MDR/IVDR Fundamentals
What are MDR & IVDR?
MDR (EU 2017/745)
Medical Devices Regulation - governs all medical devices from simple bandages to complex implants.
Applied: May 26, 2021
IVDR (EU 2017/746)
In Vitro Diagnostic Regulation - governs devices that test blood, urine, tissue samples.
Applied: May 26, 2022
Why New Regulations?
- Enhanced Patient Safety:
Stronger checks before and after devices reach patients
- Improved Transparency:
More information available to healthcare professionals
- Better Traceability:
Track devices from manufacturer to patient
Key Changes from Old Directives
Understanding what's different under the new regulations
| Area | Old System | New Regulations |
|---|---|---|
| Scope | Medical/IVD devices only | Includes software, genetic tests, aesthetic devices |
| Classification | Simpler rules | Stricter, more risk-based classification |
| Clinical Evidence | Less demanding | More data required, ongoing follow-up |
| Surveillance | Reactive reporting | Proactive, systematic monitoring |
Current Transition Periods (2025)
Extended deadlines to prevent device shortages
Essential Regulatory Definitions
Key terms and definitions from MDR and IVDR regulations that healthcare professionals need to understand
Medical Device (MDR Article 2)
Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following medical purposes:
- • Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
- • Diagnosis, monitoring, treatment, alleviation or compensation for an injury or disability
- • Investigation, replacement, modification or support of anatomy or physiological/pathological processes
- • Supporting or sustaining life
- • Control of conception
- • Disinfection or sterilization of medical devices
Examples: Stethoscopes, surgical instruments, pacemakers, wheelchairs, diagnostic software, hospital beds, defibrillators
In Vitro Diagnostic Medical Device (IVDR Article 2)
Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body.
Primary purposes include:
- • Information concerning physiological or pathological state
- • Information concerning congenital physical or mental impairments
- • Information concerning predisposition to medical conditions or diseases
- • Information to determine safety and compatibility with potential recipients
- • Information concerning therapeutic response or reactions
- • Defining or monitoring therapeutic measures
Examples: Blood glucose test strips, pregnancy tests, COVID-19 rapid tests, laboratory analyzers, blood typing kits