral drug-device combinations (e.g., prefilled syringes, auto-injectors) under Article 117 of EU MDR.

• Device Regulatory Affairs or CMC
• Design or Quality Assurance
• Device Engineering/Development
• Human Factors Engineering
• Clinical Operations
• Device Project Management

Audience Learning Level

Intermediate: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as knowledge checks, case studies, scenario building, and polling. A high level of participation is expected from each attendee.

Agenda

Cancellations and Refunds

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. All cancellation requests must be submitted in writing to [email protected]. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email [email protected] with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected]. 

Speakers

Elisabeta Burean

Notified Body Technical Representative, TUV SUD

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Leonel Vanegas

Founder, Precision Regulatory Consulting LLC

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