Adverse incidents of medical devices

Veracuity Blog Adverse incidents of medical devices Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746 The new European legislation places numerous new obligations on manufacturers of medical devices marketed in Europe. The current requirements for reporting adverse incidents of medical devices in Europe are detailed in the Medical Devices Directive (MDD)…

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Meeting reporting obligations for medical devices

Veracuity Blog Meeting reporting obligations for medical devices Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746 U.S. manufacturers of medical devices who are placing their devices on the European market have been facing many challenges relating to the new coming European legislation. The deadline for implementing the European Medical Devices Regulation…

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