NEW MDR Regulatory Context. NEW MDR Regulatory Context.

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Presentation transcript:

NEW MDR Regulatory Context

NEW MDR Regulatory Context MODERNIZED

NEW MDR Regulatory Context MORE ROBUST

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

1 TWO NEW 2017/745 3 YEARS Regulations 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 3 YEARS Applies only after transitional period of

2 TWO NEW 2017/746 5 YEARS Regulations 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 5 YEARS Applies only after transitional period of

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

CONTEXT 2007 MDR Regulatory ‘ 2007 ‘92 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

CONTEXT 2010 MDR Regulatory ‘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

CONTEXT 2012 MDR Regulatory ‘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

CONTEXT 2017 MDR Regulatory ‘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

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

CONTEXT High risk devices New MDR Regulatory Stricter ex ante control of High risk devices

CONTEXT Designation & processes New MDR Regulatory Reinforcement of the criteria covering Designation & processes for oversight by notified bodies

New MDR Regulatory CONTEXT Inclusion of certain Aesthetic devices

CONTEXT Classification SYSTEM New MDR Regulatory Introduction of a new risk Classification SYSTEM

New MDR Regulatory CONTEXT Improved transparency

New MDR Regulatory CONTEXT Introduction of an Implant card

CONTEXT Clinical evidence New MDR Regulatory Reinforcement of the rules on Clinical evidence

CONTEXT Surveillance Requirements New MDR Regulatory Strengthening of postmarketing Surveillance Requirements

New MDR Regulatory CONTEXT Improved Coordination mechanisms

New MDR Regulatory CONTEXT More Information available

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

Face more liability IMPACT of new regulations on manufacturers

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

improve data management IMPACT Have to improve data management IMPACT of new regulations on manufacturers

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

Prepare supply chains for unannounced audits COMPLIANCE Addressing MDR

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

Manufacturers should thoroughly assess entire device portfolios Addressing MDR COMPLIANCE

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

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

COMPLIANCE STRATEGIES that plan for TRANSITION Addressing MDR Strongly recommended: Addressing MDR COMPLIANCE

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

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

TIMELINE Complex MDR 25 May 2019 25 May 2020 27 May 2022 26 May 2024 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 Other certificates issued under current directives that have not yet expired will become void 26 May 2025 Devices CE Marked under the MDD or AIMDD may no longer be marketed or put into service in Europe

EUDAMED MDR timeline also dependent on functionality of 25 May 2020 25 Regulation related to EUDAMED and the UDI database 25 Nov 2020 Registration obligation in EUDAMED (registration of product, test certificates) (18 months later) 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

GREAT OPPORTUNITY AHEAD 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 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.