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12 docs tagged with "fundamentals"

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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.

How classification works

MDR classification rules are in Annex VIII of MDR 2017/745. IVDR classification rules are in Annex VIII of IVDR 2017/746. Classification determines the conformity assessment route, notified body involvement, and post-market obligations.

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.

Overview — Annex I (GSPR)

Both MDR 2017/745 and IVDR 2017/746. Each regulation contains its own Annex I (GSPR), with mostly parallel structure and some IVDR-specific elements.

Overview & ongoing obligations

Both MDR 2017/745 and IVDR 2017/746. Post-market obligations begin the moment a device is placed on the market and continue until the device is withdrawn from service.

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.