Fivefold Increase In MDR Notified Body Demand Could Lead EU Into Chaos
Executive Summary
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.
You may also be interested in...
First MDR Notified Body Designated In Finland As Nordic Numbers Nudge Up
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.
UK Responsible Person, EU ARs and Northern Ireland: The View From MedTech Europe
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.
EU Notified Body Association Takes Steps To Allay EC’s Virtual Audit Fears
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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: