Training Medical Devices Regulation (MDR)

Mikrocentrum

During the Medical Devices Regulation (MDR) training, you will be guided through the new MDR regulations throughout the day.

Price

from €1,500

Level

Not specified

Kind

Training

Subject

Health and safety

More information and registration at Mikrocentrum

Description

The MDR (Medical Device Regulation) is the successor to the MDD (Medical Device Directive). The MDR outlines a renewed framework for the quality of medical devices with the aim of ensuring safety during use. Additionally, it is valuable that patients and healthcare providers can easily access adequate information about the devices thanks to the new regulations, enabling them to make well-informed decisions about their deployment and use. All existing requirements from the MDD are included in the MDR, but new requirements have also been added. Within the MDR, a distinction is made between different risk classes of medical devices. The higher the risk to the patient/client if the medical device fails, the higher the risk class of the device. The stricter the requirements imposed on this device from the MDR are for both pre-market and post-market entry. Background of the MDR Domain and definitions of the MDR Classification rules Quality management systems (QMS) Conformity Assessment Routes GSPR (General Safety and Performance Requirements) Technical documentation and requirements Clinical evidence and investigation process Post-market surveillance (PMS) Post-market clinica…