This session will provide practical guidance for companies developing companion diagnostics (CDx) for the EU market under the IVDR. We’ll explore how and when to engage with Notified Bodies—starting from early planning through to IVDR technical documentation submissions. Key considerations for companion diagnostic devices will be discussed, including regulatory expectations, documentation requirements, and common hurdles encountered during Notified Body review and EMA Consultation. Attendees will gain insights into how to proactively manage Notified Body interactions and avoid delays in the certification process.
Registration Fees & Deadlines
Member: $0 | Nonmember: $25
Learning Objectives
- Understand how and when diagnostic companies should engage with NBs when developing a companion diagnostic for the EU market
- Learn what type of information is typically needed from the pharmaceutical companies who sponsor CDx development to support the IVDR submission
- Know when the NB should be involved throughout the development of a companion diagnostic
- Understand the key considerations for submitting companion diagnostics (Class C medical devices) for CE marking to a notified body
- Understand how and when the NB interacts with the EMA during the drug submission process
- Understand the NB perspectives on common hurdles for CDx CE marking applications
- Send questions ahead of the event to Kathie.goodwin@lilly.com for discussion during the Q&A
Speakers
Elizabeth Linch
Senior Technical Specialist and Scheme Manager - IVD, BSI (The British Standards Institute) Group
Elizabeth Linch is a Senior Technical Specialist and Scheme Manager at BSI Group, performing conformity assessments of in vitro diagnostic (IVD) devices with a particular focus on companion diagnostics (CDx) under the EU In Vitro Diagnostic Regulation (IVDR). With more than a decade of experience spanning industry and notified body certification, she has conducted numerous EMA consultations and CE marking assessments under the IVDR. Before transitioning into the notified body business, Elizabeth contributed to the design and development of next-generation sequencing assays, including Oncomine™ Oncology panels, and supported large-scale genomics initiatives such as the Saudi Human Genome Program and the U.S. Million Veterans Program. Elizabeth brings a unique dual perspective from both the development and regulatory arenas, enabling her to evaluate innovative diagnostics with scientific rigor while supporting their pathway to compliance. She is committed to advancing regulatory science and fostering innovation in precision medicine.
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.
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
support@raps.org.