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EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck

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The new EU Medical Device Regulation (MDR) is the single largest change to medical device regulations in Europe since the 1993 introduction of CE Marking. As grandfathering of existing products is not permitted, the new regulations affect all medical devices sold throughout Europe. There is a temptation for medical device companies to think that the transition arrangements through 1Q20 under MDR leave a considerable amount of time to ensure compliance. Research predicts that companies that do not address MDR early will suffer from potential bottlenecks among Notified Bodies for certification completion and capacity shortages by compliance professionals in the preparatory process. If you have not started to plan for the transition, now is the time to act. This presentation will take you through the main regulation changes and outline key requirements affecting manufacturers moving forward.

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EU MDR Preparation: Seize the Market Opportunity and Avoid the Bottleneck

  1. 1. EU MDR Preparation OMTEC Mike Wolf CBA, CQA, RAC Chicago, IL 13 June 2018 ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 2
  2. 2. What is the new EU MDR?  Most significant regulatory change in Europe in over 20 years!  Compliance to the EU MDR required to gain and retain CE Mark  80+ delegating or implementing acts to come  Notified Bodies to be re-designated  Focus on Clinical Evidence and Post Market Clinical Follow-Up and Surveillance  Scrutiny and review of high risk devices  Improved transparency between NBs, CAs, Mfgs, and Users (UDI and EUDAMED) ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 3 The new European Union Medical Device Regulation (EU MDR) AIMD 17 Articles 35 Pages 9 Annexes MDD 20 Articles 60 Pages 12 Annexes Directives Regulation MDR 123 Articles 178 Pages 17 Annexes
  3. 3. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 4 Key Players - MDR EU National Competent Authorities Notified Bodies Reviews Testing Auditing Clinical Evaluations Records Data QMS Certificate CE Mark Medical Device Coordination Group (MDCG) Expert Panels Suppliers Importer Distributors Medical Devices with UDI Authorized Representative Manufacturer Public EUDAMED = Economic Operator PMS/PMCF Reporting = New or Changed Element MDR Person Responsible for Regulatory Compliance
  4. 4. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 5 Timelines – how long do we have? Transition Timeline 2017 [May 25] EU MDR Entered into Force 2017 [Nov 25] Notified Bodies apply for MDR Designation 2020 [May 25] Notified Bodies stop issuing MDD Certs 2017 2018 2019 2020 2024 2020 [May 26] New or Renewing Devices must have MDR certs MDD Certs Issued Existing MDD Certs Valid May 26, 2020 Date of Application May 26, 2024 Any Remaining MDD Certs Voided May 26, 2025 No further placing MDD-certified products on the market MDR Certs Issued
  5. 5. 6 Timeline Convergence – Competing Transitions ISO 13485:2016 Both ISO 13485:2003 or 2016 Certifications New ISO 13485:2003 Certifications Discouraged No 13485:2003 Certifications or Re-Certifications Allowed 01 Mar 2016 01 Mar 2017 01 Mar 2018 01 Mar 2019 MDSAP 01 Jan 2016 01 Jan 2017 01 Jan 2018 01 Jan 2019 MDSAP Audit Certified Mandatory by Health Canada EU MDR 26 May 2020 Present Day New or Renewing Devices must have MDR certificates ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc.
  6. 6. Important for orthopedic device manufacturers Revised device classification rules Extended process of conformance assessment by NB and MDCG Increased scrutiny of technical documentation - Class III and Implantable New labeling requirements Restriction of hazardous substances Risks associated with interaction between software and the IT environment within which it operates Conformance with harmonized standards  And Common Specifications yet to be published – 26 May 2020 Clinical evaluation and adequate clinical data Particular Requirements for Active Implantable Medical Devices  Devices and their component parts shall be identifiable  Shall bear a code by which the device and manufacturer can be unequivocally identified ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 7
  7. 7. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 8 Significant Change – Legacy Products CHANGE  There is no provision for grandfathering certification (CE marks) obtained under the previous Directives  All products have to be CE marked under the new Regulation 2017/745, in order to be placed on the market or put into service (MDR Article 5), after the transition period Market Access of Legacy Products IMPLICATION FOR MANUFACTURER A comprehensive plan needs to be put in place to ensure that all products that will be maintained on the EU market are CE marked in accordance with the full requirements of the new MDR. This should include products currently under development. This review may provide an opportunity for rationalization of the product portfolio and elimination of any marginal products.
  8. 8. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 9 Significant Change - Reclassification CHANGE  Certain products have received special consideration in the MDR and are subject to reclassification. (MDR Article 4)  These new provisions variously apply to cosmetic implants, standalone software, products without an intended medical purpose (MDR Annex XVI), certain spine products and reusable Class 1 devices Reclassification of Devices IMPLICATION FOR MANUFACTURER Manufacturers of medical devices should carefully examine the MDR Classification rules in Annex VIII to determine whether new conformity assessment routes are now applicable to their product portfolio. If so, they should engage their Notified Body (where necessary) and take steps to evaluate the necessary timescales involved in implementing this change. In some cases, where reclassification has occurred, this may be the first time that such relationships and agreements with Notified Bodies have been required.
  9. 9. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 10 Significant Change - Reclassification CHANGE  Changes in the classification rules of medical devices might lead to reclassification of certain medical devices  Rules organized by ‒ Non-Invasive Devices (Rules 1 – 4) ‒ Invasive Devices (Rules 5 – 8) ‒ Active Devices (Rules 9 – 13) ‒ Special Rules (Rules 14 – 22)  There is a process to handle classifications disputes ‒ Steps depend on if Manufacturer and notified body are in the same EU Member State ‒ May involve consultation with competent authority of the member state Check new classification rules Classification Change Examples • In vitro contact with cells/embryos going back into the body to be Class III (or IIa) • Apheresis devices to be Class III • IVF and ART non-invasive devices can be IIb • Spinal implants to be Class III • Total and partial joint replacements to be Class III • Devices recording diagnostic images to be IIa • Nanomaterial devices to be Class III • AIMD accessories to be Class III • Devices which are intended to be introduced into the human body via a body orifice, or applied on skin and that are absorbed by or locally dispersed in the human body are to be Class III • Reusable surgical Instruments are no longer class I
  10. 10. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 11 Significant Change – General Safety & Performance Requirements CHANGE The spirit of the “Essential Requirements” has not changed, however there are new provisions and more details required (Annex I), for example:  Hazardous substances  Devices with non-viable human cells or tissues, and other “non-viable biological substances”  IT security and prevention of unauthorized access  Risk Management  Labeling  Alignment with Global Harmonization Task Force (GHTF) IMPLICATION FOR MANUFACTURER Manufacturers need to review and update technical documentation in preparation for a complete conformity assessment against requirements of GSPR. Evidence of conformance with each GSPR should be critically assessed. Emphasis on improved risk management and risk controls will also need to be incorporated in practices and processes. Some new requirements – others just more detailed
  11. 11. Significant Change – Technical Documentation CHANGE The MDR is significantly more prescriptive about the required content of technical documentation (Technical File/Design Dossier):  Essential Requirements (ERs) are replaced by “General Safety Requirements (Annex I) and the number of requirements has been expanded  A Presumption of conformity still applies for devices that are in conformity with relevant harmonised standards (Article 8), but the Commission may define Common Specifications where no harmonized standards exist or where they are considered insufficient Additionally, there are more detailed requirements for the Quality Management Systems (QMS) (Annex IX)  EN ISO 13485:2016 was re-written and issued in 2016 with the new MDR very much in mind  It should be noted that while EN ISO 13485:2016 is not an absolute requirement there will be a general expectation that this standard will be used ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 12 Technical Documentation
  12. 12. Significant Change – Technical Documentation  Technical Documents shall include:  Device description and specification  Reference to previous and similar generations of device  Labels & IFUs  Design and Manufacturing information  Demonstration of conformance to General Safety and Performance Requirements  Benefit-Risk analysis and Risk Management  Product verification and validation  Additional Requirements for Technical Documents on Post Market Surveillance  Post Market Surveillance Plan, per Article 84  Periodic Safety Update Report, per Article 86  Post Market Surveillance Report, per Article 85 ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 13 Detailed Requirements for Technical Documents
  13. 13. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 14 Significant Change – Vigilance and PMS CHANGE  Under the new Regulation 2017/745, device manufacturers will be required to collect post-market clinical data as part of their on-going assessment of potential safety risks  Post Market Clinical Follow up (PMCF) is a continuous process with the objective of constantly updating the clinical evaluation (Annex XIV, Part B)  Additionally, reporting timeframes are tightened from 30 days to 15 days for reporting serious incidents (Article 87) Vigilance and Post Market Surveillance IMPLICATION FOR MANUFACTURER Manufacturers need to review their procedures for PMS and ensure that the responsibility for the provision of this additional data and associated support is clearly established. This is likely to require additional resources in functions that support products on the market such as Regulatory and Medical Affairs.  There will be new electronic vigilance reporting (Article 92) and Periodic Safety Update Reports (PSUR) for all devices (Article 86) subject to differing frequency and submission requirements
  14. 14. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 15 Significant Change – Vigilance and PMS Summary of safety and clinical performance  Draft is part of submission to notified body for conformity assessment  Is validated by the notified body  After validation, is uploaded to EUDAMED Two new deliverables required by the EU MDR Periodic safety update report (PSUR)  Throughout the lifetime of the device concerned, the PSUR shall set out ‒ Conclusions of the benefit-risk determination ‒ Main findings of the PMCF ‒ Volume of sales of the device and estimated evaluation of the size and other characteristics of the population using device, and where practicable, the usage frequency
  15. 15. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 16 Significant Change – Clinical Evaluations CHANGE  The MDR is more specific about the need for clinical evidence and clinical evaluation, proportionate with the risk associated with a given device (Annex XIV, Part A)  Reliance on the scientific literature to demonstrate equivalence will be more tightly regulated, and clinical evaluations will be more closely aligned with clinical trials associated with medicinal products Clinical Evidence and Clinical Evaluations IMPLICATION FOR MANUFACTURER This may require manufacturers to obtain additional clinical data from clinical studies. There will be additional scrutiny of Clinical Evaluation Reports (CERs) by Notified Bodies as outlined by new guidance (MEDDEV 2.7.1 rev. 4). CERs that previously were of a suitable level and standard and accepted by Notified Bodies, may no longer be accepted. Manufacturers should plan to review all of their CERs if not reviewed within the last 1-2 years and ensure that CERs include Post Market Surveillance data; especially where devices are new to market and where clinical data was limited at the time of first CE Marking.
  16. 16. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 17 Significant Change – Labeling CHANGE Requirements for product labeling are more prescriptive  For example, information supplied by the manufacturer shall be made available and kept up to date on the manufacturer’s website (Chapter III, 23.1) IMPLICATION FOR MANUFACTURER Manufacturers should carefully review the adequacy of their product labelling and precautionary statements and consider how this will be reflected on their websites. There are requirements for  Specific details for labels and for sterile packages (Annex I).  Inclusion of information on residual risks for vulnerable patient groups (e.g. children, pregnant or nursing women) and, if applicable, on appropriate precautionary measures in the instructions for use.  Hazardous Substances All EU labeling and IFU’s likely to be impacted
  17. 17. 18 Significant Change - EUDAMED What is EUDAMED? ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. • SU  EUDAMED is a central European databank that will be accessible to notified bodies, economic operators, sponsors, and to the public to the extent specified  It will include protections for personal data  What’s driving EUDAMED?  Article 14a (MDD 93/42/EEC)  Clinical investigations  Vigilance and incident reporting  Status of conformity on issued certificates  Registration of manufacturers and EUAR
  18. 18. Technical Docs to MDR Certification Timeline ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 19 Many factors impact the timeline for transition of existing product submissions MDCG Consultation for Class III & Implantable Devices Only Technical Documentation Updates for MDR likely to include: • Design Requirements traced to new Safety and Performance Requirements • Risk Management File/Report • Clinical Evaluation Plan/Report • Gaps in Clinical Evidence • Any equivalence to competitive device data replaced with company’s own data • Post Market Surveillance Reporting • PMS/PMCF Plan/Report, PSUR/SSCP Reports (when needed + translations) • Labeling +UDI + Authorized Rep/Branding Changes + Translations • Declaration of Conformity + UDI inspections in place at DCs Technical Documentation Update (? weeks) Notified Body Notification & Planning (? weeks) First evaluation by Notified Body (40 days) Response (15 days) Second evaluation (20 days) MDCG (21 days) Scrutiny (60 days) Certification decision (15 days) Submission required for: • First time products • Change to products
  19. 19. What factors will slow down the process? Delays in Notified Bodies receiving their designation to MDR Notified Body capacity constraints Additional scrutiny of Notified Body performance Additional scrutiny of technical documentation by Notified Bodies Extended process of conformity assessment  Especially for Class III and implantable devices Insufficient evidence of compliance with GSPR – remediation and delay Inadequate clinical data -- remediation and delay Natural tendency of manufacturers to wait until last moment ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 20 Increased scrutiny, NB capacity, insufficient evidence from manufacturers
  20. 20. Significant Change – Notified Body Scrutiny Articles 35-50 detail the significant changes to Notified Bodies, their designation and continuous assessment The process of designation of a Notified Body is complex and may take a long time  All Notified Bodies are going through this process over ~18 months  Notified Bodies could apply for designation beginning in November, 2017 Critical review of Notified Bodies assessments of technical documentation and clinical evaluation documentation  Translates into pain for industry in CER and technical documentation review activities Existing Notified Body structure will undergo a major change, expecting many Notified Bodies impacted resulting in a potential significant reduction in available Notified Bodies ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 21
  21. 21. 22 Notified Body & Talent Capacity  Now only 59 Notified Bodies – reduced from 83 prior to MDR publication  Reducing number with Increased workload  Unannounced inspections o Manufacturers o Critical suppliers  Greater scrutiny in general (e.g. Clinical Evaluations)  NBOG codes granted to Notified Bodies with MDR designation uncertain • Will likely affect the scope of some Notified Bodies  Notified Bodies competing with Manufacturers and Consultants for qualified people  EN ISO 13485:2016 and MDSAP are competing for NB time and resources  Some NBs cancelling contracts  Some NBs not taking on new work Status and availability of Notified Bodies is uncertain ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc.
  22. 22. Significant Change – The Role of EUAR CHANGE  There are also more prescriptive requirements placed on EU Authorized Representatives (EUAR) (Article 11)  The MDR states that “the authorised representative should be jointly and severally liable with the importer and the manufacturer“  The EUAR will also be required to be registered and must also have a PRRC  The MDR extends the scope of the regulation beyond the device manufacturer to other Economic Operators in the supply chain  Distributors and Importers are now specifically regulated (Article 25) and have specific regulatory obligations too ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 23 EU Authorized Representative IMPLICATION FOR MANUFACTURER Manufacturers should consider their entire Supply Chain to ensure that these provisions are adequately addressed and agreed with their business partners. In addition, they should identify a person who is suitably qualified to assume the PRRC role. Agreements with EUARs, if used, should be revisited and updated together ensuring that EUARs have defined plans to be registered and also have appropriate levels of insurance to cover their new liability.
  23. 23. What about Brexit? ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 24 Still so many unknowns – difficult to forecast outcomes UK policy makers and industry have indicated support for convergence with EU device regulatory framework i.e. MDR While the UK remains part of the EU (during transition period) the MDR will be implemented Post Brexit, UK regulatory framework will be required ABHI (UK Trade Association) is working closely with MHRA and policy makers to ensure harmonization is achieved with EU and rest of global markets Still unclear regarding roles and responsibilities and impact to UK stakeholders – some UK Notified Bodies are making plans to relocate Headquarters to EU High % of total CE markings are issued by Notified Bodies based in UK  Even higher % of CE markings for Class III devices Majority of European Authorized Representatives are based in UK After Brexit, they will no longer be in Europe
  24. 24. 25 What should we do to implement MDR? Some advice….. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. Rule 8 Engage Senior Management internally • Overall plan for timeline and resources  Review all of your devices against revised classification rules • Existing products and those under development • Identify path to CE Mark for any devices with new classification  Open a dialogue with your Notified Body • Understand their intentions relative to designation as NB for MDR • Confirm your interpretation of device classification • Discuss scheduling considerations • Agree on path forward and tentative schedule  Discuss with your current European Authorized Representative • Confirm their plans in light of new requirements • Identify potential alternates  Decide timeline for ISO 13485:2016 readiness  Identify Person Responsible for Regulatory Compliance (PRRC)
  25. 25. 26 What should we do to implement MDR? Some advice….. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. Rule 8 Revise Technical File for each product family • Annex I – General Safety and Performance Requirements • Create new checklist to replace “Essential Requirements Checklist”  Revise and upgrade each Clinical Evaluation Report (CER) • Complete and comprehensive – Start early! • Critically examine the clinical data you have, and its adequacy • Get help from internal and/or external SMEs  Enhance Post Market Surveillance processes • PMCF and PSUR  Review labelling against expanded requirements • Annex I Chapter III • UDI  Determine status of devices with regard to Restricted Substances • If above threshold, decide alternate materials or strong risk/benefit rationale
  26. 26. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 27 Review your product portfolio for possible rationalization Additional Recommended Activities Rule 8 Perform a portfolio review to determine what products will remain in the European Market or require CE Mark for country market use  Develop exit plan for existing CE Marked devices where re-certification will not be pursued – complete product EOL prior to certification expiration date  Review all remaining devices against revised classification rules • Review existing products and those under development, current MDD classification vs. new MDR Classification • Identify path to CE Mark for any devices with new classification
  27. 27. Finding business advantage in MDR Compliance pioneers can be perceived as having superior systems  “They’ve cracked it.” Gain market share when laggards get trapped in bottleneck and fail Product portfolio rationalization simplifies product support, reduces cost  Accelerate end-of-life for marginal products Strengthening technical documentation improves knowledge and confidence  GSPR evidence  Clinical evidence Process of achieving MDR compliance will build new knowledge among key staff  Internal study and “figuring it out”  Transfer of knowledge from external resources See Maetrics whitepaper “Market Opportunity Value of MDR” ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 28 Go early, exploit distance from slow adopters, maximize & leverage new knowledge
  28. 28. In Summary Conformance with the MDR is a significant business challenge that must be overcome in order to enjoy continued access to the EU market To meet this challenge, manufacturers must be proactive and begin preparing now Engage immediately with Notified Body regarding intentions and timeline Manufacturers must closely follow the emerging regulatory landscape, keeping alert for the detailed Implementing and Delegating Acts that are required in order to make the MDR operational The availability of resources, both internal and external, are likely to prove crucial to effective implementation Success will likely require strengthening of technical evidence documents  GSPR and CER Executive support and proactive program management of MDR implementation is a prerequisite for a manufacturer’s success. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 29
  29. 29. Questions & Close ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 30
  30. 30. BACKUP SLIDES 31 ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc.
  31. 31. ©2018 Maetrics. All Rights Reserved. ® Trademark of Theoris Group, Inc. 3 How Can Maetrics Help You? Our firm delivers compliance strategies that enable our clients to achieve new efficiencies and adjust to compliance standards successfully across the life sciences industries’ product life cycle: REGULATORY COMPLIANCE  Global regulatory strategies (FDA/EU/Other)  Compliance audits & gap analyses  Mock inspections  FDA warning letter responses & remediation  Facilities operations review  CE Mark REGULATORY AFFAIRS  US Class III medical device submissions; EU Class III MDD submissions (change amendments, design dossiers)  Independent regulatory guidance to product development teams  Technical file remediation  EU MDR / MDSAP / ISO 13485:2016 Compliance QUALITY MANAGEMENT SYSTEMS  Quality systems auditing  Pre-certification auditing  ISO certification readiness  Batch records documentation  Master record & technical file remediation  CAPA/NCR services  Auditing, internal & external  Complaint handling & recalls PERFORMANCE IMPROVEMENT  Kaizen event planning  Mfg process improvement  Operations/asset utilization (Mfg, Inventory, DC & Transportation)  Value Stream mapping & process standardization & simplification PRODUCT LIFE CYCLE MANAGEMENT  Product risk management framework & risk assessment  Risk controls to drive results in acceptance, mitigation, and avoidance  Design verification & activities M&A INTEGRATION & DEAL SUPPORT  Due diligence  Regulatory compliance  Quality Remediation & Operational Integration  Product Transfers  Facility Consolidation DATA ANALYTICS & REPORTING  Performance analytics (Vision Tool)  Risk mitigation & compliance awareness Clinical & Development Manufacturing Distribution Sales & Marketing CLINICAL EVALUATION REPORTS (CERS)  CERs strategies & guidance against Annex X MEDDEV 2.7/1 Rev. 4  Data/literature protocol & search  Full product CERs or updates to CERs post review (medical writing)  Internal CER process improvement P&PC / VALIDATION  Validation master plan  Process & product validation  Computer systems validation  Equipment validation  Special processes & procedures  Test method validation  Packaging  Sterilization TRAINING  Portfolio of specialized courses in regulatory, quality, risk management, sterilization and contamination control MEDICAL DEVICES and DIAGNOSTICS ORGANIZATIONAL CHANGE MGMT  Due diligence  Regulatory compliance  Quality & Operational Integration INFORMATION TECHNOLOGY  Strategy & policy  510(k) device software development and testing  Data migration validation Note: This represents the highest volume of service offerings, but does not represent our entire service capability

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