The key differences between MDR and IVDR in the EU

Overview

Compa r ison of the key diff er ences between the MDR a nd

IVDR in the EU

In Vitro Diagnostic Regulation (IVDR) and its Key Points

Medical Device Regulation (MDR) and its Key Points

T he Key Diff er ences between In Vitr o Dia gnostic Regulation (IVDR) and Medical Device Regulation (MDR)

Conclution and References

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).

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.

Key Points

1.Scope and Definition

2.Risk Classification

3.Conformity Assessment

4.Unique Device Identification (UDI)

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.

Key Points

1.Scope and Definition

2.Risk Classification

3.Conformity Assessment

4.Unique Device Identification (UDI)

The Key Differences between IVDR and MDR

Medical Devices for human use manufactured or sold into the European Union In vitro diagnostic medical devices for human use manufactured or sold into the European Union.

ARTICLES

PRE-MARKET DATA

123 articles, applied to all human medical devices

RISK CLASSIFICATION

113 articles, focuses solely on in vitro diagnostic devices

Clinical Evaluation report based on evaluation of clinical evidence or a clinical investigation Performance evaluation and performance studies to justify intended patient outcome

Class I (Low risk)

Class Is (Sterile)

Class Im (Measurable)

Class Ir (reusable)

Class A (Low risk)

Class B (Medium)

RISK CLASSIFICATION Class IIa (Low to Medium risk)

IIb (Medium to High risk)

III (High risk)

C (Medium to High)

POST-MARKET DATA

Post-Market Clinical Follow-Up

Post-Market Performance (Surveillance and Vigilance)

CLINICAL EVIDENCE

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

POST MARKET

SURVEILLANCE REPORT (PMSR)

Required for Class I manufacturers – updated when necessary)

Required for Class A and Class B manufacturers –updated when necessary)

PERIODIC SAFETY UPDATE REPORT (PSUR)

Required for Class IIa, IIb and III manufacturers –updated at least annually

Required for Class C and D manufacturers –updated at least annually

GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

23 applicable clauses as per Regulation (EU) 2017/745

20 applicable clauses as per Regulation (EU) 2017/746

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.

References

REGULATION (EU) 2017/745 OF THE EUROPEAN

PARLIAMENTAND OF THE COUNCIL of 5 April 2017 on medical devices, Regulation (EC) No amending Directive 2001/83/ EC, 178/2002and 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

https://mavenprofserv.com/comparison-and-highlighting-ofthe-key-differences-between-the-mdr-and-ivdr-in-the-eu/