Article 15 in the MDR/IVDR uses generally defined terms but leaves some room for interpretation. Close reading of Article 15 in conjunction with other articles of the regulations can help to gain a better understanding of this role. However, this still leaves some unclear issues, for example, how an outsourced Responsible for Regulatory Compliance (PRRC), should work or what to do when things are not compliant.
Expert presenters at this workshop will lead an interactive discussion on the role of the PRRC, including where they are working with manufacturers or authorized representatives and whether they are outsourced for micro or small sized companies or in-house for larger companies. For each of these roles, scenarios will be presented with examples of challenges faced by PRRCs and how they can be handled. Scenarios will be presented based on different company situations, to explore a range of possible working methods for the PRRC to employ.
This workshop will also examine Article 15 and the connected parts of the MDR/IVDR and relevant guidance documents that may be explicitly and implicitly relevant. The potential impact of the proposed amendments to the MDR/IVDR published by the European Commission in December 2025 will also be addressed, including the latest regulatory updates. The workshop will be interactive, providing plenty of opportunity for attendees to ask questions and share their own experience.
Registration Fees & Deadlines
Learning Objectives
- What are the post-marketing considerations for IVDs in the EU?
- Do post-marketing requirements for a CDx product trigger engagement with the Pharma sponsor?
- What are some common hurdles for post-marketing considerations for IVDs?
- Understand any impacts to post-marketing considerations for IVDs due to the European Commission adaption of the proposal to simplify the IVDR – understand future implications and next steps of this proposal.
Speakers
Alex Laan
Head of IVD Notified Body, BSI Group The Netherlands B.V.
Engineer (Dipl.-Ing) in Bioprocess technology and Biochemistry. Worked as a product specialist in immunohematological products and plasma products with Sanquin blood bank, Amsterdam. QA and RA manager at IVD firm in the Netherlands. Worked for over 6 years as audit team leader, dossier reviewer and project manager at KEMA Medical Notified Body. Acted as IVD product specialist and Principal Certification Manager at DEKRA Certification, Business Line Medical (6 years). After this, worked for 4 years as a regulatory consultant, Alex now has the position of Head of the IVD Notified Body at BSI.
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.