The EU regulatory landscape for medical devices can seem like a complex path dotted with curveballs along the way. New MDCG guidance, as well as the latest MDR update proposal, lead to a rapid pace of changes to background information. Our clinical team at TÜV SÜD will present a practical breakdown of the available clinical regulatory pathways, stripping each step of the clinical pathway down to its bare essentials to put each component into perspective. We will provide positive and negative real-world examples of MDR compliance, from pre-clinical data requirements to a fully established clinical evaluation, and the pitfalls of the post-market phase. And how new pathways, such as orphan and breakthrough device status, will be integrated into the current landscape of clinical evaluation routes. This session aims to provide clarity and a greater understanding of an important aspect of a medical device’s regulatory journey.
Learning Objective
- Understand the separate components of a clinical regulatory submission.
- Ability to avoid common pitfalls of the pre-market clinical phase of a medical device.
- Ability to avoid common pitfalls of the post-market clinical phase of a medical device.
Who Should Attend?
Regulatory, clinical, and quality professionals, as well as medical device manufacturers involved in MDR clinical evaluation submissions, would benefit from attending.
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
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.
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
Surash Surash
Ulrich Nitsche
