TEAM-NB To Roll Out Evidence Of Compliance With Extended MDR Period Rules 'Soon'
Questions about how manufacturers are going to demonstrate their legacy products may remain on the EU market beyond the former 24 May 2024 deadline have abounded. One vital instrument to demonstrate ongoing compliance is soon to be available.
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Finetuning The Art Of Leveraging Past Notified Body Assessments Of Technical Documentation
Recent experience gained on submitting technical documentation to notified bodies in a way that can speed up product assessments has led to a revision of guidance issued last October, as well as to work on a new paper to further streamline the notified body work related to this documentation.
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.
How And Where Tougher Clinical Evaluation Measures Under EU MDR Cause Challenges
A first of its kind study examines how large compared with medium companies are coping with the EU’s strict clinical evidence requirements. The results show how it is the more stringent demands for high-risk devices that are leading to device removals as well as market launch outside the EU.