Joint MedTech Europe/ EFPIA White Paper on Companion Diagnostics under the IVDR

The new In Vitro Diagnostics Regulation 2017/746 (IVDR) marks a significant development in strengthening the existing regulatory framework for in vitro diagnostics in Europe, especially for companion diagnostics.

Under the IVDR, companion diagnostics will be classified in Class C (the second highest risk level) and the corresponding conformity assessment will necessitate interaction with both a Notified Body and the European Medicines Agency / National Competent Authorities. The Regulation thus makes the first ever European regulatory link between approval of the medicine and the companion diagnostic.

While the IVDR sets out the expectations for companion diagnostics with an associated medicine, there is still uncertainty on how the Regulation will be implemented. As such, guidance and clarification are required. Additional information and guidance on the path for ‘follow-on diagnostics’ (i.e., new diagnostic tests for existing precision medicines already on the EU market that were originally approved with a companion diagnostic test) will also be essential.

In a joint white paper together with EFPIA (the pharmaceutical industry association), MedTech Europe sets out several key areas of uncertainty relating to companion diagnostics and their associated medicinal product in the IVDR. For each area of uncertainty, specific proposals for consideration are also laid out.