GETTING READY FOR THE EUROPEAN UNION (EU) MEDICAL DEVICE REGULATION (MDR)

Transcription

1 GETTING READY FOR THE EUROPEAN UNION (EU) MEDICAL DEVICE REGULATION (MDR) Caroline Leab Abbott Director of Regulatory Affairs David Wolf PTC Program Director of Medical Device Strategy liveworx.com

2 NEW EU MDR AGENDA MDR BACKGROUND MDR TRANSITION TIMELINE MDR SCOPE AND IMPACT EU UDI OVERVIEW KEY TAKEAWAYS First Major Revision to the EU Regulatory System in over 20 Years. 2

3 MDR BACKGROUND 3

4 WHAT IS THE NEW MDR? THE NEW EUROPEAN MEDICAL DEVICE REGULATION Active Implantable/Medical Device Directives (AIMDD and MDD) are being replaced by a new Medical Device Regulation (MDR). A PERFECT STORM: 3 year transition period MDD 20 articles MDR 123 articles 80+ delegating or implementing acts to come 58 remaining Notified Bodies to be redesignated MDSAP Global Auditing 60 pages 175 pages New Quality Systems standard (ISO 13485:2016) 12 annexes Directive 17 annexes Regulation Focus on Clinical Evidence, Post Market Clinical Follow-Up & Post Market Surveillance Scrutiny and review of high risk devices Improved transparency between NBs, CAs, Economic Operators, & Users UDI and EUDAMED 4

5 BACKGROUND AND HISTORY 2012 [Feb-09] Commission Action Plan for immediate actions 2013 [Sep-24] Recommendation on audits and assessments performed by NBs 2008 [May-08] Public Consultation on Recast of MDD 2013 [Apr-05] Recommendation common framework for UDI 2016 [Jun-27] Consolidated text of proposed Regulation [May] PIP manufacturer implants banned 2013 [Sep-24] Regulation on designation and supervision of NBs 2016 [Jul-26] Revised Blue Guide 2012 [Sep-26] Proposal for regulation on medical devices 2017 [May 25] Publication of MDR with 3 year transition 5

6 KEY GOALS OF THE MDR The Commission action plan of 2012 introduced many new requirements/proposed elements. The new regulation addresses many of these: 6

7 MDR TRANSITION TIMELINE 7

8 MDR TRANSITION TIMELINE (EOJ MAY 5, 2017; FULL MDR COMPLIANCE BY MAY 25, 2020) No Grandfathering May 25, 2020 every EU submission reviewed as if a new product under the new Regulation! 8

9 MDR SCOPE AND IMPACT 9

10 OVERALL INDUSTRY IMPACTS EU HAS ALREADY SEEN ~20% REDUCTION IN THE NUMBER OF NOTIFIED BODIES; MORE CLOSURES EXPECTED OTHER NBS WILL BE LIMITING SCOPE (E.G. NO ACTIVE IMPLANTABLE, NO COMBO DEVICES, NO TISSUE, ETC.) EXIT OF NBS MEANS EXISTING COMPANIES MUST FIND NEW NBS, PUTTING ADDITIONAL DEMANDS ON ALREADY LIMITED RESOURCES EVERY ECONOMIC OPERATOR MUST BE RE- DESIGNATED UNDER THE MDR EU MDR SUBMISSIONS WILL LOOK CLOSER TO FDA PMA SUBMISSIONS Include process validation in the technical documentation Class III and Implantable devices go through MDCG Consultation and Scrutiny additional Clinical Evidence generation expected pre- and post-market SIGNIFICANT RESOURCE BURDEN TO UPDATE THE QMS, RE-REGISTER SITES AND QUALITY SYSTEMS, AND BRING LEGACY PRODUCTS INTO ALIGNMENT WITH NEW REQUIREMENTS NO TECHNICAL FILE GRANDFATHERING Insufficient Clinical Evidence for claims, no cert under MDR Heavy product rationalization in the EU expected from industry 10

11 KEY CHANGES MDD/AIMDD TO MDR DEVICE CLASSIFICATION CHANGES INCREASED CLINICAL EVIDENCE AND CLINICAL EVALUATION REQUIREMENTS FOR ALL DEVICE CLAIMS No longer able to leverage similar device data to make equivalence arguments unless the mfr has open access to the associated DHF and Post Market Surveillance data Planned, Proactive Post Market Clinical Follow- Up expected (not just passive complaints monitoring) INCREASED SCRUTINY OF TECHNICAL DOCUMENTATION (CLASS III AND ANY CLASS IMPLANTABLE) ECONOMIC OPERATORS Liability, OBL, Distributors, Importers, Manufacturers, etc. COMMON SPECIFICATIONS UNIQUE DEVICE IDENTIFICATION (UDI) AND INFORMATION TO THE USER AND PATIENT GENERAL SAFETY & PERFORMANCE REQUIREMENTS (REPLACE ESSENTIAL REQUIREMENTS) PMS, VIGILANCE, SURVEILLANCE NEW ROLE OF RESPONSIBLE PERSON Additional to the Quality System Management Rep and EU Authorized Rep 11

12 KEY ELEMENTS OF A MDR-COMPLIANT PMS SYSTEM Inputs FCSA & CAPA Vigilance Complaint Trends Clinical Registries/ Studies Publications Significant Changes Post-Market Surveillance System (SOPs & Infrastructure) Product-Specific Post-Market Surveillance (PMS) & Post-Market Clinical Follow-Up (PMCF) Plans EUDAMED EU Database (UDIs) Risk Management File Update Post-market Clinical Follow-up Report (PMCF-R) Clinical Evaluation Plan/Report Update Class III, IIb, or Implantable Devices Annual or Triggered Update Class IIa, Class I Every 2 years or Triggered Update IFU/Patient Brochure/Promo Material Alignment with RM/CER Updates T PMS Trend Report Periodic Safety Update Report (PSUR) Summary of Safety & Clinical Performance (SSCP) T Class I devices NB/CA Accessible: Class IIa, IIb, III and Implantable devices PUBLIC INFO: Class III and Implantable devices 12

13 EU UDI AGENDA EUDAMED EU UDI Database 1. EU UDI Overview 2. EU UDI Process 3. Responsibilities 4. US vs. EU UDI Differences 5. Implementation Timelines 6. Summary 13

14 EU MDR/IVDR UDI OVERVIEW 14

15 7. Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 27 and with the registration obligations referred to in Articles 29 and The quality management system shall cover all parts and elements of a manufacturer's organization dealing with the quality of processes, procedures and devices. (h) Verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29; Article 10 General Obligations of Manufacturers UDI: Idenitifcation and Traceability of Devices

16 EU UDI RELEASE PROCESS 16

17 Step 1 Obtain a Single Registration Number (SRN) Step 6 Release the Medical Device for Market Sales Step 2 Obtain a UDI from an Assigning Entity Step 5 - Registration of Medical Devices in EUDAMED Step 3 Obtain the certificate from the notified body Step 4 Register in the Electronic UDI Database Process to Release Devices for Sale in the EU Market

18 RESPONSIBILITIES 18

19 Manufacturer The person who manufacturers or has a device designed, manufactured and markets that device under his name Is responsible for UDI assignment and the European Unique Device Identification Database (EUDAMED) Distributor A distributor/importer assumes the obligations of a manufacturer If he markets a device under his name Except when an agreement states the manufacturer is identified (on label) and is responsible Reprocessor A person who reprocesses a Single-Use Device (SUD) is considered the re-manufacturer of the SUD Assumes the traceability obligations Manufacturers, Authorized Representatives or Importers Responsible parties must ensure the UDI DI is in the Registration System It must be Complete, Correct and Updated by the Relevant Party

20 RESPONSIBILITIES 20

21 GHTF + IMDRF Global Harmonization Task Force and International Medical Device Regulators Forum US and EU UDI largely based on these guidance's Responsibility Responsible Party Differences US Labeler vs EU Manufacturer Labels and Packages Automatic Identification and Data Capture and Human Readable Interpretation UDI assigned and marked with AIDC+HRI on device labels and packages Standardized Date Format UDI Format Changes US date format (YYYY-MM-DD) EU not Required Global Issuing Agencies UDI Issuing Agencies GS1, HIBCC and ICCBBA Software Label and Software UDI Harmonization EU label and software UDI must be identical Similarities Differences

22 IMPLEMENTATION TIMELINES 22

23 UDI Date of Application Registration of Devices Info Relating to the Device MDR three years after entry into force (May 25, 2020) IVDR five years after entry into force (May 25, 2022) Due the later of the date of application or 6 months after publication of notice in Article 34(3) Before releasing a device, system or procedure pack for sale assign a basic UDI-DI, provide it to the UDI database together with other core date referred to in Part B of Annex VI Article 29(4) shall apply 18 months later (November 25, 2021/2023) before placing the device on the market and keep it updated Basic UDI-DI Type, number and expiry date of the certificates Member State in which the device is placed on the market Member States where the device is to be made available for class IIa, class IIb or class III devices Risk class of the device Reprocessed single-use device (y/n) Presence of a substance considered to be a medicinal product If product is derived from human blood or human plasma Presence of tissues or cells of human or animal origin Number of Clinical Investigations Annex XVI products require intended purpose other than medical Contact Information Class III implantable devices require summary of safety and clinical performance Device Registration - Implementation Timelines

24 UDI Carrier Must be places on the label of the device and on all of the higher levels For Implantable and Class II devices/class D IVDs 1 year after the date of publication (May 25, 2021/2023 For Class IIa and Class IIb devices/class B and C IVDs 3 years after the date of application (May /2025) For Class I devices/class A IVDs 5 Years after the date of application (May 25, 2025/2027) Reusable Devices Require UDI Carrier on the Device itself 2 Years after the applicable class compliance date Labels and Packages - Implementation Timelines

25 EU UDI SUMMARY 1. The transition from directives to regulation introduces changes to UDI 2. EU UDI is intended to improve traceability of medical devices, incident reporting, provide more targeted field safety corrective actions and better monitoring by competent authorities 3. Before a device is placed on the market The core data elements must be submitted to the UDI database The devices and its device packages must have UDI s in the UDI Carrier (AIDC (barcode) and HRI) 25

26 EU MDR KEY TAKEAWAYS 26

27 EU MDR KEY TAKEAWAYS FOR MEDICAL DEVICES 2017: - Quality System & Data Management System/Infrastructure gap assessments - SOP/template updates: Piggy back ISO 13485:2016 initiatives as much as possible - Create Checklists for Product-level Gap Assessments and Technical File Updates - Establish MDR Health Metrics by product understand cost of compliance - Product Rationalization 2018: - QS Infrastructure programs underway - Product-specific gap assessments underway using checklists, highlight risks/mitigations needed - Begin staffing permanent and contract headcount: - CEP/CERs, Risk Management/Sustaining Engineering, PSUR/SSCP annual reports, UDI, Labeling updates, Design Requirement updates and related testing (e.g. biocompatibility, common specs, etc.) - PMCF and Retrospective clinical evidence generation work to fill clinical evidence gaps for product claims - Phase 1 Audits start for MDR QMS Certifications 27

28 2019: EU MDR KEY TAKEAWAYS FOR MEDICAL DEVICES - Full scale implementation of the MDR prior to May 25, All product development, renewal, and significant product/manufacturing change programs need to be executing against MDR Safety & Performance, Clinical Evaluation, Labeling, Technical Documentation requirements in order to achieve MDR certifications in 2020 onward 2020: - No Turning Back All MDR Compliance! - Maintenance only for MDD/AIMDD Certified Products until cert expiration or significant change occurs 28

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