MDR vs IVDR: Key Differences Explained

The EU replaced its old medical device rules with two separate regulations: the MDR (2017/745) for medical devices and the IVDR (2017/746) for in vitro diagnostic devices. They share common principles but differ in important ways.

What Each Regulation Covers

MDR 2017/745

Covers medical devices used on or in the body for diagnosis, treatment, monitoring, or prevention of disease. Examples: surgical instruments, infusion pumps, hip implants, patient monitors, imaging equipment, wound dressings, software that makes clinical decisions.

IVDR 2017/746

Covers devices used to examine specimens taken from the body (blood, urine, tissue) for diagnostic or monitoring purposes. Examples: blood glucose meters, pregnancy tests, COVID-19 PCR kits, laboratory analysers, companion diagnostics, blood grouping reagents.

Side-by-Side Comparison

Aspect	MDR 2017/745	IVDR 2017/746
Replaces	MDD 93/42/EEC + AIMDD 90/385/EEC	IVDD 98/79/EC
Classification system	4 classes: I, IIa, IIb, III (22 rules in Annex VIII)	4 classes: A, B, C, D (7 rules in Annex VIII)
Date of application	26 May 2021	26 May 2022
Key clinical requirement	Clinical evaluation (ongoing)	Performance evaluation + clinical evidence
Notified Body role	Required for Class IIa, IIb, III	Required for Class B, C, D
UDI requirement	Yes, phased by class	Yes, phased by class
Post-market surveillance	PMS plan + PSUR/PMCF	PMS plan + PSUR/PMPF

Why It Matters for Hospital Staff

In a hospital, you\u2019ll encounter both types of devices daily. The blood pressure cuff on the ward is MDR. The glucose test strip used by the patient is IVDR. The laboratory analyser in the pathology department is IVDR. The ventilator in ICU is MDR. Understanding which regulation applies helps you understand the regulatory requirements, the incident reporting pathway, and who is responsible for what.

Deep Dive

Our training modules cover both regulations in detail, with interactive classification exercises.

IVDR Essentials Module Device Classification Module