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What is a medical device?

Regulatory basis - This page is based on Article 2(1) of Regulation (EU) 2017/745 (MDR). The definition is central to determining whether your product requires MDR compliance.

What is an IVD?

Regulatory basis - This page is based on Article 2(2) of Regulation (EU) 2017/746 (IVDR). The IVD definition determines whether a product is governed by IVDR rather than MDR.

What is not a medical device?

Regulatory basis - Exclusions from the MDR are set out primarily in Article 1(5) and 1(6) of Regulation (EU) 2017/745. Equivalent IVDR exclusions appear in Article 1(4) and 1(5) of Regulation (EU) 2017/746.