For class III implantable devices, class IIb active devices intended to administer or remove medicinal products from the body, and Class D in vitro diagnostic medical devices, the Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) require notified bodies to consult expert panels before issuing a CE certificate.
EMA is now running a pilot that enables the expert panels to provide scientific advice for manufacturers of said high-risk medical devices. If your company is considering taking part in the pilot, please note that since 27 February 2023 manufacturers can apply via EMA’s ServiceNow portal (login required).
Please consider also that given the smaller capacity of the pilot, priority is given to manufacturers who produce the following devices:
- Orphan devices and devices for paediatric use
- Devices that help address unmet medical needs
- Novel devices that can have a major clinical or health impact.
Applications for SMEs receive special attention to ensure their representation in the pilot.
This information has kindly been provided by MedTech Europe.
