mdi Europa has set up a checklist that is based on a formal template issued by the German competent authority. The template is used when reviewing the Technical Documentation, more… Read More
Tag: Clinical Evaluation
Updated Clinical Evaluation Guidance on Comparability
In an effort to bring its guidance documents on clinical evaluation up to date, the International Medical Device Regulators Forum (IMDRF) has asked for feedback on proposed revisions to three… Read More
Why is a Clinical Evaluation so Important?
Both, the Medical Devices Directive 93/42/EEC (MDD) and Regulation (EU) 2017/745 on Medical Devices (MDR) require manufacturers of medical devices to draw up a clinical evaluation for their devices. The overall aim… Read More