Trade Body Updates Guidance On Meeting IVDR Clinical Evidence Requirements

Fulfilling performance evaluation obligations under the EU In Vitro Diagnostics Regulation can be confusing for manufacturers and particularly SMEs. Trade body MedTech Europe explains why defining the intended purpose of a product is a good place to start.

Puzzle Piece
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Generating clinical evidence that is of a sufficient quality and quantity to satisfy requirements set out in the In Vitro Diagnostics Regulation can be tricky for manufacturers, and has led industry association MedTech Europe to recently publish a third version of its eBook on this topic.

A spokesperson for the trade body told Medtech Insight that the eBook is intended not just for companies, but also...

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