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Flowchart on overview of requirements
Regulation 2017/746/EU on In vitro Diagnostic Medical Devices July 2017 – Draft for Approval This flowchart has been prepared by MedTech Europe as a ‘high-level overview’ of the requirements of the IVD Regulation. While MedTech Europe considers the information herein to be reliable it makes no warranty or representation as to its accuracy, completeness or correctness. This flowchart is intended for informational purpose only and should not be construed as legal advice for any particular facts or circumstances. This flowchart is intended for “internal use” by MedTech Europe members. Any “external use” of the contents of this document is subject to prior written consent of MedTech Europe. MedTech Europe reserves the right to change or amend the flowchart or any parts thereof at any time without notice. For more information please contact the regulations & industrial policy department: This presentation compares the current situation under the IVD Directive with the new requirements which will arise under the IVD Regulation. It gives an overview of the key changes without going into great detail. What to expect: Key impact on regulatory process Implementing acts Transitional Timelines
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Evidence Collection Design Manufacturer Obligations IVD
Intended Purpose Basis for Requirements Checklist Article 2(12) Annex I Section (c) What is detected / measured Define Applicable Requirements for the MANUFACTURER’s Processes Define Properties of the IVD Annex I Function Clinical Evidence Article 56 Sources of Evidence General Design and Safety requirements Annex I Section 1 Annex XIII Section 1.2 Peer Reviewed Literature Specific info to be provided Scientific Validity Annex XIII Section 1.2.1 Compile Performance Evaluation Plan (Annex XIII Section 1.1) Risk Management System Annex I Section 3 Identify Evidence Consensus / Expert opinions Self-test Analytical Performance Annex XIII Section 1.2.2 Risk Control Measures Annex I Section 4 Proof of concept studies Defines Near-patient test Intended User Determines Collects Performance Studies Clinical Performance Annex XIII Section 1.2.3 Use of Harmonized Standards / CS Article 8 Article 9 Instrument Information on scientific validity from devices measuring the same analyte Companion Diagnostic Other Evidence Published experience gained by routine testing Software Chemical Safety Annex I Section 10 Classification (Article 47, Annex VIII) Annex I Appraise data for suitability to establish safety and performance Biological Safety Annex I S. 10,11 & 12 Performance Characteristics Annex I Section 9 Manufacturer Obligations Compile Performance Evaluation Report including Clinical Evidence (Annex XIII Section 1.3) Electromagnetic Compatibility Annex I Section 17 Conformity Assessment Chemical, Physical & Biological Properties Annex I Section 10 Sufficient Evidence? YES Mechanical Safety Annex I Section 18 Article 10 Para 2 Risk Management System Infection & Microbial Contamination Annex I Section 11 NO Article 10 Para 3 Performance evaluation incl. PMPF Material of Biological Origin Annex I Section 12 Article 10 Para 4 Technical documentation Performance Studies (Annex XIII Section 2 and Section 3) Interaction with the Environment Annex I Section 13 (Clinical) Performance Study Plan Annex XIII Section 2.3.2 Article 10 Para 5 Conformity assessment, DoC and CE marking Define Applicable Requirements For the DEVICE Measuring Function Annex I Section 14 Article 10 Para 6 UDI assignment Protection Against Radiation Annex I Section 15 Article 10 Para 8 Quality Management System Study using leftover samples Study posing no risk to patients Interventional study or study posing risk to patients Software Annex I Section 16 Complete Annex XIII Procedure Complete Annex XIII & Annex XIV Procedures No notification needed Preamble 73 General Requirements Article 57 Article 58 Para 2-4, 7 General Requirements Article 57 Article 58 Article 10 Para 9,12 PMS, Vigilance Simplified Annex XIII Procedure Energy Source Annex I Section 17 Authorisation needed Article 66 To EUDAMED General Requirements Article 57 Article 58 Para 2-4, 7 Article 11 Para 1 Article 11 Para 2 If outside the EU – designate authorised rep Define a mandate for authorised rep. Mechanical and Thermal Risks Annex I Section 18 Ethical Considerations Annex XIII Sec 2.2 Considerations to Ensure Patient Safety Articles 59-76 Article 10 Para 14 To EUDAMED Registration original equipment manufacturer Devices for Self Testing and NPT Annex I Section 19 Ethical Considerations Annex XIII Sec 2.2 Complete Methodology Annex XIII Sec 2.3 Ethical Considerations Annex XIII Sec 2.2 Article 10 Para 15 Liability Information Supplied With the Device Annex I Section 20 Simplified Methodology Annex XIII Sec 2.3 Designate a Sponsor Annex XIII Sec 2.3.2 Complete Methodology Annex XIII Sec 2.3 Article 15 Person Responsible for Regulatory Compliance Machinery Directive Designate a Sponsor Annex XIII Sec 2.3.2 Designate a Sponsor Annex XIII Sec 2.3.2 Article 26,28 Registration, SRN From EUDAMED WEEE RoHS Additional Sponsor Obligations Annex XIV Article 48 If class B, C, D or A sterility – Notified Body REACH / CLP Euratom (Clinical) Performance Study Report Annex XIII Section 2.3.3 Biocides Other Legislation
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Registration Conformity Assessment Placing on the Market
Article 48 Para 10 Class A Technical Documentation Annex II & Annex III Class A Sterile Quality Management System Annex IX Presumption of Conformity Registration Economic Operators Conformity Through Harmonised Standards Article 8 Conformity through Common Specifications Article 9 SRN Registration: Manufacturer Authorised Rep. Importer Article 28 Para 1 & 2 EUDAMED Annex VI Part A Other means of conformity Article 48 Para 9 Notified Body Demonstration of Conformity Controlled Documents Demonstrating Conformity Annex II Section 4 or Annex XI Production Quality Assurance Distributor Registration Article 27 Para 2 National Database Registration Devices Device Category If no certificate exists that covers the category – NB needs to be involved before placing on the market Article 48 Para 9 Notified Body Classification Conformity Assessment Class B Classification of each device Article 47 Annex VIII Quality Management System Annex IX Article 24 Annex VI Part C Article 26 Basic UDI-DI Basis of registration Unique Device Identification Declaration of Conformity (Article 17 & Annex IV) Technical Documentation Annex VI Part A Database Requirements Article 48 Para 7, 8 Technical Documentation Annex II & Annex III Documenting conformity Includes all information on design, evidence and manufacturer’s procedures; PMS plan Article 29 Summary of Safety and Performance Article 48 Para 3, 4 Generic Device Groups If no certificate exists that covers the generic device group – NB needs to be involved before placing on the market Article 48 Para 7 Notified Body Class C Electronic System for Studies Summary of Safety & Performance Article 29 Class C & D Summary of device information Quality Management System Annex IX Article 49 Article 66 Article 69 or Electronic System for NB Certificates Notified body involvement Application for Performance Studies Type Examination & Production QMS Annex X & Annex XI Article 51 Notified body Certificates Article 73 EU Technical Documentation Assessment Certificate Performance Study Report & Summary Certificates issued by Notified Bodies Article 52 Annex IX – Class D, CoDx, Self Tests, NPTs Class D Notifications regarding Certificates Quality Management System Annex IX Notified Body Reference Laboratory Common Specifications Testing Batch Release Testing Article 48 Notified Body EU Quality Management System Certificate or Annex IX – Class B, C & D Class A sterile devices Type Examination & Production QMS Annex X & Annex XI Notified Body To EUDAMED Scrutiny Procedure Article 50 EU Type Examination Certificate If no Common Specification Annex X – Class C & D Placing on the Market Affix CE Mark (Article 18 / Annex V) Additional Conformity Requirements CoDx Notified Body Consultation with European Medicines Agency or medicines competent authority Article 48 Self Tests & NPT Technical Documentation Assessment Notified Bodies involved irrespective of class EU Production Quality Assurance Certificate Annex XI – Class C & D Class A sterile devices
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Post-Market & Vigilance
Annex XIII, Part B Post-Market Performance Follow-up Continuous Process Preamble 63 Post-Market Surveillance System for updating Technical Documentation on Post-Market Surveillance Principles of PMPF Annex XIII Section 4 Continuous process of performance evaluation Post-Market Surveillance System Article 78 PMPF Plan Analyse findings PMPF Evaluation Report PMPF Plan Annex XIII Section 5 All Classes Update over device lifecycle Post-Market Surveillance Plan Article 79 Performance Evaluation Report (Annex XIII Section 1.3) Update over device lifecycle Justification for no PMPF Annex XIII Section 8 Class A & B Post-Market Surveillance Report Article 80 Class C & D Periodic Safety Update Report Article 81 Notified Body Class D EUDAMED EUDAMED Vigilance Manuf. Incident Report Reporting & Investigating Serious Incidents Reporting Serious Incidents Article 82 Para 1 Surveillance of quality management system and devices Reporting time 15 days Article 82 Para 3 Periodic Summary Report Surveillance Assessment Periodic Reporting Article 82 Para 9 Surveillance Assessment Report & Test Report Surveillance Assessment Class C & D Annex IX Section 3 Trend Report Notified Body Trend Reporting Article 83 Assessment of Serious Incidents Article 84 Surveillance Assessment Report & Test Report Unannounced audit Class C & D Annex IX Section 3 Field Safety Corrective Action Reporting Field Safety Corrective Actions Article 82 Para 8 Notified Body Field Safety Notice Issue Field Safety Notice Article 84 Para 8 Assessment Corrective & Preventive Actions Article 84
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Economic Operators* *for Manufacturer Obligations see slide 2
Requirements for importers Importer Obligations Article 13 Para 1,2 Verify device compliance Article 13 Para 3 Add contact details to device or packaging or accompanying document Article 13 Para 4 Registration EUDAMED Article 13 Para 5 Safeguard storage and transport conditions Authorised representative Authorised Representative Obligations Article 13 Para 6 Keep register of complaints, non-conforming devices, etc. Article 11 Para 2,3 Mandate Article 13 Para 7 Reporting non-conformities and serious incidents Article 11 Para 5 Liability If modify device before placing on market Article 13 Para 8 Reporting complaints & suspected incidents Article 11 Para 6 Termination of mandate if manufacturer acts illegally: communication Article 13 Para 9 Assume the obligations of manufacturer Keep Declaration of Conformity and certificate(s) Article 12 Change of authorised representative Article 10 Para 15 Cooperation with Competent Authorities Article 15 Para 6 Modification of device Person responsible for regulatory compliance Article 22 Device traceability Article 16 Para 1 Market device under own name, change intended purpose or modify in a way which may affect compliance Article 28 Registration, SRN EUDAMED EUDAMED Article 27 Para 3 Verify registration of manufacturer or authorised rep.; add own details Within 2 weeks of placing on market Article 16 Para 2 Relabel or repackage device Authorised representative - mandate Authorised Representative Mandate - Minimum requirements Article 28 Registration, SRN EUDAMED Article 11 Para 3 Verify declaration of conformity, technical doc., conformity assessment Keep available copy of technical doc., declaration of conformity, certificates Requirements for distributors Distributor Obligations Article 14 Para 2 Verify device compliance Registration EUDAMED Requirements if relabel or repackage device Article 14 Para 3 Safeguard storage and transport conditions If modify device before making available Device information to competent authority upon request Article 16 Para 3 Add modification activity and contact details to device, packaging or accompanying document Article 14 Para 4 Reporting non-conformities and serious incidents Samples and access to device Article 14 Para 5 Reporting complaints & suspected incidents Article 16 Para 3 Field corrective actions Quality Management System Notified Body Article 14 Para 6 Cooperation with Competent Authorities Complaints and suspected incidents Article 16 Para 4 At least 28 days before market device Inform manufacturer and competent authority Article 22 Terminate mandate if manufacturer acts illegally Device traceability National Database Article 27 Para 2 Distributer Registration
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