notified body perspectives on key elements of the · pdf file4 medical device regulation (mdr)...

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Notified Body Perspectives on Key Elements of the MDR

Sheila Walsh, Certification Lead, BSI

27th October 2016

Copyright © 2016 BSI. All rights reserved.

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Agenda

• How we got to this Point

• Transition Period

• Legacy Technical Files

• Labelling

• Clinical Evaluation Consultation (Scrutiny Procedure)

• Changing Notified Body Landscape

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How we got to this Point…

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Medical Device Regulation (MDR)

2008

2012

2014 Q2

2015 Q3

2015 Q4

Early 2017

EU Commission launches consultation on MD framework

EU Commission publishes proposal for new MD Regulation

EU Parliament adopts position on MDR

EU Council adopts position on proposed Regulation

Trilogues between Commission, Parliament and Council start

Expected publication of the adopted MDR in EUOJ

PIP Scandal

1st Draft MDR

Current Draft

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MDR Transition Period – Article 97

1. This Regulation shall enter into force on the twentieth day after its publication in the Official Journal of the European Union.

2. It shall apply from [three years after entry into force].

2017

Q1

• MDR enters into force

• 3 Year Transition Period

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Transition Period

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Article 94 – Transitional provisions Point 2 - 1

Year 6 Year 5 Year 4 Year 3 Year 2 Year 1

OJ Entry into Force

Adoption

Date of Application

Year -1

Certificates under 90/385/EEC and 93/42/EEC before MDR Adoption: 5yrs

Certificates under 90/385/EEC and 93/42/EEC before MDR Adoption: 5yrs

• Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to the entry into force of this Regulation shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex 4 of Directive 90/385/EEC or Annex IV of Directive 93/42/EEC which shall become void at the latest two years after the date of application of this Regulation. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC after the entry into force of this Regulation shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its delivery. They shall however become void at the latest two five years after the date of application of this Regulation.

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• Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to the entry into force of this Regulation shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex 4 of Directive 90/385/EEC or Annex IV of Directive 93/42/EEC which shall become void at the latest two years after the date of application of this Regulation. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC after the entry into force of this Regulation shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its delivery. They shall however become void at the latest two five years after the date of application of this Regulation.


OJ Entry into Force

Adoption

Date of Application

Year -1

*Batch Verification Certificates before MDR Adoption: 2yrs after Application

Batch Verification Certificates before MDR Adoption: 2yrs after Application

* Batch verification certificates have no expiry date

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• Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC prior to the entry into force of this Regulation shall remain valid until the end of the period indicated on the certificate, except for certificates issued in accordance with Annex 4 of Directive 90/385/EEC or Annex IV of Directive 93/42/EEC which shall become void at the latest two years after the date of application of this Regulation. Certificates issued by notified bodies in accordance with Directives 90/385/EEC and 93/42/EEC after the entry into force of this Regulation shall remain valid until the end of the period indicated on the certificate, which shall not exceed five years from its delivery. They shall however become void at the latest four years after the date of application of this Regulation.



OJ Entry into Force

Adoption

Date of Application

Year -1

MDD/AIMD Certificates after MDR Adoption: Full 5yrs

MDD/AIMD Certificates after MDR Adoption: Max 4yrs

Year 7 Year 8

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Article 94 – Transitional provisions Points 3, 3a and 4

• By way of derogation from Directives 90/385/EEC and 93/42/EEC, devices which comply with this Regulation may be placed on the market before its date of application.

• Devices which were lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to the date referred to in Article 97(2) may continue to be made available until 5 years after that date.

• By way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified before its date of application. Notified bodies which are designated and notified in accordance with this Regulation may apply the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation before its date of application.

MDR Certificates after Adoption before Application: 5yrs

MDR Certificates after Adoption before Application: 5yrs


OJ Entry into Force

Adoption

Date of Application

Year -1 Year 7 Year 8

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Article 94 – Transitional provisions Points 3, 3a and 4

• By way of derogation from Directives 90/385/EEC and 93/42/EEC, devices which comply with this Regulation may be placed on the market before its date of application.

• Devices which were lawfully placed on the market pursuant to Directives 90/385/EEC and 93/42/EEC prior to the date referred to in Article 97(2) *date of application may continue to be made available until five years after that date.

y way of derogation from Directives 90/385/EEC and 93/42/EEC, conformity assessment bodies which comply with this Regulation may be designated and notified before its date of application. Notified bodies which are designated and notified in accordance with this Regulation may apply the conformity assessment procedures laid down in this Regulation and issue certificates in accordance with this Regulation before its date of application.

MD/AIMD prior to Application 5yrs


OJ Entry into Force

Adoption

Date of Application

Year -1 Year 7 Year 8

MD/AIMD prior to Application 5yrs

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NB Designation Process

• Notified Body applies for Designation: Competent Authority (CA) and EU Commission Reviews application

• Notified Body undergoes audit by Join Audit Team (JAT)

• NB responds to any NCs

• JAT closes NCs provides final report to EU Commission

• EU Commission submits opinion to Medical Device Coordination Group (MDCG)

• MDCG reviews application and assessment report

• Makes recommendation to CA for draft Designation

• CA reviews recommendation

• Designation of NB under MDR

• CA posts notification on EUDAMED

• EU Commission posts designation on NANDO

Total Time ~ 12 - 18 months

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Legacy Technical Files

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True or False?

Existing devices will be automatically grandfathered into the new Regulation without need for clinical investigation or further documentation.

True False

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True or False?

Existing devices will be automatically grandfathered into the new Regulation without need for clinical investigation or further documentation.

True False

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Legacy Technical Files

• It seems to be a common misunderstanding that the entry into force of the new regulations will not affect devices already on the market.

• The draft of the new Regulation DOES NOT include a “grandfather” clause for medical devices that are already placed on the market.

• Devices which are currently on the market and considered to be compliant and safe will be subject to a new conformity assessment, under the MDR.

• As there are new requirements within the MDR, particularly with respect to Clinical Data not all certificates will transition smoothly from the MDD to the MDR.

• Once MDD certificates expire, MDR certificates are required to continue marketing the devices.

• Where there are gaps in certification, manufacturers may need to take devices off the market until all additional MDR requirements can be met and MDR certificates issued.

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Conformity Assessment to the MDR

EC MDR QA Certificate

• Upgrade QMS Conformity Assessment to MDR • Sample Technical Files (IIa & IIb) • Issue MDR QA Certificate • MDD QA Certificate may still be required to

support MDD Design Dossiers.

EC MDR Design Examination Certificate

• Submission of MDR Design Dossier (based on MDD DD) • New submission for devices upclassified to Class III • Include Renewal Data • DD Review against MDR requirements • Issue EC MDR Design Examination Certificate (post

MDR QA certificate)

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Actions Required

• Manufacturers will need to carefully plan for the transitioning of their existing devices to new certificates.

• Manufacturers need to identify what additional clinical data will be required for their medical devices.

• For now and during the transitional period, data can be obtained through PMS and PMCF studies.

• Manufacturers need to start implementing PMS measures to generate the required additional data now.

• Work closely with your Notified Body to plan ahead and make the transition process as smooth as possible.

• Worst case scenario for both parties is gaps in certification resulting in devices having to be taken off the market until a new certificate can be obtained.

• Under the MDR Clinical Data will be via a Clinical Investigation.

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Labelling

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Annex I – Safety & Performance Requirements (SPR’s)

14. Electronic programmable systems

15. Active devices and devices connected to them (ISO 60601)

16. Protection against mechanical and thermal risks

17. Protection against the risks posed to the patient or user by supplied energy or substances

18. Protection against the risks posed by medical devices intended by the manufacturer for use by lay

persons

19. Information Supplied by the Manufacturer + Implant Card (Article 16) + Promotional

Material CE Marked (Article 18) + UDI (Article 24)

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Annex I – Safety & Performance Requirements

• SPR# 19.2. Information on the label

• The label shall bear the following particulars:

• Many new requirements …

• (h) the unique device identification (UDI) carrier according to Article 24 and Annex V Part C.

• (fa) SPR #7.4.5 – list of carcinogenic, mutagenic, toxic to reproduction, having endocrine disrupting properties >0.1% weight by weight

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Article 24

4. The UDI carrier shall be placed on the label of the device and on all higher levels of packaging. Higher levels of packaging do not include shipping containers.

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Article 24 – UDI

*not commercially available on its own

*if significant space constraint on the unit of use package the UDI may be placed on the next higher package level

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Article 24


• The UDI shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 61.

• The Basic UDI device identifier (‘Basic UDI-DI’ as defined in Annex V Part C) of the device shall appear on the EU declaration of conformity referred to in Article 17.

• The manufacturer shall keep up-to-date a list of all applied UDI as part of the technical documentation referred to in Annex II.

Numeric description of device

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Article 24





Annex III

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Article 24 The technical documentation and, if applicable, the

summary thereof to be drawn up by the manufacturer shall

be presented in a clear, organised, readily searchable and

unequivocal way and shall include:

1. DEVICE DESCRIPTION, SPECIFICATION, VARIANTS

& ACCESSORIES

• Device description and specification + UDI

• Reference to previous / similar generations of

the device

2. INFORMATION SUPPLIED BY THE MANUFACTURER

3. DESIGN AND MANUFACTURING INFORMATION

4. GENERAL SAFETY AND PERFORMANCE

REQUIREMENTS

5. RISK/BENEFIT ANALYSIS AND RISK MANAGEMENT

6. PRODUCT VERIFICATION AND VALIDATION

• Pre-clinical and clinical data

• Additional information in specific cases





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Article 16 – Implant Card

The manufacturer of an implantable device shall provide together with the device the following:

device name

serial number

batch code or lot number

Unique Device Identification

device model

manufacturer name, address and URL of the website

any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions;

any information about the expected lifetime of the device and any necessary follow-up;

any other information to assure a safe use of the device by the patient

including the information in Annex I, Section 19.3 – Instructions for Use

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Clinical Evaluation Consultation

(Scrutiny Procedure)

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Class III Implantable Device & Class IIb Active Devices intended to administer medicinal products* (including those with medicinal substances, human tissues or animal tissues)

Annex IX

Type Examination

Declaration of Conformity (Annex III) & CE Marking (Annex IV)

Annex VIII

QMS

Annex VIII

Technical Documentation

Article 42 Point 2

Annex X – Part A

Production Quality Assurance

Annex X – Part B

Product Verification

Consultation – 2001/83/EC, EC/726/2004, 2004/23/EC, EU/722/2012

Consultation Procedure – Annex VIII or Annex IX Section 6.0

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Annex VIII – Clause 6 / Annex IX – Clause 6 Im

pla

nta

ble

Cla

ss I

II &

Cla

ss I

Ib A

ctiv

e –

Adm

inis

ter

Medic

ines

Article 44: • Manufacturer’s

Clinical Evaluation

• NB Clinical Evaluation Report

• PMCF Plan • IFU • Summary of

Safety and Performance

EU

Com

mis

sion

NB F

urt

her

Revie

w

Com

ple

te C

onfo

rmity

Ass

ess

ment

Notified Body

Review

21 days

39 days

Notified Body

Review

• Benefit:Risk Determination

• Consistency with indications

• PMCF Plan

No ‘sc

ientific

opin

ion’

Notified Body Certificate

• Restrict indications • Limit duration of

certificate • Undertake specific

PMCF studies • Adapt IFU or

Summary of Safety and Clinical Performance

• Impose other restrictions

• Duly justify if advice not followed

Notified Body Certificate

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Changing Notified Body

Landscape

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Less Medical Device Notified Bodies • European Commission’s Joint Immediate Action Plan was launched in 2012 to restore confidence in the

existing MDD legislation post PIP.

• Actions included a reassessment of the qualifications and scope of activities of their Notified Bodies.

• Joint audits of Notified Bodies were conducted by audit teams from several Member States and the Commission.

• Various issues were identified during these assessments which led to de-designation, scope restrictions and some Notified Bodies stepping down or being acquired.

• As a result there has been a rapid decrease in the number of Notified Bodies actively providing Medical Device CE marking services over the last 3 years.

• As the MDR raises the bar further with respect to requirements for the accreditation and supervision of notified bodies, this downward trend is likely to continue.

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Notified Body Challenges • Fewer Notified Bodies are available to assess new products and renew certificates needed by

companies to operate.

• Existing bodies are finding it difficult to find qualified personnel to help with the extra workload.

• Where recruitment is successful, the training process takes significant time and places pressure on existing resources.

• This impacts on capacity and ultimately leads to delays in the approval of new products, renewals and changes to existing products.

• The MDR introduces more complex conformity assessment procedures and more stringent clinical data requirements, which will mean even more work and longer review time-lines.

• UDI on certificates will mean that certificates will require repeated reissue (lots of things trigger UDI changes) impacting on NB resources.

• Designation to the MDR will probably be 12 – 18 month into the Transition Period meaning that the first MDR certificates to be issued will be towards the end of the Transition timeline, which will put pressure on our capacity to issue MDR certificates.

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Solutions

• Act now

• Start Planning

• Hire competent people

• Train existing staff

• Start putting new systems in place to deal with the new requirements

• Lodge application for designation as soon as possible.

• Work closely with manufacturers to try and keep moving through the process and avoid bottlenecks if at all possible.

• Apply the new rules but be as pragmatic as we possibly can particularly with devices which have been compliant and safe for many years.

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