Fivefold Increase In MDR Notified Body Demand Could Lead EU Into Chaos
Latest EU survey predicts unprecedented hike in demand for notified body assessments between 2021 and 2024 and insufficient notified body capacity under the Medical Device Regulation.
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The latest update in the Medical Device Regulation page of the European Commission's Nando database represents the 18th listing under the new regulation. Numbers are rising slowly.
The UK responsible person is the UK equivalent of the Authorized Representative in the EU. MedTech Europe’s Jesús Rueda gives an update on the early experiences of medtech manufacturers seeking to comply with the UK’s new standalone regulations.
The European Commission has reluctantly allowed virtual audits in the context of new MDR and IVDR. The EU notified body association is helping the collective effort to meet its strict requirements.