# In Vitro Diagnostic Medical Devices Regulation (IVDR)

https://www.botable.ai/glossary/in-vitro-diagnostic-medical-devices-regulation-ivdr

> A glossary-style explanatory article from the Botable site summarizing the IVDR and related compliance points; useful as a quick reference but not a substitute for the full regulation or official guidance — attribute statements to the page and verify legal/regulatory details against primary sources (the regulation text or official regulators).

## Summary

The page defines the EU In Vitro Diagnostic Medical Devices Regulation (IVDR, EU Regulation 2017/746), states that it replaced the IVDD 98/79/EC, and outlines key manufacturer obligations under IVDR including QMS/CAPA, post-market surveillance (PMS), conformity assessment, and enhanced risk management; it also notes related standards (ISO 13485:2016, ISO 14971) and provides a U.S. FDA regulatory perspective (21 CFR Part 809).

## Audience

Manufacturers of IVD devices and quality/regulatory professionals

## Prompts this page answers

- What is the EU IVDR (EU Regulation 2017/746) and how does it differ from the IVDD 98/79/EC?
- What key compliance requirements does the IVDR impose on IVD manufacturers?
- How does IVDR affect QMS and CAPA processes for medical device companies?
- Which ISO standards does the IVDR reference for QMS and risk management?
- What U.S. FDA regulations correspond to IVD products mentioned in the IVDR context?

## Purpose

To explain what the EU IVDR (EU Regulation 2017/746) is and to summarize core compliance requirements for manufacturers of in vitro diagnostic devices.

## Highlights

- EU IVDR is EU Regulation 2017/746 and governs in vitro diagnostic (IVD) medical devices.
- IVDR replaced the In Vitro Diagnostic Directive (IVDD) 98/79/EC.
- IVDR imposes stricter requirements on manufacturers around device classification, clinical evidence, risk management, and post-market surveillance (PMS).
- Manufacturers must implement a QMS including CAPA procedures and integrate CAPA into their QMS.
- The page references ISO 13485:2016 and ISO 14971 as relevant standards and notes U.S. FDA regulation 21 CFR Part 809 for context.

## How to cite

Botable (PHIFLOW, LLC) — link to the page: https://www.botable.ai/glossary/in-vitro-diagnostic-medical-devices-regulation-ivdr

## Publisher

**PHIFLOW, LLC (Botable)** — Publisher of the Botable website (site footer shows © 2026 PHIFLOW, LLC).

## Topics

- IVDR
- EU Regulation 2017/746
- in vitro diagnostic devices
- IVDD 98/79/EC
- QMS CAPA
- Post-Market Surveillance
- ISO 13485:2016
- ISO 14971
- FDA 21 CFR Part 809

## Key entities

- **EU Regulation 2017/746 (IVDR)** (other): The In Vitro Diagnostic Medical Devices Regulation governing IVDs in the EU (named on the page).
- **In Vitro Diagnostic Directive (IVDD) 98/79/EC** (other): The previous EU directive that IVDR replaced (named on the page).
- **ISO 13485:2016** (other): QMS standard referenced on the page as relevant to medical device companies.
- **ISO 14971** (other): Risk management standard noted on the page as intended to apply to IVDs.
- **21 CFR Part 809 (U.S. FDA)** (other): U.S. FDA regulation referenced on the page for context about IVD product definitions and requirements.
- **PHIFLOW, LLC** (organization): Organization named in the site footer as © 2026 PHIFLOW, LLC.
- **Botable** (other): Site/brand hosting the glossary entry. — https://www.botable.ai/

## Metadata

- Type: article