In May 2017, Regulation 2017/746 on in-vitro diagnostic medical devices (IVDR) entered into force in Europe, with a transitional period of 5 years (date of application: 26 May 2022). This Regulation succeeds the original Directive (IVDD 98/79/EC) which was in place for over 20 years.

 

The adoption of the IVDR marks a significant development and strengthening of the existing regulatory framework for in vitro diagnostics in Europe, especially for companion diagnostics.

 

Under the IVDR, companion diagnostics will be classified as Class C devices (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. This Regulation makes the first 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 a level of uncertainty on how the regulation will be implemented. As such, guidance and clarification are required. In addition, guidance on the route for the re-certification of in vitro diagnostics already utilised to guide treatment decisions will also be required; additional information and guidance on the path for follow-on diagnostics (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, EFPIA and MedTech Europe jointly set out several key areas of uncertainty relating to companion diagnostics and the associated medicinal product in the IVDR. For each area of uncertainty, specific proposals for consideration are also laid out.