| Theme | Innovation |
| Target Audience | Manufacturers, NB, experts panel |
| Products concerned | Innovative MD, IVD |
This MDCG guidance document provides guidance on Breakthrough Device (BtX) status under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
Main objective: to facilitate rapid market access for innovative medical devices or in vitro diagnostic devices, without compromising the requirements for clinical evidence.
This guidance covers:
- Transparency rules
- Eligibility criteria and their interpretation
- Clinical and pre-clinical assessment considerations tailored to these devices
- Post-market surveillance (PMCF/PMPF)
- The role of expert panels, notified bodies and competent national authorities
- Early dialogue and scientific advice procedures
- National and European funding mechanisms to support innovation