The key differences between the MDR and IVDR in the EU

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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1. THE KEY DIFFERENCES BETWEEN THE MDR AND IVDR IN THE EU WWW.MAVENPROFSERV.COM

2. Overview C o m p a r i s o n o f t h e k e y d i ff e r e n c e s b e t w ee n t h e M D R a n d IVDR in the EU In Vitro Diagnostic Regulation (IVDR) and its Key Points Medical Device Regulation (MDR) and its Key Points T h e K e y D i ff e r e n c e s b e t w ee n I n V i t r o D i a g n o s t i c Regulation (IVDR) and Medical Device Regulation (MDR) Conclution and References

3. 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).

4. 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.

5. Key Points Scope and Definition Risk Classification Conformity Assessment U n i q u e D e v i c e I d e n t i f i c a t i o n (UDI)

6. 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.

7. Key Points Scope and Definition Risk Classification Conformity Assessment U n i q u e D e v i c e I d e n t i f i c a t i o n (UDI)

8. The Key Differences between IVDR and MDR T E R M S E U M D R E U I V D R REGULATION REGULATION (EU) 2017/745 REGULATION (EU) 2017/746 APPLICABILITY 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.

9. A R T I C L E S 123 articles, applied to all human medical devices 11 3 a r t i c l e s , f o c u s e s solely on in vitro diagnostic devices PRE-MARKET DATA Clinical Evaluation report based on evaluation of clinical evidence or a clinical investigation Performance evaluation and performance studies to justify intended patient outcome RISK C L A SS I F I C A T I O N Class I (Low risk) Class Is (Sterile) Class Im (Measurable) Class Ir (reusable) Class A (Low risk) Class B (Medium)

10. RISK C L A SS I F I C A T I O N Class IIa (Low to Medium risk) Class IIb (Medium to High risk) Class III (High risk) Class C (Medium to High) Class D (High) P O S T - M A R K E T DATA Post-Market Clinical Follow-Up Post-Market Performance (Surveillance and Vigilance) NOTIFIED BODIES Applicable to all Class IIa, IIb and III devices Applicable to all Class B, C and D devices

11. 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

12. GENERAL SAFETY AND PERFORMANCE REQUIREMENTS 23 applicable clauses as per Regulation (EU) 2017/745 20 applicable clauses as per Regulation (EU) 2017/746

13. 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.

14. References R E G U L A T I O N ( E U ) 2 1 7 / 7 4 5 O F T H E E U R O P E A N P A R L I A M E N T A N D O F T H E C O U N C I L o f 5 A p r i l 2 1 7 o n medical devices, R e g u l a t i o n ( E C ) N o a m e n d i n g D i r e c t i v e 2 00 1 / 8 3 / E C , 1 7 8 / 2 00 2 a n d R e g u l a t i o n ( E C ) N o 1 22 3 / 2 00 9 a n d r e p e a l i n g C o un c i l D i r e c t i v e s 9 / 3 8 5 / EE C and 93/42/EEC R E G U L A T I O N ( E U ) 2 1 7 / 7 4 6 O F T H E E U R O P E A N PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in v i t r o d i a g n o s t i c m e d i c a l d e v i c e s a n d r e p e a l i n g D i r e c t i v e 98/79/EC and Commission Decision 2010/227/EU

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