NEW MDR Regulatory Context NEW MDR Regulatory Context

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NEW MDR Regulatory Context

NEW MDR Regulatory Context

NEW MDR Regulatory Context MODERNIZED

NEW MDR Regulatory Context MODERNIZED

NEW MDR Regulatory Context MORE ROBUST

NEW MDR Regulatory Context MORE ROBUST

NEW MDR Regulatory Context BETTER PROTECTION of public health and patient safety

NEW MDR Regulatory Context BETTER PROTECTION of public health and patient safety

TWO NEW Regulations 1 REGULATION (EU) 2017/745 of the European Parliament and the European

TWO NEW Regulations 1 REGULATION (EU) 2017/745 of the European Parliament and the European Council of 5 April 2017 on MDs, amending Directive 2001/83/EC, Regulation (EC) No 178/2002, and Regulation (EC) No 1223/2009 and repealing European Council Directives 90/385/EEC and 93/42/EEC Applies only after transitional period of 3 YEARS

TWO NEW Regulations 2 REGULATION (EU) 2017/746 of the European Parliament and the European

TWO NEW Regulations 2 REGULATION (EU) 2017/746 of the European Parliament and the European Council of 5 April 2017 on in vitro diagnostic medical devices (IVMDs) repealing Directive 98/79/EC and Commission Decision 2010/227/EU Applies only after transitional period of 5 YEARS

MDR Regulatory CONTEXT ‘ 92 1992 Introduction of AIMD Directive (90/385/EEC) and MD Directive

MDR Regulatory CONTEXT ‘ 92 1992 Introduction of AIMD Directive (90/385/EEC) and MD Directive (93/42/EEC)

MDR Regulatory CONTEXT ‘ 92 ‘ 2007 Directive 2007/47/EC modified the Medical Devices Directive

MDR Regulatory CONTEXT ‘ 92 ‘ 2007 Directive 2007/47/EC modified the Medical Devices Directive (MDD) and the active implantable medical device (AIMD) in an attempt to address the weaknesses and concerns of previous directives

MDR Regulatory CONTEXT ‘ 92 ‘ 07 2010 Scandal involving defective breast implants manufactured

MDR Regulatory CONTEXT ‘ 92 ‘ 07 2010 Scandal involving defective breast implants manufactured by Poly Implant Prothèse in France, which surfaced in 2010 and which demonstrated additional structural weaknesses in the system

MDR Regulatory CONTEXT ‘ 92 ‘ 07 ‘ 10 2012 September: European Commission published

MDR Regulatory CONTEXT ‘ 92 ‘ 07 ‘ 10 2012 September: European Commission published proposals for MDR 2017/745 and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. Discussion between the European Commission, the European Parliament, and the European Council compromises text in June 2016 and translation into all European Union languages by September-October 2016

MDR Regulatory CONTEXT ‘ 92 ‘ 07 ‘ 10 ‘ 12 2017 New medical

MDR Regulatory CONTEXT ‘ 92 ‘ 07 ‘ 10 ‘ 12 2017 New medical device regulations (MDRs) (2017/745) were formally published in the Official Journal of the European Union in May 2017, heralding the official transitional period

MDR Regulatory CONTEXT ‘ 92 ‘ 07 ‘ 10 ‘ 12 ‘ 17 2020

MDR Regulatory CONTEXT ‘ 92 ‘ 07 ‘ 10 ‘ 12 ‘ 17 2020 Full implementation of MDR 2017/745 in May 2020

New MDR Regulatory CONTEXT Stricter ex ante control of HIGH RISK DEVICES

New MDR Regulatory CONTEXT Stricter ex ante control of HIGH RISK DEVICES

New MDR Regulatory CONTEXT Reinforcement of the criteria covering DESIGNATION & PROCESSES for oversight

New MDR Regulatory CONTEXT Reinforcement of the criteria covering DESIGNATION & PROCESSES for oversight by notified bodies

New MDR Regulatory CONTEXT Inclusion of certain AESTHETIC DEVICES

New MDR Regulatory CONTEXT Inclusion of certain AESTHETIC DEVICES

New MDR Regulatory CONTEXT Introduction of a new risk CLASSIFICATION SYSTEM

New MDR Regulatory CONTEXT Introduction of a new risk CLASSIFICATION SYSTEM

New MDR Regulatory CONTEXT Improved TRANSPARENCY

New MDR Regulatory CONTEXT Improved TRANSPARENCY

New MDR Regulatory CONTEXT Introduction of an IMPLANT CARD

New MDR Regulatory CONTEXT Introduction of an IMPLANT CARD

New MDR Regulatory CONTEXT Reinforcement of the rules on CLINICAL EVIDENCE

New MDR Regulatory CONTEXT Reinforcement of the rules on CLINICAL EVIDENCE

New MDR Regulatory CONTEXT Strengthening of postmarketing SURVEILLANCE REQUIREMENTS

New MDR Regulatory CONTEXT Strengthening of postmarketing SURVEILLANCE REQUIREMENTS

New MDR Regulatory CONTEXT Improved COORDINATION MECHANISMS

New MDR Regulatory CONTEXT Improved COORDINATION MECHANISMS

New MDR Regulatory CONTEXT More INFORMATION AVAILABLE

New MDR Regulatory CONTEXT More INFORMATION AVAILABLE

7 Stricter premarket control Inclusion of aesthetic products Data on real-life use of devices

7 Stricter premarket control Inclusion of aesthetic products Data on real-life use of devices Oversight by notified bodies Important modifications Implant card European Union database Rules on clinical data

IMPACT of new regulations on manufacturers Face more liability

IMPACT of new regulations on manufacturers Face more liability

IMPACT of new regulations on manufacturers Acquire more clinical data of higher quality

IMPACT of new regulations on manufacturers Acquire more clinical data of higher quality

IMPACT of new regulations on manufacturers Have to improve data management

IMPACT of new regulations on manufacturers Have to improve data management

IMPACT of new regulations on manufacturers Monitor quality and safety throughout the full product

IMPACT of new regulations on manufacturers Monitor quality and safety throughout the full product life cycle

Addressing MDR COMPLIANCE Prepare supply chains for unannounced audits

Addressing MDR COMPLIANCE Prepare supply chains for unannounced audits

Addressing MDR COMPLIANCE Distribution will have a role in vigilance and postmarketing surveillance

Addressing MDR COMPLIANCE Distribution will have a role in vigilance and postmarketing surveillance

Addressing MDR COMPLIANCE Manufacturers should thoroughly assess entire device portfolios

Addressing MDR COMPLIANCE Manufacturers should thoroughly assess entire device portfolios

Addressing MDR COMPLIANCE Supports portfolio assessment and CE dossier preparation to ensure compliance with

Addressing MDR COMPLIANCE Supports portfolio assessment and CE dossier preparation to ensure compliance with the MDR.

Addressing MDR COMPLIANCE EUDAMED planned go-live in 2019. Obliged to report under the MDR

Addressing MDR COMPLIANCE EUDAMED planned go-live in 2019. Obliged to report under the MDR should the EUDAMED not go live before the date of application in May 2020.

Addressing MDR COMPLIANCE Strongly recommended: STRATEGIES that plan for TRANSITION

Addressing MDR COMPLIANCE Strongly recommended: STRATEGIES that plan for TRANSITION

Addressing MDR COMPLIANCE Helps manufacturers BUILD STRATEGIES BASED ON: ü Expiration dates of their

Addressing MDR COMPLIANCE Helps manufacturers BUILD STRATEGIES BASED ON: ü Expiration dates of their CE Marking certificates ü Notified bodies’ policies ü Availability of clinical data ü Expiration dates of devices

Complex MDR TIMELINE 05 May 2017 Publication of new MDR-IVDR 25 May 2017 New

Complex MDR TIMELINE 05 May 2017 Publication of new MDR-IVDR 25 May 2017 New MDRIVDR comes into effect 25 Nov 2017 26 Nov 2017 to 26 May 2020 25 May 2018 Early applicability of regulation concerning notified bodies: notified bodies may apply for MDR designation Notified bodies may issue certificates under the MDD or the AIMDD, with a maximum validity of five years Cooperation of competent authorities and the commission

Complex MDR TIMELINE 25 May 2019 ü ü Notified bodies for UDIs Certificates issued

Complex MDR TIMELINE 25 May 2019 ü ü Notified bodies for UDIs Certificates issued in accordance with AIMDD (Annex 4) and MDD (Annex IV); EC-type verifications that have not yet expired will become void 25 May 2020 Full applicability of regulation; other regulations are nullified 27 May 2022 MDD certificates expire (Annex IV) 26 May 2024 26 May 2025 Other certificates issued under current directives that have not yet expired will become void Devices CE Marked under the MDD or AIMDD may no longer be marketed or put into service in Europe

MDR timeline also dependent on functionality of EUDAMED 25 May 2020 Regulation related to

MDR timeline also dependent on functionality of EUDAMED 25 May 2020 Regulation related to EUDAMED and the UDI database 25 Nov 2020 (18 months later) Registration obligation in EUDAMED (registration of product, test certificates) 25 May 2021 to 25 May 2025 UDI labelling obligation (timeline depending on risk class) 25 May 2023 to 25 May 2025 UDI direct marketing in reusable products

New MDR requires more action from industry = ADDITIONAL BURDEN FOR COMPANIES = EFFICIENT

New MDR requires more action from industry = ADDITIONAL BURDEN FOR COMPANIES = EFFICIENT REGULATORY & QUALITY SERVICES across the MD life cycle GREAT OPPORTUNITY AHEAD

specialises in helping international life sciences organisations more effectively get their products and therapies

specialises in helping international life sciences organisations more effectively get their products and therapies to market by providing those clients with functional support across all of the regulated stages of the product life cycle—from development to launch, to postmarketing.