EU MDR: Review of Significant Changes and Timeline for Manufacturers. 12 December 2017 ASQ NEBG RAPS MASSMEDIC Waltham Woods

Transcription

1 EU MDR: Review of Significant Changes and Timeline for Manufacturers 12 December 2017 ASQ NEBG RAPS MASSMEDIC Waltham Woods Glen Emelock Sr. Partner, The CRO Group Lead Auditor, Product Reviewer, NSAI

2 The Fine Print All opinions expressed by Glen Emelock during and after this presentation are solely his and do not reflect the opinions of ASQ, RAPS, MassMedic, NSAI, or affiliates, and may have been previously disseminated by him in other presentations, or on the Internet or via another medium. You should not treat any opinion expressed by Glen as a specific requirement for certification or approval or part of a particular regulatory strategy for such certification or approval, but only as an expression of his opinion. Glen s opinions are based upon information he considers reliable, but neither ASQ, RAPS, MassMedic, NSAI, nor affiliates and/or subsidiaries warrant the completeness or accuracy, and it should not be relied upon as such. Emelock, ASQ, RAPS, MassMedic, NSAI, and affiliates and/or subsidiaries are not under any obligation to update or correct any information provided during this presentation. This (short) presentation is intended to provide a general overview of the European Medical Device Regulation. As such, it cannot address all requirements of the EU MDR, and thus, the information presented including but not limited to a sample of regulatory requirements, standards, guidances, and related information mentioned should be carefully reviewed and considered as part of a baseline towards establishing an overall, well-balanced plan to address applicable essential requirements appropriate for your specific situation.

3 A brief overview on the MDR A Notified Body Perspective Agenda A Manufacturer/Consultant Perspective Timelines Some Unanswered Issues

4 History Stats A Brief Overview on the MDR Objectives Main Changes Certificately Yours

5 A Brief Overview on the MDR - History : EU Commission begins consultation on framework for Directive revision - Oct. 2015: Member States agree on general approach to revision - Mar. 2017: Member State representatives agree to adopt regulations to replace AIMD, MDD, and IVDD - 05 May 2017: Publication of MDR (to replace AIMD and MDD) and IVDR (to replace IVDD) but dated 5 Apr May 2017: First date of application of MDR/IVDR, transition period 3 years for MDR, 5 years for IVDR (before going mandatory)

6 A Brief History on the MDR - Stats Medical Devices Directive CD 93/42/EEC, amended by CD2007/47EC 20 Articles 60 Pages 12 Annexes Doesn t Cover AIMD Doesn t Cover non-medical devices (do not diagnose or treat a disease, ex. hair removal, regrowth) Medical Device Regulation Regulation 2017/ Articles 175 Pages 17 Annexes Covers AIMD (Active Implantable Medical Devices) Covers certain non-medical devices (aesthetic beauty photooptical)

7 Increased / more consistent Notified Body Controls and Operations A Brief Overview on the MDR Objectives Increased / more consistent Vigilance Reporting Bolster Post Market Surveillance (Unannounced Inspections, PMCF, etc.) Improved Information Sharing via Eudamed (Comp Authorities, Notified Bodies)

8 A Brief Overview on the MDR Main Changes - One regulation covers AIMD and Medical Devices - Covers non-medical devices (ex. cosmetic contact lens) - Formalizes Recommendation/Guidance Creep of past 4 years - Reclassifies devices with provocative safety - New definitions bring new players (Economic Operator), devices (those with Nanomaterials), etc. into scope - Will lead to a Notified Body consolidation - Keeping up with the FDA-ers (ex. UDI, regulates non-medical, etc., more regulation of re-usables) - UA s from randomly every 3 to every 5 years

9 A Brief Overview on the MDR Certificately Yours - MDD or AIMD Certificates issued before MDR (26 May 2017) have up to 5 year expiry (the date on the Cert except AIMD /MDD Annex IV which expire 27 May 2022 at latest) - MDD or AIMD Certificates issued during transition (26 May May 2020) have up to a 5 year expiry, but NLT 27 May Notified Bodies may not issue MDD certificates after 26 May If MDR Certification not achieved during transition, and MDD Cert expires, Manufacturer must not place devices on market after 26 May 2025.

10 Applying for Redesignation Resources Assessment Transparency A Notified Body Perspective NANDOGEDDON Getting a Grip on Rule 11 Technical File / Design Dossier Re-Review Meet the Panels EUDAMD And then there s. lift-off

11 Applying for Redesignation - All NBs must apply no grandfathering - Applications were accepted starting 26 Nov Per Team-NB, ~84% already applied, 8% Dec, 8% in Redesignation (or Death) by Code (see Resources) - Timing is everything Early Complete Applications May Get Biz - Some NBs didn t get Codes (there are a lot of new ones) until 24 Nov - Scheduling redesignation joint assessments - Redesignation estimated at 18 months

12 Resources - NBs must have technical competence for all the Codes, but can use external staff - BUT NBs must have permanent, sufficient administrative, technical, and scientific staff, and oversee assessments by externals - Expertise for new devices (cosmetic contacts, aesthetic IPLs, etc.) - Define staff assessment qualification (products, QMS, post-market) - NB s shall employ device reviewers with sufficient clinical expertise and, if necessary, use external clinical experts with direct and current experience relating to the device in question or the clinical condition in which it is utilised, for the purposes of that review. - Much more to review/assess (PSUR, UDI, Unannounced Inspections)

13 Assessment Transparency - NBs must have technical competence for all the Codes, but can use external staff - BUT NBs must have permanent, sufficient administrative, technical, and scientific staff, and oversee assessments by externals

14 NANDOGeddon - New Approach Notified and Designated Organisations - Notified bodies are designated by their national Designating Authority (ex. in Ireland, the HPRA) as competent to assess the conformity of particular device types which are identified by scope codes such as MD Nonactive soft tissue implants, MD Devices for wound care, MDS Medical devices incorporating medicinal substances or MDS Medical devices utilising tissues of animal origin. The scope codes for the existing Directives are set out on the European Commission s NANDO website. - All notified bodies which are designated to assess medical devices are listed on the EU Commission s NANDO website which can be referred to for an up-to-date listing. As part of the designation process, notified bodies listed on this website undergo a national designation assessment and an independent assessment by experts from EU authorities and the EU Commission.

15 NANDOGeddon - Redesignation to a NANDO code involves: - Product Reviewers familiar with the applicable harmonized standards - (ex. AIMD, EN 45502, anything electrical, EN 60601, etc.) - Assessors familiar with the QMS (design, production, QA) for those products - Lots of New Codes and Device Changes: - From 3 AIMD and 38 MDD Codes to 71 MDR Codes - From 35 IVDD to 80 IVDR Codes

16 NANDOGeddon - Lots of New Codes and Device Changes: - Standalone Software class now linked to risk (Rule 11) MDS1009 and MDA0315 under MDR, IVS1009 and IVS1010 under IVDR - Products without a medical purpose (Annex XVI) not Coded as such - (hair removal IPL MDA 0202, MDA 0302, or MDA 0318) - Spinal Products (Rule 8) not Coded as Such - Reusable surgical devices (Article 7c) may be coded

17 Getting a Grip on Rule 11 - Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa, except if such decisions have an impact that may cause: death or an irreversible deterioration of a person's state of health, in which case it is in class III; or a serious deterioration of a person's state of health or a surgical intervention, in which case it is classified as class IIb.

18 Getting a Grip on Rule 11 - Most Class I SaMD under MDD will be IIA or IIB under MDR: SaMD Example MDD Class MDR Class Did I take my Med? App I IIA, IIB, or III Suggesting/influencing dx App I IIA, IIB, or III Predicting OSA App I IIA

19 Technical File / Design Dossier Re-review - All Technical Files / Design Dossiers must be re-reviewed - Legal manufacturer (the one placing product on the market) must have FULL ACCESS to OBL manufacturer technical documentation, and that to Legal Manufacturer s Notified Body - TFs/DDs reviewed against Common Specifications (CS) once adopted and applicable for that device type (includes Annex XVI non-medical purpose) - CERs reviewed against current requirements (ex. MED DEV 2.7/1 Rev 4 (or 5 or ) Clinical evaluation is a permanent process that must be covered by plans and reports. NBs will assess plans, procedures and results taking into account state of the art documented in CERs and other evidence per Article 61 and Annex XIV. - Periodic Safety Update Reports (PSURs) Article 86 (IIA=2 yrs, IIB/III=annual) - Piece of cake, that is until you.

20 Meet the Panels - Expert panels for certain Class IIB and III devices under review - For class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product, notified bodies should, except in certain cases, be obliged to request expert panels to scrutinise their clinical evaluation assessment report. Competent authorities should be informed about devices that have been granted a certificate following a conformity assessment procedure involving an expert panel. The consultation of expert panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-risk medical devices by sharing expertise on clinical aspects and developing CS on categories of devices that have undergone that consultation process. - Manufacturers should have access to expert panels prior to clinical evaluation - Panels will be established on or before 26 May 2020

21 And then there s - Not clear if NB staff qualification/authorization process, criteria for when specialist input/review required, other past NB proprietary processes are subject to CA assessment/corrective action required - NB assessments of drug/device combos SSDD (product reviews & QMS just of device part or also QMS of the pharma entity (especially if they release product to EU Market) - Brexit has MDR Impact Assessment on Hold Will UK Competent Authority, Remaining NBs, all new Economic Operators, all manufacturers with UK NBs or ARs comply with MDR on time? - QMS Perfect Storm EN 13485:2016 doesn t address all MDR QMS requirements, standard revision and transition vs. MDR timelines

22 What CE Marked devices after 25 May 2025? What non-medical after 25 May 2020? A Manufacturer /Consultant Perspective Have Tech Files / Dossiers kept up? What s the Product/QMS Reassessment Schedule Is your current NB going to be there? Is your current NB going to be redesignated Will redesignation include your NANDOs And then there s.

23 And then there s - Many NBs backlogged services requiring senior/tech staff to get the MDR redesignation in as early as possible. - A handful of NBs continue backlogging as they now turn attention to IVDR redesignation application - Backlogs will continue as NBs prep for Redesignation Joint Assessments - Some NBs pre-applying MDR changes when it suits (pressure from CA, part of previous CA/redez audit finding, etc.) - Some NBs already shuttering parts of biz / NANDO Codes - Less NBs, more tech files = longer review times, more Euros - Lots of SaMD previously Class I now in IIA, IIB, or III NB resources - How does mfr get access to expert panel the NB uses BEFORE the CER?

24 MDR /IVDR Transition technically starts EUDAMED (really) will go live xx May 2019 First NBs complete MDR redesignation process IVDR Transition ends, mandatory phase begins No AIMD, MDD, IVDD devices placed on EU Market Nov Nov May May Timelines May May May 2019 May May MDR & IVDR NB Redesignation Applications accepted xx Nov 2018 First NB Redesignation Joint Assessments MDR Transition ends, mandatory phase begins All AIMD/MDD Certs no longer valid

25 MDR /IVDR Transition technically starts EUDAMED (really) will go live xx May 2019 First NBs complete MDR redesignation process IVDR Transition ends, mandatory phase begins No AIMD, MDD, IVDD devices placed on EU Market Nov ISO 13485: 2016 Cert Mandatory Nov May May Timelines May May May 2019 May May MDR & IVDR NB Redesignation Applications accepted xx Nov 2018 First NB Redesignation Joint Assessments MDR Transition ends, mandatory phase begins All AIMD/MDD Certs no longer valid

26 Some Additional Unanswered Issues - No Reward for NBs Sticking Their Neck Out - Competent Authority Consistency in Redesignation - Expert Panel Conundrum - (Smooth) Economic Operators - But wait there s more

27 No Reward for NBs Sticking Their Neck Out - The Writing On The Wall: Some NBs have already announced reduction in scope for certain NANDOs under AIMD, MDD, IVDD - Avoiding Biting Off More: Many IVD NBs not expected to apply for redesignation when 80% of current IVDs not requiring NB review are going to need it (IVDR Class B, C, or D) - Many MDD NBs may limit redesignation scope for high risk devices - More and more SaMD devices and Rule 11 will make NBs very busy - As we approach pull off market day, remaining NB queues expected to grow

28 Competent Authority Consistency in Redesignation - What happens during Joint Redesignation Assessments when the peer Competent Authority notices they have a better handle on the assessment than the hosting Competent Authority? - What happens during Joint Redesignation Assessments when, after 3 rd assessment the assessors realise NB#1 s Vigilance was subpar? - Scheduling of Joint Assessment Resources particularly under IVDR where # of NBs is few, Joint Assessors outnumber Vic NBs.

29 Expert Panels Conundrum - What happens if your NB is told they should have used an Expert Panel and didn t? - What happens if Expert Panel for your device type is not established until AFTER you submit your CER but while Dossier/TF is being reviewed? - Notified Bodies assess manufacturers, Competent Authorities assess Notified Bodies who assesses Expert Panels and how? - Expert panel language includes should, not shall is it suggestion or a typo? - Expert panels may charge fees suppose a NB acquires a EP how is impartiality assured?

30 (Smooth) Economic Operators - Economic Operator means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) (Procedure Packs) and 22(3) (Parts and Components); - Maybe subject to Conformity Assessments and Unannounced Inspections as well as their suppliers or subcontractors - Shall cooperate with Competent Authorities - Maybe subject to UDI labeling, registration, EUDAMED - Under MDD, ISO or even ISO 9001 was adequate - Another thing for NB to review during product/qms assessments

31 But wait there s more - And that was just the past 45 minutes - Please remember, this was just a sample. There s plenty more at: GLOBAL RA UPDATE 19 JUN 2018