The Medical Devices Introductory Course 2020

Regulatory Requirements

Medical Devices Directive (93/42/EEC) + AIMD + IVDD Medical Devices Regulation EU MDR 2017-745 + IVDR

The Organisation for Professionals in Regulatory Affairs

Regulatory Requirements ...any reference to ‘minimizing’ or ‘reducing’ risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety; (MDD recitals)

to enable conformity to be verified, it is desirable to have harmonized European standards to protect against the risks associated with the design, manufacture and packaging of medical devices; (MDD recitals)

The risk management system should be carefully aligned with and reflected in the clinical evaluation for the device, including the clinical risks to be addressed as part of clinical investigations, clinical evaluation and post-market clinical follow up. The risk management and clinical evaluation processes should be inter- dependent and should be regularly updated. (MDR Recitals)

In addition, in order to minimize risks or prevent incidents related to devices, manufacturers should establish a system for risk management and a system for reporting of incidents and field safety corrective actions. (MDR Recitals)

The Organisation for Professionals in Regulatory Affairs