The key differences between MDR and IVDR in the EU

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THE KEY DIFFERENCES BETWEEN THE MDR AND IVDR IN
THE EU
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Overview
Comparison of the key differences between the MDR
and IVDR in the EU In Vitro Diagnostic
Regulation (IVDR) and its Key Points Medical
Device Regulation (MDR) and its Key
Points The Key Differences between In Vitro Diagn
ostic Regulation (IVDR) and Medical Device
Regulation (MDR) Conclution and References
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Comparison of the key differences between the
MDR and IVDR in the EU
In the fast-paced world of medical devices,
staying updated on regulatory changes is crucial
for manufacturers, healthcare professionals, and
patients alike. In the European Union (EU), two
significant regulations have been introduced to
enhance the safety and effectiveness of medical
devices the In Vitro Diagnostic Regulation
(IVDR) and the Medical Device Regulation (MDR).
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In Vitro Diagnostic Regulation (IVDR) and its
Key Points
The In Vitro Diagnostic Regulation (IVDR),
Regulation (EU) 2017/746, was adopted by the
European Parliament and the Council in 2017 and
came into effect on 25 May 2017. It replaced the
previous In Vitro Diagnostic Directive (IVDD)
98/79/EC and introduced a more stringent
framework for the approval and marketing of in
vitro diagnostic medical devices (IVDs). This
regulation specifically pertains to in vitro
diagnostic medical devices distributed within the
European Union.
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Key Points

1. Scope and Definition
2. Risk Classification
3. Conformity Assessment
4. Unique Device Identification (UDI)

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Medical Device Regulation (MDR) and its Key Points
The Medical Device Regulation (MDR), Regulation
(EU) 2017/745, was also adopted in 2017 and came
into force on May 26, 2021. It replaces the
Medical Device Directive (MDD) 93/42/EEC and
aims to strengthen the regulatory framework for
medical devices, ensuring a higher level of
safety and efficacy.
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Key Points

1. Scope and Definition
2. Risk Classification
3. Conformity Assessment
4. Unique Device Identification (UDI)

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The Key Differences between IVDR and MDR



TERMS
EU MDR
EU IVDR
REGULATION (EU) 2017/745
REGULATION (EU) 2017/746
REGULATION
In vitro diagnostic medical devices for human
use manufactured or sold into the European
Union.
Medical Devices for human use manufactured or
sold into the European Union
APPLICABILITY
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113 articles, focuses solely on in vitro
diagnostic devices



123 articles, applied to all human medical
devices
ARTICLES
Performance evaluation and performance studies
to justify intended patient outcome
Clinical Evaluation report based on evaluation
of clinical evidence or a clinical investigation
PRE-MARKET DATA
Class I (Low risk) Class Is (Sterile) Class Im
(Measurable) Class Ir (reusable)
Class A (Low risk) Class B (Medium)
RISK CLASSIFICATION
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Class C (Medium to High) Class D (High)
Class IIa (Low to Medium risk) Class IIb (Medium
to High risk) Class III (High risk)
RISK CLASSIFICATION
Post-Market Performance (Surveillance and
Vigilance)
POST-MARKET DATA
Post-Market Clinical Follow-Up
Applicable to all Class IIa, IIb and III devices
Applicable to all Class B, C and D devices
NOTIFIED BODIES
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Focused mainly on safety and clinical
performance in accordance to the intended
purpose of the device



Focused mainly on performance of device and
improved patient outcomes
CLINICAL EVIDENCE
Required for Class A and Class B manufacturers
updated when necessary)
POST MARKET SURVEILLANCE REPORT (PMSR)
Required for Class I manufacturers updated
when necessary)
Required for Class C and D manufacturers
updated at least annually
PERIODIC SAFETY UPDATE REPORT (PSUR)
Required for Class IIa, IIb and III
manufacturers updated at least annually
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GENERAL SAFETY AND PERFORMANCE REQUIREMENTS 23 applicable clauses as per Regulation (EU) 2017/745 20 applicable clauses as per Regulation (EU) 2017/746
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Conclusion
Navigating the regulatory landscape of medical
devices in the European Union demands a thorough
understanding of both the In Vitro Diagnostic
Regulation (IVDR) and the Medical Device
Regulation (MDR). While these regulations share
commonalities, such as risk-based classification
and conformity assessment, differences in scope,
implementation dates, and the level of notified
body involvement necessitate careful
consideration from manufacturers.
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References
REGULATION (EU) 2017/745 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on
medical devices, Regulation (EC) No
amending Directive 2001/83/EC,
178/2002 and Regulation (EC) No

• 1223/2009 and repealing Council Directives 90/385/
  EEC and 93/42/EEC
• REGULATION (EU) 2017/746 OF THE EUROPEAN
  PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on
  in
• vitro diagnostic medical devices and repealing Dir
  ective 98/79/EC and Commission Decision
  2010/227/EU

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