Last month, Medtech released the 3rd revision of the clinical evidence requirements under the EU In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR). This guidance document from Medtech is a collection of questions and answers designed to help manufacturers navigate their performance evaluation obligations under the new IVDR.
Medtech – Clinical evidence requirements under the EU In Vitro Diagnostic Medical Device Regulation – 3rd revision.
This 3rd revision of the guidance brings additional examples, improved clarity and flow, updated references and diagrams.
Many important updates have been implemented for Companion Diagnostics (CDx) such as:
- Chapter (companion diagnostics (CDx)) includes text to help manufacturers decide if their test is ‘essential’ for the safe and effective use of a corresponding medicinal product.
- New section on follow-on CDx redefines ‘follow-on CDx’ to refer to IVDR terms such as ‘equivalence’ and defines concordance and bridging studies into an IVDR context.
And a new chapter on benefit-risk determination is introduced for manufacturers that may wish to make claims for specific patient management actions (which would make the IVD more aligned with the intended purpose of a CDx).
What does this mean to you?
This guidance from Medtech on clinical evidence is relevant for all IVD manufacturers to ensure your technical documentation is aligned with Notified Body expectations. Our Technical Documentation Services experts are here to guide you in case you need assistance with your technical documentation.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.