EU MDR and IVDR Update - MassMEDIC · overview of the European Medical Device Regulation. As such, it cannot address all requirements of the EU MDR, and thus, the information presented

EU MDR: Review of Significant Changes and Timeline for Manufacturers12 December 2017ASQ NEBG – RAPS – MASSMEDICWaltham Woods

Glen Emelock

Sr. Partner, The CRO Group

Lead Auditor, Product Reviewer, NSAI

© 2017, All rights reserved. The CRO Group, Inc.

The Fine PrintAll 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.


Agenda

A brief overview on the MDR

A Notified Body Perspective

A Manufacturer/Consultant Perspective

Timelines

Some Unanswered Issues


A Brief Overview on the MDR

History

Stats

Objectives

Main Changes

Certificately Yours


A Brief Overview on the MDR - History- 2008: 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 2017

- 26 May 2017: First date of ‘application’ of MDR/IVDR, transition period 3 years for MDR, 5 years for IVDR (before going mandatory)


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 2017/745

• 123 Articles

• 175 Pages

• 17 Annexes

• Covers AIMD (Active Implantable Medical Devices)

• Covers certain non-medical devices (aesthetic beauty photooptical)

A Brief Overview on the MDR –Objectives

Increased / more consistent Notified Body Controls and Operations

Increased / more consistent Vigilance Reporting

Bolster Post Market Surveillance (Unannounced Inspections, PMCF, etc.)

Improved Information Sharing via Eudamed(Comp Authorities, Notified Bodies)


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


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 2017 – 26 May 2020) have up to a 5 year expiry, but NLT 27 May 2024

- Notified Bodies may not issue MDD certificates after 26 May 2020

- If MDR Certification not achieved during transition, and MDD Cert expires, Manufacturer must not place devices on market after 26 May 2025.


A Notified Body Perspective

Applying for Redesignation

Resources

Assessment Transparency

NANDOGEDDON

Getting a Grip on Rule 11

Technical File / Design Dossier Re-Review

Meet the Panels

EUDAMD lift-offAnd then there’s….


Applying for Redesignation

- All NBs must apply – no grandfathering

- Applications were accepted starting 26 Nov 2017

- Per Team-NB, ~84% already applied, 8% Dec, 8% in 2018

- 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


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)


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


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 0204 - Non-active soft tissue implants, MD 0300 - Devices for wound care, MDS 7001 -Medical devices incorporating medicinal substances or MDS 7002 - 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.


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


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



- 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.



- 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


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….


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 harmonisedevaluation 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


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


A Manufacturer/Consultant Perspective

What CE Marked devices after 25 May 2025?

What ‘non-medical’ after 25 May 2020?

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….


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?


TimelinesMay 26

2017

MDR /IVDR Transition technically starts

Nov. 26 2017

MDR & IVDR NB Redesignation Applications accepted

May 20 2018

EUDAMED (really) will go live

Nov. 2018

xx Nov 2018 –First NB Redesignation Joint Assessments

May 2019

xx May 2019 –First NBs complete MDR redesignation process

May 25 2020

MDR Transition ends, mandatory phase begins

May 25 2022

IVDR Transition ends, mandatory phase begins

May 27 2024

All AIMD/MDD Certs no longer valid

May 27 2025

No AIMD, MDD, IVDD devices placed on EU Market


TimelinesMay 26

2017

MDR /IVDR Transition technically starts

Nov. 26 2017

MDR & IVDR NB Redesignation Applications accepted

May 20 2018

EUDAMED (really) will go live

Nov. 2018

xx Nov 2018 –First NB Redesignation Joint Assessments

May 2019

xx May 2019 –First NBs complete MDR redesignation process

May 25 2020

MDR Transition ends, mandatory phase begins

May 25 2022

IVDR Transition ends, mandatory phase begins

May 27 2024

All AIMD/MDD Certs no longer valid

May 27 2025

No AIMD, MDD, IVDD devices placed on EU Market


ISO 13485: 2016 Cert Mandatory

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


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


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 3rd 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.


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?


(Smooth) Economic Operators

- ‘Economic Operator’ means a manufacturer, an authorisedrepresentative, 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 13485 or even ISO 9001 was adequate

- Another thing for NB to review during product/QMS assessments


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


Documents

EU MDR and IVDR Update - MassMEDIC · overview of the European Medical Device Regulation. As such, it cannot address all requirements of the EU MDR, and thus, the information presented