8 Steps towards EU-MDR implementation
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1 8 Steps towards EU-MDR implementation Gert Bos Executive director & Partner A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright Qserve Group B.V.
2 Key steps towards EU-MDR/IVDR compliance 1. Scope and Plan 2. GAP assessment 3. Portfolio assessment 4. Global Impact assessment 5. Master compliance roadmap 6. Regulatory Training 7. Implementation 8. Effectiveness check EU-MDR compliance Page 2 Copyright Qserve Group B.V.
3 1 - Scope and Plan Understand environment, sense of urgency A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright Qserve Group B.V.
4 Objectives in legislative reform Consistently high level of health & safety protection for EU citizens Sufficient clinical data Free and fair trade of medical devices throughout the EU = Clinical Evidence Adaption to significant technological & scientific progress in the sector over last 2 decades. Page 4 Copyright Qserve Group B.V. State of the art
5 Changes to Notified Bodies Expected 50% not re-designated or with significant scope change! Regulation on NB designation & recommendation on NB work Notified Body number dropped from 87 to 56 expectations for next 6-12 months: more to go Some remain with reduced scope Notified bodies under pressure and scared Ongoing initial reviews stifle on growing requirements on clinical data and limits to equivalence use Line-extension reviews getting cumbersome Renewal halted; certificates not renewed in time Certificates suspended without clear warning NBs careful in accepting transfers Waiting lists generally increasing Page 5 Copyright Qserve Group B.V. MHRA
6 Transition details and timelines *From DoA of MDR, NO significant changes and PMS, Vigilance EO requirements of MDR to be met Yr 0 Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Yr 9 Entry into force Transition period Date of Application, (DoA) MDD certificate [Art. 120(2)*] MDD certificate [Art. 120(2)*] MDD certificate UDI wave Soft transition UDI implementation UDI wave MDD certificate shortened [Art. 120(2)*] Making available on the market [Art. 120(4)] UDI wave NB designation under MDR MDR certificate [Art. 120(5)] renewal Page 6 Copyright Qserve Group B.V. Clinical study [Art. 120(11] Studies may continue; AE-reporting in accordance with MDR
7 Transition details and timelines MDR Transition period Yr 0 Year 1 Year 2 Year 3 Year 4 Year 5 Soft transition Year 6 Year 7 Year 8 Yr 9 Entry into force Date of Application, (DoA) Key period to come into compliance for all products that will be MDR certified and for those that will be produced in soft transition phase Page 7 Copyright Qserve Group B.V Soft transition under MDD certificate for products that do not require changes in design and in key suppliers / subcontractors Sell out of stock of products produced under MDD before the date of application
8 Transition details and timelines Transition period Yr 0 Year 1 Year 2 Year 3 Year 4 Year 5 Soft transition Year 6 Year 7 Year 8 Yr 9 Entry into force Date of Application, (DoA) Short phased clinical trials for Wave 1 PMS, PMCF PMCF plans & actions Upgrade CER to rev 4 and then to rev 5 Page 8 Copyright Qserve Group B.V Define State of Art Continue clinical trials for late MDR transfers (Wave 2) Sell out of stock of products produced under MDD before the date of application
9 Scope and Plan Steering Committee GAP Implement time-critical elements Program Management Taskforces, BUs Verification Finetuning Improvement Implement full plan Page 9 Copyright Qserve Group B.V.
10 2 - GAP assessment High level review A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright Qserve Group B.V.
11 Impact assessment high level vs. detailed Key dossiers first Page 11 Copyright Qserve Group B.V.
12 Impact assessment Clinical details separate if necessary Page 12 Copyright Qserve Group B.V.
13 Impact assessment QMS elements next Page 13 Copyright Qserve Group B.V.
14 Draft high level rationales early Rationales on classifications Rationales to exclude clinical study requirement Rationales on equivalence based on own product line Rationales on use of historic data Rationales on exemption lists Page 14 Copyright Qserve Group B.V.
15 GAP assessment Dossiers QMS 2017 GAP Implement time-critical elements Core team Verification Finetuning Improvement Implement full plan Page 15 Copyright Qserve Group B.V.
16 3 - Portfolio assessment Rationalisation and choice of focus A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright Qserve Group B.V.
17 Focus and portfolio rationalisation Where are the gaps? Sufficient clinical data for each indication? Strong supply chain management, withstanding UAV? Access to all technical data? What is key in my pipeline? Which products are already nominated to be replaced? Which development projects absorb most resources? Where will new opportunities arise? For which products are we a strong player? Page 17 Copyright Qserve Group B.V.
18 Portfolio analysis Still covered by definition? Change in class? Enough historic (clinical) data? Costs for rewrite upgrade new data conformity assessment? Dependence on CE in RoW market? ROI feasible? Page 18 Copyright Qserve Group B.V.
19 Portfolio Assessment visualisation helps! Product A Product B Product C Product D Product E Product F Clinical evidence Limited data No data No data Data available Data available No data PMCF Unstructured data Limited data Limited data Limited data Data available No data Transparency and traceability New systems to be implemented (e.g. UDI, Summary of safety and clinical performance, Implant card) Economic operators Contracts, responsibilities, liabilites, information flow in complaint handling and vigilance to be reworked QMS Massive overhaul of processes and procedures in conjunction with ISO 13485:2016 system Reclassification Reconfirmation with NB Stay as they are upclassiffications Scrutiny No scrutiniy expected Some products Not expected Notified Body NB1 NB2 NB3 NB4 Page 19 Copyright Qserve Group B.V.
20 Portfolio Assessment simplification Clinical evidence PMCF Transparency and traceability Economic operators WAVE 1 Collect clinical data PMCF and focussed study PHASE OUT 2024 PHASE OUT 2024 WAVE 2 WAVE 1 STOP 2020 Limited data No data No data Limited data Data available No data No money spending No money spending Top up clinical data fixable Limited data Limited data Limited data Data available Top up consultation Early start Top up consultation New systems to be implemented (e.g. UDI, Summary of safety and clinical performance, Implant card) Contracts, responsibilities, liabilites, information flow in complaint handling and vigilance to be reworked No data QMS Reclassification Scrutiny / Consultation Notified Body Reconfirmation with NB NB 1 No scrutiniy expected Massive overhaul of processes and procedures in conjunction with ISO 13485:2016 system Integral QMS system - PDCA life-cycle management Some products Stay as they are Shift NB Additional consultation NB 4 NB1 NB2 NB3 NB4 IIa, III or drug Additional review time Page 20 Copyright Qserve Group B.V.
21 Portfolio assessment Dossiers QMS Portfolio assessment 2017 GAP Implement time-critical elements Core team Verification Finetuning Improvement Implement full plan Page 21 Copyright Qserve Group B.V.
22 4 - Global Impact assessment Balance EU versus RoW regulatory status and market share A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright Qserve Group B.V.
23 Global impact of rationalisation Many countries rely on existing certificates in their market approval Repurposing of data is complicated in case of differences Changes in EU might lead to change notice elsewhere Page 23 Copyright Qserve Group B.V.
24 Repurposing of data Complicated in case of differences in e.g. Claims Intended use Clinical equivalence base Design dossier elements will differ in substantial elements: STED summary Risk management Labeling, IFU Marketing wording Etc. Page 24 Copyright Qserve Group B.V.
25 Changes in EU might lead to change notice elsewhere Initially in MDR compliance jump MDR application MDD and MDR in parallel Confusion during transition period and soft transitioning Timeline for reporting change outside EU: MDD => MDR Continuously, as EU-MDR moves to continuous improvement Annual and faster updates CE certificate forseen RoW registration slow to follow as not yet on improvement spiral Page 25 Copyright Qserve Group B.V.
26 Inclusion of RoW impact in portfolio assessment Includes RoW registrations as input to rationalization decisions Dossiers QMS Portfolio assessment GAP 2017 Core team Implement time-critical elements Verification Finetuning Improvement Implement full plan Page 26 Copyright Qserve Group B.V.
27 5 - Master compliance roadmap Strategic planning and commitment A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright Qserve Group B.V.
28 Stakeholders, structure, dependencies Contributors to extended core-team Corporate lead versus business unit independency Coordination and Cooperation Central versus local training and communication Page 28 Copyright Qserve Group B.V.
29 Time critical elements Clinical data generation if gap is big Clinical studies if no own data for high risk devices and implants PMCF data in general Stimulation of literature generation on low risk products Supply chain changes that have significant impact New suppliers of key ingredients New subcontractors of critical sub-assemblies / devices Transition away from existing OBL structures Shift in Notified Body where needed Full portfolio, or selected product lines Page 29 Copyright Qserve Group B.V.
30 Link to concurrent changes ISO 13485:2016 MDSAP ASEAN Eurasian Union Compliance improvement systems Corporate programms Timelines might be different Focus and drive might be challenging to combine Alignment requires corporate / top management sponsorship Page 30 Copyright Qserve Group B.V.
31 Early debate with Notified Bodies Resources Readiness and timelines; new sampling mechanisms Discussions on rationales Discussions on portfolio rationalization Discussions on transfer from other NBs Page 31 Copyright Qserve Group B.V.
32 Master compliance roadmap Dossiers QMS Portfolio assessment GAP Verification Finetuning Improvement 2017 Core team Implement time-critical elements Implement full plan Clinical Supply chain Notified Bodies QMS dossiers Page 32 Copyright Qserve Group B.V.
33 Master compliance roadmap Dossiers QMS Portfolio assessment GAP Verification Finetuning Improvement 2017 Core team 2019 BUs Implement time-critical elements Implement full plan Clinical Supply chain Notified Bodies QMS dossiers Page 33 Copyright Qserve Group B.V.
34 6 - Regulatory Training Awareness, webbinars, F2F training & workshops A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright Qserve Group B.V.
35 Communicate repeatedly. Create awareness Sharepoint Internal website Newsletters Town hall meetings Training and workshops Workshops at the start of task force projects Workshops to focus on the new philosophy of regulatory continued improvement Training on all new processes Webbinars Many topics Frequent Growing knowledge in Board Awareness workshops Budget workshops Page 35 Copyright Qserve Group B.V.
36 Training is essential to keep the pace GAP Verification Finetuning Improvement 2017 Core team 2019 Implement time-critical elements Implement full plan training coordination monitoring balancing alignment meetings communication Page 36 Copyright Qserve Group B.V.
37 7 - Implementation The big TEAM work A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright Qserve Group B.V.
38 PROJECT EXECUTION PROGRAM MANAGEMENT Program Governance Structure Steering Committee TBD Program Manager TBD Program Assistant TBD Pre-market QMS Clinical Evaluation Manufacturing upstream supply PMS Downstream supply UDI Legal xxx Page 38 Copyright Qserve Group B.V.
39 Resources divided over taskforces Project Manager Project Team PRE-market Name Names QMS Clinical evaluation Manufacturing and upstream supply PMS Downstream supply UDI Name Name Name Name name Name Names Names Names names Names Names Backfill with Qserve support Legal name Names xxx Name Names Page 39 Copyright Qserve Group B.V.
40 Project Charter : Pre-market (example) BACKGROUND AND CURRENT STATUS FUTURE STATE TO BE ISSUES/SOURCE xxx OBJECTIVES xxx RISK / IMPACT ON BUSINESS xxx CURRENT STATUS TBD SCOPE DESCRIPTION All technical files of COMPANY DELIVERABLES 1. Xxx 2. Yyy 3. Zzz SUCCESS DESCRIPTION Xxx Abc TEAM NEXT MAJOR MILESTONES - TIMELINE Project Manager: TBD Project Team: TBD Qserve Consultant: Susan Klymowski Tasks Kick-off Workshop categorization suppliers on regulatory/quality risk level Due date Page 40 Copyright Qserve Group B.V.
41 Integration - continuous improvement cycle - PDCA RM QMS PMS CER Page 41 Copyright Qserve Group B.V.
42 Challenges Resources: Staff Budget Patients Investigators Internal commitment Board level Management level Staff level I choose a lazy person to do a hard job because a lazy person will find an easy way to do it Bill Gates Page 42 Copyright Qserve Group B.V.
43 Implementation 2017 Clinical Supply chain Notified Bodies Core team Implement time-critical elements Implement full plan 2019 BUs QMS dossiers Page 43 Copyright Qserve Group B.V.
44 8 - Effectiveness check Time for self reflection and final improvements A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright Qserve Group B.V.
45 A moment of self reflection Self reflections Effectiveness check on revised processes and procedures Effectiveness check on training of staff Internal audit Mock audit (optional) Management review Notified Body Compliance audit Finetuning and CAPA close-out MDR certification!! Page 45 Copyright Qserve Group B.V.
46 The full process Implementing acts Dossiers QMS Portfolio assessment 2017 Clinical Supply chain Notified Bodies training Steering Committee Program Management Taskforces, BUs Includes RoW registrations as input to rationalization decisions Internal audits Mock audits Notified Body audits and assessments GAP Verification Finetuning Improvement Core team 2019 BUs Implement time-critical elements Implement full plan QMS dossiers coordination monitoring balancing alignment meetings communication Implementing and delegated acts Page 46 Copyright Qserve Group B.V.
47 Summarizing A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright Qserve Group B.V.
48 In short Rights Trend analysis and responsibilities of stakeholders Page 48 Copyright Qserve Group B.V. COMMON SPECIFICATIONS REPROCESSING of SUD Non-viable human cells/ tissues Scrutiny Traceability
49 Change in culture might be essential management QA production NB public Distribution chain D&D users patients marketing sales logistics Working together towards strong and timely EU-MDR compliance!! Page 49 Copyright Qserve Group B.V.
50 In conclusion Understand environment, sense of urgency 2. High level review 3. Rationalisation and choice of focus 4. Balance EU versus RoW regulatory status and market share 5. Strategic planning and commitment 6. Awareness, webbinars, F2F training & workshops 7. The big TEAM work 8. Time for self reflection and final improvements 9. Timely MDR certification Page 50 Copyright Qserve Group B.V.
51 Thank you for your attention A global leading medical device consultancy group Europe - Amsterdam (HQ) USA - Boston - San Francisco China Nanjing Copyright Qserve Group B.V.
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