Several devices not covered by the previous Medical Device Directive (MDD) requirements now fall under the MDR requirements, and in many cases, the devices need to be re-classified.
MDR will replace the existing Medical Device Directive (92/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD).
The main reason for MDR is to ensure high standards of quality and safety for medical devices being produced in or supplied into Europe.
The regulation holds amongst other several new requirements that must be adhered to:
Reliant can offer a scalable turn-key solution and services that will support and enable startups, spinoffs, small and medium-sized medical device companies to comply with the new regulations listed above. We are ready to support the new quality and regulatory requirements that must be met throughout the medical device lifecycle.