IVDR: New Regulations for IVD and Companion Diagnostics (CDx)

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The European "In Vitro Diagnostic Medical Devices Regulation" (IVDR, Regulation (EU) 2017/746) will come into force on 26 May 2022. Amendments to the federal Medical Devices Law Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG) will take effect at the same time. These amendments will regulate and supplement the implementation of the IVDR in Germany and enact changes to many legal requirements and practical framework conditions for placing in vitro diagnostic medical devices (IVD) on the market, approval and implementation of performance studies with such devices, and product use risk assessments. The Paul-Ehrlich-Institut (PEI) and the Federal Institute for Drugs and Medical Devices (BfArM) jointly invite interested parties to a dialogue in which information on the changes will be presented.

New legal requirements

Risk classes are a new concept being introduced in the IVD field. In addition, notified bodies will be involved in significantly more conformity assessment procedures than in the past. Companion diagnostics (CDx) are being defined for the first time and are now subject to additional regulatory requirements within their risk class. CDx are used to select a population of patients optimally suited for treatment with a specific drug in terms of safety and/or efficacy. Regulatory requirements for CDx lead to close cooperation between drug and IVD development.

The regulation envisages revised requirements for the approval of IVD performance studies and new notification procedures. In the future, applications for the approval of a performance study must be submitted sequentially: first to the responsible ethics committee and then afterwards to the responsible higher federal authority. There are changes to the reporting obligations for serious adverse events (SAEs). The division of responsibilities between the PEI and the BfArM are also newly regulated at the national level.

Target Audience

The target audience is primarily manufacturers of IVD and pharmaceutical manufacturers, but also other interested parties, e.g. the Ethics Committee, notified bodies, and other authorities.

Opportunity for questions

During the event, there will be room for questions from the participants. You can also send us your questions on the topics to covered at the event in advance. Questions can be sent as part of the registration process via the corresponding field in the registration form.

We ask for your understanding that not all questions asked in advance can be addressed during the event due to time constraints. Any remaining questions will be answered post-dialogue.

The event will take place online via WebEx.

The lecture language is german.

Topics and Speakers

• Legal background: IVDR and national implementation
  Ortwin Schulte, Dr Jana Knauer, BMG
  
• Legal background: CDx in the IVDR and the Medical Devices Law Implementation Act (MPDG)
  Dr Ekkehard Stößlein, BfArM
  
• Co-development of CDx and medicinal products (German only)
  Dr Jörg Engelbergs, Dr Hilke Zander, Paul-Ehrlich-Institut
  
• Clinical biomarker-based drug trials
  Dr Ilona Reischl, HMA CTFG, subgroup IVD-CDx
  
• Performance studies – ethics commission
  RAin Julia Rümler, Association of Medical Ethics Committees
  
• Performance studies – procedures with authorities
  Dr Ulf Schriever, BfArM
  
• Performance studies – submitting applications in DMIDS
  Dr Sandra Veldhoen, BfArM
  
• Companion diagnostics under the IVDR: the role of notified bodies in the companion diagnostics conformity assessment procedure
  Dr Rolf Thermann, TÜV Rheinland, head of the “IVD Notified Body Working Group on CDx within the framework of the “EMA CDx Consultation WG”