understanding the transition provisions, re -certification ... · slide 1 understanding the...

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Understanding the Transition Provisions, Re-Certification and Reclassification Components of MDR

December 5th, 2017

Ibim Tariah Ph.D

BSI Group Americas Inc.

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1. Roles in the regulatory system:– European Union: Commission, Parliament, Council.– Member States– Notified Bodies– Economic Operators: Manufacturers, EU Reps, Importers & Distributors

2. Summary of MDR CE Marking Process:– Process Overview– Classification Rules / Conformity Assessments– GSPR’s– Harmonized Standards & Common Specifications

3. Notified Body Designation & Transition Provisions:– Designation process– Transition provisions– Conclusions

This Presentation:

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History

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The EU’s Medical Device Regulations History

2008

2012

2014 Q2

2015 Q3

2015 Q4

May 2017

EU Commission launches consultation on MD framework

EU Commission publishes proposal for new MD Regulations

EU Parliament adopts position on MDR

EU Council adopts position on proposed Regulations

Trilogues between Commission, Parliament and Council starts

Publication of Drafts: MDR and IVDR 2016 Q2/2017 Q1

Publication of MDR and IVDR in EUOJ

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Regulation (EU) 2017/745

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Roles in the Regulatory System

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European Commission, Parliament, Council

Member States EU, EEA, EFTA, Customs

Union, MRANotified Bodies

ManufacturerSuppliers

SubcontractorsEU Authorised Representative

ImporterDistributor

New Legislative Framework

2016 Actors – What do they do? Blue Guide

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AdministrationDevelopment comprehensive,

coherent and proportionate legislation

Support Member States, Ensure co-operation between NBs,

Harmonised Standards, NANDO

National Law EnforcementEnsure only safe, compliant

products on marketDesignate Notified Bodies

Conformity AssessmentQMS, Product, Unannounced

Manufacturer, Suppliers, Subcontractor

‘… ultimate responsibility for conformity …’

Market Surveillance

New Legislative Framework

2016 Actors – What do they do? Blue Guide

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How to Read 177 pages of (EU) 2017/745…..

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101 Whereas…

Why

X Chapters of 123 Articles

What

XVI Annexes

How

I. Scope and DefinitionsII. Making available on the market and putting

into service, obligations of economic operators, reprocessing, CE marking, free movement

III. Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices

IV. Notified BodiesV. Classification and conformity assessmentVI. Clinical evaluation and clinical investigationsVII. Post-market surveillance, vigilance and market

surveillanceVIII. Cooperation between Member states, Medical

Device Coordination Group, expert laboratories, expert panels and device registers

IX. Confidentiality, data protection, funding and penalties

X. Final Provisions

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XVII AnnexesI. General Safety and Performance RequirementsII. Technical DocumentationIII. Technical Documentation on Post-Market SurveillanceIV. EU Declaration of ConformityV. CE Marking of ConformityVI. Information to be submitted with registration of devices

and economic operators and core data elements to be provided to the UDI data-base

VII. Requirements to be met by Notified BodiesVIII. Classification RulesIX. Conformity Assessment – QMS & Technical

DocumentationX. Conformity Assessment – Type ExaminationXI. Conformity Assessment – Product Conformity

VerificationXII. Certificates issued by a Notified BodyXIII. Procedure for Custom-made DevicesXIV. Clinical Evaluation and Post-market clinical follow-upXV. Clinical InvestigationsXVI. List of groups of products without an intended medical

purposeXVII.Correlation Table

101 Whereas…

Why

X Chapters of 123 Articles

What

XVII Annexes

How

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Implementing and Delegated Acts

• Many instances of delegated acts and implementing actsnecessary to makeMDR “operational”

• Unclear when thesewill be available…

e.g:• Regulatory status of groups of

products• Common Specifications• Format of Summary of Safety and

Performance• UDI• EUDAMED• List of NBOG codes• NB designation procedure

…

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Copyright © 2016 BSI. All rights reserved.

MDR Key Changes:

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• Strengthened Designation Criteria• Joint Audits: Three Member States and

Commission (FHAA)• Unannounced audits

Notified Bodies

• Less Equivalence, More Data for High Risk Devices

• Publish Safety and Performance Data• Post Market Clinical Follow-up

Clinical Evidence

• Scrutiny for High Risk Devices• Common Specifications• Responsible Person for Manufacturers and

Authorised RepresentativesPre-market

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• Central Database and Co-ordination• Trend Reporting• Enforcement Activities

Post-Market Surveillance and

Vigilance

• Devices and Economic Operators Registered Centrally

• Unique Device Identification (UDI)• Implant Cards

Transparency and Traceability

• Central Committee: MDCG• Expert Panel, Expert Laboratories

Governance and Oversight

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Electronic System on

Registration/ Conformity Assessment

Applications + Summary of Safety and

Clinical Performance

Electronic System on UDI

Electronic System on Certificates

(issued, reissued, refused,

suspended, withdrawn)

Electronic System on Vigilance

(incidents, FSCA, FSN)

+ Periodic Safety Update

Report

Electronic System on

Market Surveillance(measures taken

by Member States)

Electronic System on

Clinical Investigations

(sponsors, description of investigational

device, comparators,

purpose, status)

EUDAMED

Electronic System on Registration –Manufacturers & Authorised Representatives – SRN

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MDR ClassificationAnnex VIII

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Classification Rules – MDR, Annex VIII

MDR MDDRules 1 – 4: Non-invasive devices

Rules 5 – 8 : Invasive devices

Rules 9 – 13 : Active Devices

Rules 14 – 22 : Special rules

Rules 1 – 4 : Non-invasive devices

Rules 5 – 8 : Invasive devices

Rules 9 – 12 : Active devices

Rules 13 – 18 : Special rules

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Summary of MDR CE Marking Process

Copyright © 2016 BSI. All rights reserved.

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1. Check Device is within Scope of MDR (Chapter I, Articles 1, 2, Annex XVI)

2. Determine “Device Class” (Chapter V, Article 51, Annex VIII)

3. Select “Conformity Assessment Procedure” (Chapter V, Article 52)

4. Identify Applicable “Safety and Performance Requirements” (Chapter II, Article 5, Annex I)

5. Assign UDI (Chapter III, Article 27, Annex VI)

6. Assemble “Technical Documentation” (Annex I => Annex II, Annex XV)

7. Apply Conformity Assessment Procedure (Annexes IX, X, XIA or XIB)

8. Complete “Declaration of Conformity” (Chapter II, Article 19, Annex IV)

9. Affix “CE Mark” (Chapter II, Article 20, Annex V)

10. Post Market Surveillance & Updates Technical Documentation (Chapter VII, Articles 83 to 86, Annex XIV => Annex III)

MDR CE marking on a single slide

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Competent Authority Assessment

Notified Body Conformity Assessment

Self-Certification

Class III

Class IIb

RiskClass IIa

Class Im /Is

Class ICustom Made

Classification & Conformity Assessment – MDD

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Commission Assessment

Competent Authority Assessment

Notified Body Conformity Assessment

Self-Certification

Class III Custom Made Implants

Class Ir

Class III ImplantsClass IIb active – administer

medicine

Class III

Class IIb

RiskClass IIa

Class Im /Is

Class ICustom Made

Class IIb Implants

Classification & Conformity Assessment – MDR

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Annex I – GSPR’s• The General Safety And Performance Requirements serve an

analogous function to the Annex I Essential Requirements in the MDD

• The are 3 major chapters– I. General requirements (1 to 9)– II. Requirements regarding design and manufacture (10 to 22)– III. Requirements regarding the information supplied with the

device (23)

• Chapter II has a large number of subsections

23

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• Devices in conformity with the relevant harmonized standards, or the relevant parts of those standards (published in the Official Journal) are presumed to in conformity with those requirements of this Regulation [Article 8]

• In some cases (such as no or insufficient harmonized standard) the Commission may adopt common specifications (CS) [Article 9]

– Common specification (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.

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Harmonized Standards and Common Specifications

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2007 – 2024 EU Regulations

25

Time

Req

uire

men

ts

Interim Regulations & Recommendations

Future Regulation

2017

UnannouncedAudits

Joint Assessments

Clinical Oversight

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NB’s Designation under the MDR

Copyright © 2016 BSI. All rights reserved.

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26 November 2017

✔

EU MDR / IVDR – Designation – Article 38-40 / 38-40

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Transition Provisions (Article 120 of MDR)

Copyright © 2016 BSI. All rights reserved.

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MDR Transition (Article 120)

05 May 2017Adoption of MDR

Entry into Force (OJEC + 20days)(25 May 2017)

NBs designation under MDR

Date of Application(26 May 2020)

Last MDD/AIMD certificates expire

(27 May 2024)

MDD/AIMD certificate validity(4 years )

MDD/AIMD certificates (max 5-year expiry from issue/renewal date)

MDR certificates

Transition period 3 years

Annex IV certificates expire (27 May 2022)

27 May 2025No more « placing on the

market » of devices covered by MDD/AIMD certificates

NB’s Designation Application (26 Nov 2017)

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MDR Transition (Article 120)

Adoption of MDR05 May 2017

Entry in to Force 25 May 2017

NBs designationunder MDR

MDD/AIMDD certificate validity(4 years )

MDD/AIMDD certificates can be issued/re-issued/renewed

MDR certificates

Transition period3 years

MDD/AIMDD Annex IV certificatesvoid on 27 May 2022

No more « making availableor putting into service » of

devices covered by MDD/AIMDD certificates

MDD/AIMDD certificates void27 May 2024

27 May 2025

NBs can apply for designation26 Nov 2017

• No significant chang purpose

• Post market surveilla• Market surveillance• Vigilance• Registration of econo

Date of Application26 May 2020

• Class I reusable• Class III custom made implantable• Devices with no Medical Purpose (Once Common

Specifications are available)

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MDR Transition (Article 120)

However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives.

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The Clock is Ticking!• What products currently on the EU market?

• What products on the market post 2024?

• What needs certification in 2022 / 2024?

• What is ‘in’ the MDR that wasn’t previously? i.e. Will need CE Certification sooner?

• What is reclassified?

• What are your priority products?

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• Become familiar with MDR. • Conduct MDR impact assessment on your business.• Create Work Groups for key sections.• Plan how to:

Maintain MDD in your organization till end of grace period. Implement MDR in your organization. Handle Significant changes & Intended Use changes from Date of Application Implementation of PMS, Vigilance, Registration, Incident Reporting and

Responsible Person from Date of Application.• Hire competent people.

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Conclusions:

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Thank You….