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.
MDR vs IVDR — which applies?
Regulatory basis - MDR = Regulation (EU) 2017/745 | IVDR = Regulation (EU) 2017/746. Both regulations are mutually exclusive — a product is governed by one or the other, never both simultaneously.
Regulatory framework overview
Both MDR 2017/745 and IVDR 2017/746
Who needs to comply?
5 items
Who needs to comply?
MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746)
Lifecycle of a medical device
MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746)
Transitional provisions & timelines
MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746)
Glossary of key terms
MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746) — terms are drawn from official definitions in Article 2 of each regulation unless otherwise noted.