ChallengesofEU-MDR: Transition Periodsand Further ...€¦ · called „sell off provision“ of MDD/AIMDD compliant devices case 1: Placing on the market of a device having an „old“

Challenges of EU-MDR: Transition Periods and Further Provisions ofInterest

Lübeck Summer Academy on Medical Technology; July 4, 2017Dr. Almut Fröhlich, Federal Ministry of Health

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Agenda

• State of play

• Date of application and (a selection of central) transitional provisions

• Options of „placing on the market“ before/after the date of application

• What‘s new? A selection of important innovations/changes of theMDR

• National „implementation“ of the MDR

© Dr. Almut Fröhlich, BMG

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Revision of the EU medical deviceslegislation

• Council Directive 90/385/EEC (active implantable medical devices)• Coucil Directive 93/42/EEC (medical devices)

Regulation on medical devices (MDR)

• Directive 98/79/EC (in vitro diagnostic medical devices)

Regulation on in vitro diagnostic medical devices (IVDR)


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Overview - State of play (MDR)

09/2012:

COM Proposal

04/2014:

EP Amend-ments(342 )

adopted at first

reading

10/2015:

Council General

Approach

05/2016:TriloguePolitical

Agreement(Compro-

mise)

03/2017:Council formal

adoption at first

reading

04/2017:EP formal

adoption at secondreading

5.5.2017publication

in theOfficial

Journal ofthe EU


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State of play in Brussels - Implementation


COM priorities for the next coming

months (13. März 2017, IVD Technical

Group):

• Establishment of the MDCG

• List of codes for the pupose of specifying

the scope of the designation of NBs

• Funding of activities related to

designation and monitoring of NBs

• Detailed arrangements specifying

procedures and reports for the

application for designation and the

assessment of application

• Establishment of EU reference

laboratories

Currently in preparation:

• CS: reprocessing of single-use devices

• CS: Annex XVI- products without an

intended medical purpose

• EUDAMED…..

* Erik Hanson EU KOM 10.11.16, Bonn

Implementing

actsFinal total

...of which

compulsory

MD 32 8

IVD 32 6

Delegated acts Final total...of which

compulsory

MD 11 0

IVD 5 0

Total 80 14

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Entry into force and date of application (Art. 123 para 1 and 2 MDR)

• Entry into force

=> May 25, 2017

• Date of application

=> May 26, 2020 (= 3 years after entry into force)

(IVDR: 5 years, May 26, 2022)

Generally: - MDR and IVDR apply

- „old“ Directives are repealed (Art. 122)


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„Earlier“ date of application(Art. 123 para. 3 a-c, i MDR)

� From November 26, 2017 (6 months after entry into force), para. 3 a,b• Provisions on notified bodies (Art. 35 – Art. 50) • Designation of competent authority(ies) for the implementation of this

regulation (Art. 101) • Establishment of the Medical Device Coordination Group (MDCG)

(Art. 103)

� From May 26, 2018 (12 months after entry into force), para. 3 c• Cooperation of the competent authorities of the MS and COM (e.g. with

regard to uniform application of this regulation) (Art. 102)

� From May 26, 2019 (24 months after entry into force), para.3 i• GS 1, HIBCC und ICCBBA shall be considered to designated issuing

entities regarding UDI (vgl. Art. 120 para. 8)


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„Postponed“ date of application (Art. 123 para. 3 d and e MDR)� At the earliest from May 26, 2020 (or 6 months after the date of

publication of the notice stating that EUDAMED is „fully functional“), Art. 123 para 3 do Numerous provisions listed in Art. 123 para 3d as far as they relate to

EUDAMED and the UDI database

� At the earliest from November 27, 2021 (or 18 months after the date ofpublication of the notice stating that EUDAMED is „fully functional“), Art. 123 para 3 eo Registration of devices in EUDAMED (Art. 29 para 4)o Entering of information regarding certificates by notified bodies in

EUDAMED (Art. 56 para 5)[Please note: Within the „18 months interim period“ = application of „new“ law is optional, see Art. 120 (8)!]


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„Postponed“ date of application (Art. 123 para. 3 f-h MDR)

� From May 26, 2021/2023/2025 (depending on risk), para 3 fUDI labelling duty

� From May 26, 2023/2025/2027 (depending on risk), para 3 gUDI „direct marking“ of reusable devices

� From May 26, 2027 obligatory participation of all MS concerning the„coordinated assessment procedure for clinical investigations“ to beconducted in more than one MS, para 3 h


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Transitional provisions (Art.120):

notified bodies, validity of „old“ certificates, placing on the

marketPrior to the date of application

• Designation and notification of „new“ NBs possible (Art. 120 para. 6)

• „new“ NBs may apply the „new“ confomity assesment procedures andmay issue certificates in accordance with the „new“ MDR (Art. 120 para. 6))

• Placing on the market of „MDR compliant“ devices possible (Art. 120 para. 5)

• Placing on the market of „MDD/AIMDD compliant“ devices according to „old“ law

From the date of application

• „old“ notifications of NBs become void (Art. 120 para 1) (but „old“ NBs shall conitnue to be responsible for the appropriate surveillance in respect of the devices it has certified (Art. 120 para 3))

After the date of application

• „old“ certificates (issued prior to the date of application) remain valid as set out in Art. 120 para 2 –> they become void at the latest May 27, 2024

• Placing on the market of „MDD/AIMDD compliant“ devices on thebasis of an „old“ certificate possible (until May 27, 2024 at the latest, Art. 120 (3))

• Placing on the market of „MDR compliant“ devices according to „new“ law


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Transitional provisions (Art. 120 para 6) –Notified Bodies

Before the date of application (= from November 26, 2017)

possibility of:

• Designation and notification of „new“ NBs

[How will this process be managed/take place? Duration:

approx. 18 months, „bottle neck“?]

• „two in one“ (a notifed body may be an „old“ and a „new“ NB

at a time)

• „new“ NBs may carry out the „new“ conformity assessment

procedures and issue „new“ certificates


| 10.07.2017 | Seite 12© Dr. Almut Fröhlich, BMG

• Generally: Placing on themarket of MDR compliantdevices (+)

• Devices which comply with theMDR (para 5) ?!

• Possible exception: devicessubject to the „scrutinyprocedure“ (para 7)

• pro: provision on „sell off“ (Art. 129 para 4) -> not applicable (?)

BeforeMay 26,

2020

Transitional provisions (Art. 120 para. 5, 7) –Placing on the market of MDR compliantdevices before May 26, 2020

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Transitional provisions (Art. 120 para 3) –Placing on the market after May 26, 2020 on the basis of „old“ certificatesRequirements for the placing on the market by way of derogation from Art. 5 MDR

(until May 27, 2024 at the latest):

• Valid „old“ certificate according to Art. 120 (2)

• Continuous compliance of the device with the „old“ directives

• No significant changes in the design and intended purpose

However, the requirements of the „new“ MDR relating to

• Post-market surveillance

• Market surveillance

• Vigilance

• Registration of economic operators and of devices

shall apply in place of the corresponding requirements of the „old“ directives [exception:

EUDAMED is not fully functional in time]

Moreover, the „old NB“ that has issued the „old“ certificate shall coninue to be responsible

for the appropriate surveillance of the corresponding device(s)


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Transitional provisions (Art. 120 para 4) – so

called „sell off provision“ of MDD/AIMDD compliant

devicescase 1:

Placing on themarket of a device

having an „old“ certificate or of an

MDD/AIMDD compliant class I

device

Date ofapplication

26/05/2020

new case 2: Placing on the

market of a device having an „old“ certificate

!!!…maycontinue to be

made availableon the market

until27/05/2025!!!


Please note: the „sell of provision“ is not supposed to apply to usedor second hand devices

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Different options of „placing on themarket“

Before May 26, 2020

• MDD/AIMDD compliantdevicesvalid „old“ certificate (or classI) (option A)-> „sell off provision“ (+)

• MDR compliant devicesvalid „new“ certificate (orclass I) (option C)-> „sell off provision“ (-)?

From May 26, 2020

• until 05/2024 at the latest: MDD/AIMDD compliantdevicesvalid „old“ certificate (optionB)-> „sell off provision“ (+)-> „new“ law partly applicable(see Art. 120 para. 3)

• MDR compliant devicesvalid „new“ certificate (orclass I) (option D)-> „sell off provision“ (-)


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What is new/different for MFR? (I)

Art. 10 attempts to sum up MFR obligations under the MDR:

Art. 10 (2) system for risk management ! (for the first time described by

law)

Art. 10 (3) clinical evaluation

Art. 10 (4) technical documentation

Art. 10 (6) applicable conformity assessment procedure;

EU declaration of conformity, CE marking of conformity

Art. 10 (7) UDI system, registration of economic operators and

devices

Art. 10 (8) keeping available of relevant documents (10/15 years)


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What’s new different for MFR? (II)

Art. 10 (9) QMS ! (for the first time described by law ISO 13485)

Art. 10 (10) post market surveillance system (implemented and kept

up by the MFR) !

Art. 10 (11) device information (eg: IoU) –> language requirements

Art. 10 (12) obligation to take necessary corrective actions

Art. 10 (13) system for recording and reporting of incidents and field

safety corrective actions

Art. 10 (14) MFR obligations with regard to CA (e.g. providing samples of

the device free of charge)

Art. 10 (15) OEM registration (part of the registration of EO)

Art. 10 (16) liability for defective devices: duty to ensure sufficient

financial coverage


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What is new/different for MFR? (III)

Art. 15 Person responsible for regulatory compliance (� safety

officer for MD and MD consultant according to § 30, 31 MPG)

Art. 18 Implant card and information to be supplied to the patient with

an implanted device (� implant pass according to § 10

MPBetreibVO)


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Art. 10 (3) – Clinical evaluation (Art. 61 / Annex

XIV)

Clinical evaluation (CEv) :

� Essential obligation of the MFR with regard to all devices

� Continuous (quality-assured) process, that needs to

be systematically planned and started at an early stage of

the device‘s lifecycle and that needs to be conducted and

documented throughout the device‘s whole lifetime

(see: clinical evaluation assessment plan /report (CEP/R),

post market clinical follow-up (PMCF) plan/report)

� Consideration of currently available alternative

treatment options

� „equivalence“ decribed by law

� Part of the MFR‘s QMS

� NBs: increased focus on CEv


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Art. 10 (3) – Clinical Evaluation (Art. 61 / Annex XIV)

As a general rule: For class III and implantable devices the CEvhas to be based on clinical investigations (CI) (para 4)Exceptions: � Modifications of an equivalent device already marketed by the

same MFR (para 4)� [equivalent device already marketed by another MFR (but: full

access to the TD on an ongoing basis needed)(para 5)]� Certain implantable devices: Sutures, staples detal fillings etc.

(para 6) � Devices which have been lawfully placed on the market or put

into service in accordance with Dir. 90/385/EEC or 93/42/EEC


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Clinical Investigations (Art. 62ff, Annex XV)� EU – harmonised official approval procedure similar to the German

MPKPV

� Electronic submission of an application to one or more MS via

EUDAMED (data will be partially publicly available)

� Coordinated procedure for clinical investigations conducted in more

than one MS (voluntary for a period of 7 years)

� Publication of the clinical investigation report and its summary

� [legal basis for the development of product specific guidelines on CI

(Art. 105 (e)]

National regulatory leeway e.g. :

� Procedure for the evaluation by an ethics committee

� Additional requirements regarding other (e.g. academic) clinical

investigations


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Art. 10 (4) – Technical Documentation

� Contents: see Annex II, III and XIV� Needs to be continuously updated due to the data

gathered by the MFR‘s post-market surveillancesystem

� + numerous additional reports that need to be updatedon a regularly basis e.g.:

– PMCF (part of theCER)– PSUR (periodic safety update report, Art. 86)– PMS (post market surveillance) Report (Art. 85)– Summary of safety and clinical performance (Art. 32)– Trendreporting (Art. 88)


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Art. 10 (5) - Choosing the „right“ conformityassessment procedure (CAP, Art. 52) – some„specialties“� Class I resuable surgical instruments (Art. 52 para 7): Involvement of a NB with

regard to aspects relating to the reuse of a device (cleaning, disinfection, sterilization,

maintenance, functional testing and the related instructions for use)

� Class II b implantable devices (Art. 52 para 4 second sentence): QMS assessment +

assessment of the TD for every device

� Class II b active devices, intended to administer and/or remove a medicinal

product, may be subject to the „scrutiny procedure“ (Art. 54) (thus: invovlement of a

NB for every device).

� Specific additional procedures for e.g.:

� Devices that are composed of substances or of combinations of substances ….. that

are absorbed by or locally dispersed in the human body (Art. 52 para 11)

� „Tissue and cells“ devices (Art. 52 para 10)…


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New classification rules (examples) (Annex VIII)

� Definition of „implantable device“ has changed:� Dental fillings, dental braces, thooth crowns -> implantable device (+)� [“(5) ‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended

� – to be totally introduced into the human body or� – to replace an epithelial surface or the surface of the eye,� by clinical intervention and which is intended to remain in place after the procedure.� Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the

procedure for at least 30 days shall also be considered an implantable device.”]

� rule 11: „independent“ software -> class I to III� rule 14: Devices incorporating a substance (class III) -> deletion of „that is liable to

act on the human body“ may lead to an extension of the scope. � rule 19: devices incorporating or consisting of nanomaterial depending on the

potential for internal exposure -> class IIa to III� rule 21: Devices that are composed of substances or of combinations of

substances ….. that are absorbed by or locally dispersed in the human body -> class IIa to III (+ specific additional CAPs)


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„Scrutiny procedure“ for high risk devices(Art. 54 MDR and Annex IX Chapter II 5.1)� Additional assessment procedure – primarily focused on the clinical

evaluation - by an expert panel (ExP) for certain high risk devices

� Applicable:

– Implantable class III devices– Class II b active devices intended to administer and/or remove a medicinal

product (e.g. insulin pump)

� Unless:

– Renewal of a MDR certificate– Certain modifications of a device already marketed by the same MFR– NB confirms compliance with the relevant common specifications for clinical

evaluation of that kind of device

� NB: notification of its decision on applicability to CA, national authorityresponsible for NBs and COM via EUDAMED

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„Scrutiny procedure“ for high risk devices(Art. 54 MDR and Annex IX Chapter II 5.1)

In case a „scrutiny procedure“ is required:

NB: transmits its

Clinical

Evaluation

Assessment

Report (CEAR) +

MFR’s clinical

evaluation

documentation

to COM

COM: transmits the

documents to the

relevant expert

panel (ExP)

ExP:

(within 21days of receipt) decision to

provide a scientific opinion or not

(under the supervision of the

commission)

Criteria:

• Novelty

• Significant adverse change in the

risk-benefit-profile

• signifiicantly increased rate of

serious incidents reported

Notification of its decision to COM via

EUDAMED

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„Scrutiny procedure“ for high risk devices

(Art. 54 MDR and Annex IX Chapter II 5.1)

ExP:

informs the NB andCOM about itsdecision + reasons

NB:

may proceed withthe certificationprocedure

ExP:

Negative decision

=

No scientificopinion

ExP:

(within 60 days of receipt) provides scientific opinion(EUDAMED)

(if not: NB may proceed withthe certification procedure)

NB:

- due consideration to ExPopinion

- full justification, if it doesnot follow ExP advice (publiclyavailable via EUDAMED)

ExP:

Positive decision

=

Scientific opinion

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UDI - System (Unique Device IdentificationSystem, Art. 27)

� Production of an UDI [UDI DI + PI]

(Assignment; issuing entities GS1, HIBBIC,

ISBNT)

� Placing of the UDI on the label (Labelling)

� Storage of the UDI by economic operators,

health institutions and healthcare professionals

� Establishment of an UDI database

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Art. 10 (7) – Registration of devices and economic operators –Future Eudamed (Art. 33 Abs. 2)

Electronic system on registration of economic operators(MFR, AR, importer)

(Single Registration Number (SRN) + validation by CA) Datenelemente (Annex VI, Part A, Section 1)

UDI database (Basic UDI DI) Device identifiation (UDI-DIs)

Data elements (Annex VI Part B)

ElectronicSystem

on NBs andCertificates

Certificates issued&

Information on Certificates (status)

ElectronicSystem on

Vigilance andPost-marketSurveillance

Serious incidents&

Field safety Corrective actions

&

Field safety notices&

PSUR’s …

ElectronicSystem on

MarketSurveillance

Results of

surveillance activities….

ElectronicSystem on

ClinicalInvestigations

Singleidentifcation

number&

ClinicalInvestigation

Report etc

EUDAMEDEuropean Databank on Medical Devices

Electronic Systemfor

Registration ofdevices

(Annex V IPart A

Section 2)

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Art. 10 (7) - New Registration Processes – How to get a SRN ?Economic Operators (Art. 31)

Electronic system on Registration

MFR/AR/Importer electronic application (information according to

Annex V Part A section 1)

Verification by the Competent Authority

EUDAMED creates a Single Registration Number (SRN) which will be used in future for identifying the MFR/AR/Importer (and all linked information)

SRN

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UDI databaseDevice Identifier

data elements (Annex VI Part-B)

Art. 10 (7) New Registration Processes –How to register a device in the UDI database? (Art. 29, e.g. Class I)

MFR or AR provides BASIC-UDI-DI related data (Annex VI Part B)

SRN

Class I device

MFR/ARassigns an

Basic UDI-DI

UDIIssuingEntities

BASIC-UDI-DI

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Art. 10 (16) - (obligatory) Liability coveragefor manufacturers

� Defective devices -> damages

� Liability under Union law (Directive 85/374/EEC – product liability) -> national law

� MFR shall (obligatory):� in a manner that is proportionate to the risk class, type of device

and the size of the enterprise� have measures in place (e.g.insurance, bank guarantee, ….?)� to provide sufficient financial coverage in respect of their potential

liability under Directive 85/374/EEC

� „more protective measures“ under national law possible

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National „implementation“: What needs to bedone?� Member States:

� MDR is directly applicable and takes precedence over national law („This

Regulation shall be binding in its entirety and directly applicable in all

Member States“) -> no „formal“ implementation necessary

� but: MDR contains mandates (mandatory „has to“, optional „may“) for

national legislative action

� but: MDR empowers COM with regard to numerous delegated andimplementing acts (participation MS)

� In general: identical or contradictory national law is not allowed

therefore: Adjustment/repeal of the national law (MPG, ordinances etc)

from 2020

� Identification and evaluation of issues with a need for interpretative guidance!

� Economic Operators: � Start preparing!!!


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National „implementation taskforce“Establishment of a national coordination and working group for theimplementation of the MDR/IVDR (= Nationalen Arbeitskreises zur

Implementierung der MDR/IVDR, short: NAKI)

Kick-off event: February 13, 2017

Members of the NAKI:

• Federal Ministries: BMG, BMWi, BMBF, BMVg

• Higher federal authorities: BfArM, PEI, DIMDI

• 8 highest state authorities und ZLG

• 9 manufacturers associations

• IG-NB

• Delegations from trade (PHAGRO)

• Deutsche Krankenhausgesellschaft (DKG)

• GKV-Spitzenverband

• Aktionsbündnis für Patientensicherheit (APS)

• Arbeitsgemeinschaft der wissenschaftlichen medizinischen

Fachgesellschaften (AWMF)


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National „implementation taskforce“

Tasks of the NAKI (coordination body):

• Identification of issues regarding the

interpretation/implementation of the MDR that need

clarification/guidance

• Interlocking of national and European „implementation“

activites

• Proposals for the appointment to EU-boards (MDCG etc.)

• Development of a national infrastructure for the recruitment of

(clinical) experts for the „expert panels“ (Art. 106 MDR)

• Definition of tasks for the subgroups

counselling function


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National „implementation taskforce“

Sub-groups of the NAKI:1. Transitional provisions (chaired by BMG) �2. Notified bodies (chaired by ZLG) �3. MFR obligations (chaired by BMG) �

4. Marketsurveillance (chaired by a highest state authority)5. Classification/borderline and vigilance (chaired by BfArM) �6. Clinical evaluation and clinical investigation (chaired by BMG) �7. Reprocessing (chaired by BMG) �

In case of need:8. IVD specific issues9. MD composed of substances etc.

continuous process


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!! Thank you !!

?? Any questions ??


Kontakt

Bundesministerium für GesundheitReferat 119Rochusstr. 153123 [email protected]

AnsprechpartnerDr. Almut Frö[email protected]. +49 30 18 441 4548

Documents

ChallengesofEU-MDR: Transition Periodsand Further ...€¦ · called „sell off provision“ of MDD/AIMDD compliant devices case 1: Placing on the market of a device having an „old“