Key requirements for CDx product certification under the EU IVDR
The In Vitro Diagnostic Regulation (IVDR) has applied since 26 May 2022. Under the IVDR there are increased requirements for IVD companion diagnostics (CDx). Most CDx devices are now in risk Class C and require Notified Body oversight for placement on the European market. In addition, a Notified Body is required to consult the competent authority designated by the member states or the European Medicines Agency (EMA), which results in a longer approval process.
A wide range of resources to support your IVDR compliance
We understand that navigating this complex regulatory environment will be challenging for manufacturers. If you are starting your CDx IVDR journey, we have created additional resources to support you, including guidance on:
- IVDR Conformity Assessment Routes - Notified Body assessments
- IVDR Technical Documentation Submission Best Practices
- CE marking certification process for Medical devices & IVDs
Watch our webinar on CDx Updates on demand
Our webinar will equip you with the key knowledge to start your IVDR compliance journey. Sign up to listen to our experts discussing the regulatory requirements for CDx products under the IVDR, including Notified Body Conformity Assessment and consultation with EMA and provide key learnings for Technical Documentation submissions.
By signing up you will also receive regular updates on our upcoming webinars and news addressing relevant topics that may affect your business.
