01 MDR Israel Introduction

…..
the practical approach
The upcoming EU MDR

- key changes – overview
Gert Bos
Executive director & Partner
A global leading medical device consultancy group

Europe - Amsterdam (HQ) | USA - Boston - San Francisco | China – Nanjing
Copyright Qserve Group B.V.
Highlights
• Objectives legal revision

• Highlights on legislative process
• 10 most critical changes
• Timelines moving forward
• Key impact
• Q&A
Page 2 | Copyright Qserve Group B.V. …..the practical approach

Objectives in legislative reform
• Consistently high level of health & safety protection for EU citizens

• Free and fair trade of medical devices throughout the EU
• Adaption to significant technological & scientific progress in the
sector over last 2 decades.
Key elements:
• extending scope • clear rights manufacturers/distributors
• better supervision of notified bodies • stronger requirements medical evidence

Objectives in legislative reform
• Consistently high level of health & safety protection for EU citizens

Sufficient clinical data and performance evaluation results
• Free and fair trade of medical devices throughout the EU
= Clinical Evidence
• Adaption to significant technological & scientific progress in the

sector over last 2 decades.
State of the art
Four charges to improve ad interim
• Functioning notified bodies
• Market surveillance
• Coordination on vigilance
• Communication and
transparency
Living up to MDR/IVDR
2010 2013 2017-2020

Guidance & Audits & equirements &
interpretation supervision transparency
• Updated • Joint inspection • MDR / IVDR

legislation of NBs • Clinical trials
• Updated • UAV system • Special NBs
MEDDEV • COEN • EUDAMED
documents coordination • UDI
• New harmonized
• Supply chain
standards
focus
• State of the art
• And more….

Push on Notified Bodies
• Regulation:
• Re-designation of notified bodies
• Joint assessment teams
• Strong focus on qualification,
independence, clinical evaluation
• Recommendation:
• Strict details on dossier assessment
• Strict details on audits
• Minimum frequency of
unannounced visits

Expected 50% not
Changes to Notified Bodies re-designated or with
significant scope change !
• Regulation on NB designation & recommendation on NB work

• Notified Body number dropped from 87 to 57; IVD-NB relatively stable at
22; expectations for next 6-12 months: 10-15 more to go including some
with IVD scope
• Some remain with reduced scope
• Notified bodies under pressure and scared
• Ongoing initial reviews stifle on growing requirements
on clinical data and limits to equivalence use
• Line-extension reviews getting cumbersome
• Renewal halted; certificates not renewed in time
• Certificates suspended without clear warning
• NBs careful in accepting transfers
• Waiting lists generally increasing
Page 8 | Copyright Qserve Group B.V. MHRA
…..the practical approach
Elements of change – new guidance MEDDEV 2.7.1 rev 4
• Clinical Evaluation Report for all classes of devices

• Benefit risk in intended use / target group
• Aligned with state of art in medical field concerned
• Inclusion of usability requirements
• Integrated in lifecycle management
• Clinical evaluation before and after clinical studies
• Expectation of larger patient numbers in studies
• Stronger focus on analysis and appraisal of data
• Qualification of evaluators
• Update (annually / 2 year / 5 year)
Element of change – shifting view on Own Brand Labeling
• Own Brand Labeler

same requirements as OEM
• Access to full technical file,
including e.g. sterilization validation
at subcontractors of the OEM
• Access to OEM’s PMS data
• Full audit and supply chain
oversight
• Unannounced audits

New MHRA guidance – OBL => virtual manufacturer

Intermezzo: the impact of a Brexit….
• Slow process; will take till Q1 2019

• Uncertainty on future is most critical impact
• Trade agreement?
• Accept new MDR / IVDR – or separate legal
framework?
• Continued notified body services?
• Continued authorized rep services?
• Etc. etc.
Three key stakeholders
Commission (2012) Parliament (2014) Council (2015)

Trilogue Process
• Discussion method for negotiations between Council and EP to reach

political agreement
• No formal rules, it does not exist in the procedures; there is an MoU

between EP and Council
• Trilogues, but mainly negotiations between EP and Council; CIE

‘facilitates’.

Finally MDR is published on May 5 2017

Finally MDR is published on May 5 2017
MDD MDR
20 articles 123 articles
60 pages 175 pages
12 annexes 16 annexes
Directive Regulation
Key elements of change

Regulation EU 2017/745
Chapter I – Scope and Definitions
Chapter II – CE Marking, Economic Operators, Reprocessing
101 Whereas … = Why Chapter III – Identification and Traceability of Devices
Chapter IV – Notified Bodies
10 Chapters of 123 Articles = What
Chapter V – Classification and Conformity Assessment
XVI Annexes = How Chapter VI – Clinical Evaluation and Investigation
Chapter VII – Vigilance and Market Surveillance
Chapter VIII – Cooperation between Member States
Chapter IX – Confidentiality, Data Protection, Funding,
Penalties
Chapter X – Final Provisions

Regulation EU 2017/745
Annex I – General safety and performance requirements
Annex II – Technical Documentation
Annex III – EU Declaration of Conformity
101 Whereas … = Why Annex IV – CE Marking of Conformity
Annex V – European UDI System
10 Chapters of 123 Articles = What Annex VI – Requirements to be met by Notified Bodies
Annex VII – Classification Criteria
XVI Annexes = How Annex VIII – Conformity Assessment – QMS and Technical Documentation
Annex IX – Conformity Assessment – Type Examination
Annex X – Conformity Assessment – Product Conformity Verification
Annex XI – Procedure for Custom-made Devices
Annex XII – Certificates issued by a Notified Body
Annex XIII – Clinical Evaluation and Post-market clinical follow-up
Annex XIV – Clinical Investigations
Annex XV – Products without an intended medical purpose
Annex XVI – Correlation Table 90/385, 93/42 and Regulation

Wider, clearer scope for EU legislation
• Products manufactured utilising non-viable human tissues or cells, or

their derivatives, that have undergone substantial manipulation
• Reference human tissue donation and procurement legislation
• Certain implantable / invasive products without a medical purpose
• Clarification towards:
• products that contain or consist of viable biological substances
• food covered by Regulation (EC) No 178/2002

Common Specifications
• Extension of legal requirements

• Authored with little input from industry
• Technical and other specification

• Annex XV cosmetic implants
• Reprocessing of single use devices
• Clinical requirements
• and more……
• Will gradually replace MEDDEVs and (selected) Standards

Stronger supervision of notified bodies
• System moves from New Approach to New Legal Framework

• Stronger supervision on Notified Bodies
• Continuation of joint assessment; manual transcribed into NB annex
• Focused clinical scrutiny mechanism on high risk devices
Because of that:
• Stronger supervision by Notified Bodies

More powers for assessment
• Thorough testing and regular checks on manufacturers
• Much stricter acceptance criteria on clinical data and equivalence
• Unannounced factory inspections, including supply chain
• Rotation of notified body staff involved in assessment
• Adoption of common (technical) specifications

Clearer rights & responsibilities
• Clearer responsibilities for manufacturers, importers and distributors
• Also applicable to diagnostic services and internet sales
• Establishing a ‘qualified person’ in manufacturer or authorized rep.
• Relabeling and repackaging clarified
• Liability detailed (manufacturer and authorized rep.)

Obligations Importer & Distributor
• Verify device is CE marked & with Declaration of Conformity & AR designated
• Verify appropriate labelling & IFU, including assignment UDI & registration
EUDAMED
• Appropriate storage or transport conditions
• Inform authority on (suspected) non-compliance
• Keep a register of complaints, non-conforming products, product recalls and
withdrawals
• Provide other economic operators with information to investigate complaints
• Immediately forward information on complaints to manufacturer & AR
• Keep a copy of the declaration of conformity and a copy of the certificate
• Importers shall indicate name & address on the device, its packaging or in a
accompanying document
Liability
• Proportionate to the risk class, type of device and the size of the
enterprise, manufacturers shall have measures in place to provide
sufficient financial coverage in respect of their potential liability
under Directive 85/374/EEC, without prejudice to more protective
measures under national law.
• Liability extended beyond manufacturer and importer to authorized

representative
• Liability for notified bodies
• Liability for sponsor in clinical trial
Reprocessing of Single Use Devices (Recital 38)
• Reprocessing of SUDs only where permitted by national law, and in respect
of requirements laid down in this Regulation.
• Reprocessor should be considered the manufacturer of the device.
• Member States may decide that reprocessing and re-use of SUDs within a
health institution may vary from the obligations of the manufacturer
described in this Regulation.
• In principle this is only permitted when adequate common specifications are in
place and if appropriate national regulations exist and are applied in the
reprocessing of these devices which ensure AT LEAST THE SAME LEVEL OF
SECURITY as in case of the corresponding initial SUDs.
• This also applies if the reprocessing is carried out by an external reprocessor on
behalf of a health institution.

Extended Eudamed database
• Registration of devices and economic operators
• Comprehensive information on products available on the EU market
• Non-confidential data will be publicly available
• Public summary of safety and performance

Better traceability
• Better traceability of medical devices throughout the supply chain
• Swift and effective response to safety problems (e.g. recalls)
• phased introduction of Unique Device Identification (UDI)

• UDI on label, higher packaging,
• UDI on Declaration of Conformity;
• UDI included in implant card;
• UDI central in EUDAMED database

UDI
• UDI on label, higher packaging, DoC; • UDI for now allowed under:
included in implant card, stored by • GSI AISBL
health institutes; • HIBCC
• ICCBBA
• UDI in database before placing
products on the market
• UDI application:
• 1 yr: implantables and class III
• UDI on NB certificates IIb implants and • 3 yr: class IIa and Iib
III • 5 yr: rest
• UDI basis for vigilance reporting

Stricter requirements for clinical evidence
• Stricter requirements for clinical evidence to support assessments
• Interventional clinical performance studies
• Studies with invasive procedures or other risks
• Sponsor introduced
• Database for clinical studies
• Ethical consent detailed
• Continuous performance evaluation integrated in PMS

Hazardous substances
• CMR substances / endocrine disruptors > 0.1% for body contacting

devices and devices in contact with medicines need justification
• Justification details extensified in ER 10.4.2
• Irrespective of existing applicable environmental legislation (REACH)
• Guideline on phthalates
• Guideline on CMR / endocrine disruptors

Updated classification rules
• Keeps four risk classes; AIMD integrated
• Reclassifications:
• AIMD and accessories => III
• Selected orthopaedic implants => III
• Deliberate Nano => III
• Critical care active devices => III
• Ingested, inhaled or administered rectally or vaginally and absorbed

by or dispersed in the human body
Better coordination
• Better coordination between national surveillance authorities, with

the Commission providing scientific, technical and logistic support
• Clinical evaluation / scrutiny
• Market surveillance / vigilance
• Governance system – MedDev Coordination Group (MDCG)
• Encourage device registers

Consultations
An.IX-5.2 Pharmaceuticals An.IX-5.3 Human tissue/cells
• EMA for biotech, recombinant etc. • Consultation with human tissues
and MS for any others and cells competent authority
• 210 days after receipt of valid • 120 days after receipt of valid
documentation: opinion delivered
documentation: opinion delivered
• No way to overrule negative
opinion; any change relating to • No way to overrule negative
pharmaceutical: 60 day review opinion, same change control as
pharmaceuticals
An.IX-5.3 Animal tissue/cells, TSE
susceptible (EC 722/2012) An.IX-5.4 Substances – absorbable as
• Consultation as per current TSE per intended purpose
Regulation (EDQM 4 wks, no EDQM • EMA or MS drug authority, 150 days
12 wks
Scrutiny on implantable class III devices (An.IX-5.1)
• NB clinical evaluation assessment • In case no opinion will be delivered:
report on risk-benefit, consistency 15 days, with motivation of decision;
with intended purpose and PMCF NB proceeds
plan • Opinion from expert panel in 60 days;
• NB report, clinical evaluation docs to NB proceeds
Commission, forwarding to expert • If no opinion in 60 days. NB may
panel proceed
• Optional presentation of NB to expert
panel
• Restriction of purpose to numbers or groups of patients
• Limitation to validity of certificate
• Demand for specific PMCF studies
• Adaptation of Instruction for use
• Other restrictions
Procedure packs – art. 22 So what is different??
• Mix with IVD; mix with non-devices when justified

• Statement on mutual compatibility, packaging with relevant
information, appropriate methods of internal monitoring, verification
and validation
• Sterilization subject to NB conformity assessment
• No additional CE mark, but room for tradename, trademark

Procedure packs – art. 52
• …where the system or procedure pack incorporate devices which do

not bear the CE marking
• …where the chosen combination of devices is not compatible in view
of their original intended purpose
• …where the sterilization has not been carried out in accordance with
the manufacturer's instructions
=> procedure pack shall be treated as a device in its own right; subject
to Article 52. The natural or legal person shall assume the obligations
incumbent on manufacturers.
Key Impact
• Private label route to fund initial developments blocked

• Clinical data requirement pre-market strongly enhanced – higher
upfront investments
• Regulatory requirement much more demanding - higher upfront
investments
• Portfolio rationalization strategies initiated
• New strategies to develop (proof of) concept instead of direct sales
• Ongoing mergers and acquisitions at the top
• Many SME will go out of business or will change company strategy

What to expect?
• NB’s faster to implement changes

• NB’s implement before end of transition
• NB’s too busy for all the work
• Increasing uncertainty on path forward, existence of NB, availability of
services
• Expect bars to be raised and issuance of certificates to be a time-

consuming effort

Resourcing at NBs, authorities, commission
• Some NB fully ready, double procedures, double the staff

• Authorities typically at 0-growth policy
• EUDAMED specs being set, expect 3 years development
• UDI to be specified in details, expect 3 years development
• Harmonization of standards, expect 2-3 years development
• Hospitals not required to use UDI
• CS: priority list in place: UDI, EUDAMED, NBs, annex XV

…..the practical approach
Thank you for your attention
Gert Bos
Executive director & Partner
A global leading medical device consultancy group

Europe - Amsterdam (HQ) | USA - Boston - San Francisco | China – Nanjing
Copyright Qserve Group B.V.

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…..

the practical approach

The upcoming EU MDR

A global leading medical device consultancy group

• Objectives legal revision

Page 2 | Copyright Qserve Group B.V. …..the practical approach

• Consistently high level of health & safety protection for EU citizens

Page 3 | Copyright Qserve Group B.V. …..the practical approach

• Consistently high level of health & safety protection for EU citizens

• Free and fair trade of medical devices throughout the EU

• Adaption to significant technological & scientific progress in the

• Functioning notified bodies

2010 2013 2017-2020

• Updated • Joint inspection • MDR / IVDR

Page 6 | Copyright Qserve Group B.V. …..the practical approach

Page 7 | Copyright Qserve Group B.V. …..the practical approach

• Regulation on NB designation & recommendation on NB work

• Clinical Evaluation Report for all classes of devices

• Own Brand Labeler

Page 10 | Copyright Qserve Group B.V. …..the practical approach

Page 11 | Copyright Qserve Group B.V. …..the practical approach

• Slow process; will take till Q1 2019

Commission (2012) Parliament (2014) Council (2015)

Page 13 | Copyright Qserve Group B.V. …..the practical approach

• Discussion method for negotiations between Council and EP to reach

• No formal rules, it does not exist in the procedures; there is an MoU

• Trilogues, but mainly negotiations between EP and Council; CIE

Page 14 | Copyright Qserve Group B.V. …..the practical approach

Page 15 | Copyright Qserve Group B.V. …..the practical approach

60 pages 175 pages

Key elements of change

Page 16 | Copyright Qserve Group B.V. …..the practical approach

Page 17 | Copyright Qserve Group B.V. …..the practical approach

Page 18 | Copyright Qserve Group B.V. …..the practical approach

• Products manufactured utilising non-viable human tissues or cells, or

• Reference human tissue donation and procurement legislation

• Certain implantable / invasive products without a medical purpose

Page 19 | Copyright Qserve Group B.V. …..the practical approach

• Extension of legal requirements

• Technical and other specification

• Will gradually replace MEDDEVs and (selected) Standards

• System moves from New Approach to New Legal Framework

Page 21 | Copyright Qserve Group B.V. …..the practical approach

• Thorough testing and regular checks on manufacturers

• Much stricter acceptance criteria on clinical data and equivalence

• Unannounced factory inspections, including supply chain

• Rotation of notified body staff involved in assessment

• Adoption of common (technical) specifications

Page 22 | Copyright Qserve Group B.V. …..the practical approach

• Clearer responsibilities for manufacturers, importers and distributors

• Also applicable to diagnostic services and internet sales

• Establishing a ‘qualified person’ in manufacturer or authorized rep.

• Relabeling and repackaging clarified

• Liability detailed (manufacturer and authorized rep.)

Page 23 | Copyright Qserve Group B.V. …..the practical approach

• Liability extended beyond manufacturer and importer to authorized

• Reprocessor should be considered the manufacturer of the device.

Page 26 | Copyright Qserve Group B.V. …..the practical approach

• Registration of devices and economic operators

• Comprehensive information on products available on the EU market

• Non-confidential data will be publicly available

• Public summary of safety and performance

Page 27 | Copyright Qserve Group B.V. …..the practical approach

• Better traceability of medical devices throughout the supply chain