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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 u2013 the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR). <br>

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The key differences between the MDR and IVDR in the EU

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

  2. Overview ComparisonofthekeydifferencesbetweentheMDRand IVDRintheEU In Vitro Diagnostic Regulation (IVDR) and its Key Points MedicalDeviceRegulation(MDR)anditsKeyPoints TheKeyDifferencesbetweenInVitroDiagnostic Regulation(IVDR)and MedicalDeviceRegulation(MDR) ConclutionandReferences

  3. Comparisonofthekey differencesbetween the MDR and IVDR in the EU In the fast-paced world of medical devices, staying updated onregulatorychangesiscrucialformanufacturers, healthcare professionals, and patients alike. In the European Union(EU),twosignificantregulationshavebeenintroduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical DeviceRegulation(MDR).

  4. InVitroDiagnosticRegulation (IVDR)andits KeyPoints 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 ScopeandDefinition RiskClassification ConformityAssessment UniqueDeviceIdentification (UDI)

  6. MedicalDeviceRegulation(MDR)anditsKey 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 ScopeandDefinition RiskClassification ConformityAssessment UniqueDeviceIdentification (UDI)

  8. The Key Differences between IVDR and MDR TERMS EUMDR EUIVDR REGULATION(EU) 2017/745 REGULATION(EU) 2017/746 REGULATION In vitro diagnostic medicaldevicesfor human use manufactured or sold into the EuropeanUnion. Medical Devices for humanusemanufactured orsoldintotheEuropean Union APPLICABILITY

  9. 113articles,focuses solely on in vitro diagnosticdevices 123articles,appliedtoall humanmedicaldevices ARTICLES Performanceevaluation and performance studies to justify intended patient outcome Clinical Evaluation report based on evaluation of clinicalevidenceoraclinical investigation PRE-MARKETDATA Class I (Low risk) ClassIs(Sterile) ClassIm(Measurable) ClassIr(reusable) ClassA(Lowrisk) ClassB(Medium) RISK CLASSIFICATION

  10. ClassC(Mediumto High) ClassD(High) ClassIIa(LowtoMediumrisk) ClassIIb(MediumtoHighrisk) ClassIII(Highrisk) RISK CLASSIFICATION Post-Market Performance (Surveillanceand Vigilance) POST-MARKET DATA Post-MarketClinicalFollow-Up ApplicabletoallClassIIa,IIb andIIIdevices ApplicabletoallClass B,CandDdevices NOTIFIEDBODIES

  11. Focusedmainlyonsafetyand clinical performance in accordance to the intended purposeofthedevice Focused mainly on performanceofdevice and improved patient outcomes CLINICALEVIDENCE RequiredforClassA and Class B manufacturers – updated when necessary) POST MARKET SURVEILLANCE REPORT(PMSR) Required for Class I manufacturers–updated whennecessary) Required for Class C andDmanufacturers– updated at least annually PERIODICSAFETY UPDATE REPORT (PSUR) RequiredforClassIIa,IIband III manufacturers – updated atleastannually

  12. 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.

  13. References REGULATION(EU)2017/745OFTHEEUROPEAN PARLIAMENTANDOFTHECOUNCILof5April2017on medical devices, Regulation(EC)No amendingDirective2001/83/EC, 178/2002andRegulation(EC)No 1223/2009andrepealingCouncilDirectives90/385/EEC and93/42/EEC REGULATION(EU)2017/746OFTHEEUROPEAN PARLIAMENTANDOFTHECOUNCILof5April2017onin vitrodiagnosticmedicaldevicesandrepealingDirective 98/79/ECandCommissionDecision2010/227/EU

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