The EU-MDR amending regulation (EU) 2023/607, allows Manufacturers to place MDD CE marked devices on the European market up to December 2027 and 2028, if a set of conditions ensuring the safety and effectiveness of said devices are met.
To benefit from this extension, Manufacturers must demonstrate compliance to the EU-MDR QMS requirements and prove they have lodged an application with a Notified Body by May 2024.
This presentation will provide a review of the amending regulation (EU) 2023/607 and quickly move into the latest updates and lessons learnt on the EU-MDR post May 2026 and the RAPS Euro Convergence.
A live Q&A portion with the speaker will follow the presentation.
This event is brought to you by the RAPS San Francisco Chapter to encourage knowledge sharing and community development.
Registration Fees & Deadlines
Member $10 | Nonmember $25 | Students $5
Learning Objectives
- Update on the latest progress on the EU-MDR extension post May 2024
- Share best strategies to move forward for the different compliance scenarios
Who Should Attend?
Regulatory Affairs, R&D, Engineering, Quality, Marketing & Sales personnel
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.
Speakers
Hasnaa Fatehi, PhD is a certified MedTech regulatory affairs and quality assurance professional with
over 12 years' in industry and unmatched work experience across Europe, Asia and North America.
Hasnaa runs a boutique consultancy business where she helps MedTech company leaders bring safe and
effective devices to Europe, the Middle East and Asia Pacific with the CE Mark, while decreasing their
overall compliance cost and time to market.
Hasnaa chaired the TOPRA MedTech SPIN committee from January 2021 to May 2023 and is the current
RAPS Western Canada Chapter Leader. She is an avid proponent of EDI&B in the Regulatory profession
and a "re-imaginer" of the function as a whole.
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 support@raps.org. 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 support@raps.org 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
RAPS@raps.org