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.

When it comes to clinical evidence requirements under the EU’s Medical Device Regulation (MDR), the biggest challenge for manufacturers, irrespective of device risk class, is determining the amount of data needed to generate sufficient clinical evidence.

The challenges in obtaining the quantity of evidence required, particularly for high-risk devices, have led to certain products being taken...

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