MDR Amending Regulation Officially Published And Already In Force
The deadlines for legacy products under the Medical Device Regulation have changed. Here are the essentials that all medtech players need to understand in how the MDR has now been amended.
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There are concerns that practices by manufacturers desperate get one foot in the door at notified bodies could threaten the successful implementation of the EU Medical Device Regulation.
The revised timelines around products generally used for aesthetic purposes, a small subset of products falling under the Medical Device Regulation, create their own microsphere of complexity.
Are you uncertain whether your medtech products can benefit from transition period extensions that feature in the March 2023 amending Regulation to the MDR? The latest European Commission document offers help.