Shelley Tang

1
Proposed Regulatory Framework for IVDs -
Conformity Assessment Procedures

• Shelley Tang
• Medical Devices Assessment Section
• Office of Devices, Blood and Tissues

2
Conformity Assessment Procedures

• Obligations on manufacturers
• Purpose
• to demonstrate compliance with the Essential
  Principles
• quality, safety and performance

3
Conformity Assessment Procedures

• Amount of information to be submitted increases
  with risk class
• Agency audit of all Australian/New Zealand and
  some overseas manufacturers (not Class 1)
• Use of standards
• the Agency will designate (gazette) specific
  standards which manufacturers can choose to use
  in complying with one or more specific EPs

4
Conformity Assessment Procedures

• Elements
• Quality Management System requirements
• Design Dossier for Class IV
• Performance Testing
• Technical Documentation
• Declaration of Conformity
• Post market monitoring
• Reporting requirements

5
Conformity Assessment Procedures

• Quality Management Systems
• cover manufacture of the IVDs
• ensures that product manufactured meets design
  specifications
• compliance with ISO 134852003 required
• assessment (through on-site audit) required
• may be by the Agency
• for overseas manufacturers an assessment by
  another organisation recognised by the Agency
• Regular audits required

6
Conformity Assessment Procedures

• Technical Documentation
• description of the product
• manufacturing process and controls
• design inputs
• testing
• risk analysis
• clinical data (performance evaluation data)
• stability studies
• labelling, instructions for use

7
Conformity Assessment Procedures

• Technical Documentation
• held in Technical File for product
• collated in form of Design Dossier for Class IV
  products
• must be submitted for assessment as required

8
Conformity Assessment Procedures

• Declaration of Conformity
• Manufacturers declaration that
• conformity assessment procedures have been
  applied to the manufacture
• IVD(s) comply with the relevant Essential
  Principles
• all other regulatory requirements met
• must specify the IVDs to which it applies

9
Conformity Assessment Procedures

• Post-market monitoring
• manufacturer must have procedures in place to
  gather information on quality and performance in
  the post-market phase
• must actively seek information
• must feed that information back to consider
  impacts on design
• must take corrective action on poor
  performance/quality

10
Post-Market Monitoring

• Agency surveillance
• investigation
• site inspection
• lab analysis

Manufacturer/ sponsor market surveillance
Mandatory Incident Reporting
Mandatory incident reporting to Agency
11
Conformity Assessment Procedures

• Class 1
• manufacturer self certifies compliance to EPs
  declaration of conformity
• elements of a QMS
• QMS not assessed
• must hold technical documentation
• subject to post-market audit
• normally no Agency involvement in pre-market
  assessment

12
Conformity Assessment Procedures

• Class 2
• require a QMS, and assessment of the QMS
• technical documentation to be held, and checked
  in the context of on-site audit
• manufacturer signs DOC after issue of
  certification
• must have post-market surveillance in place
• must have procedures to notify the Agency of
  adverse events

13
Conformity Assessment Procedures

• Class 3
• require a QMS, and assessment of the QMS
• Technical File to be submitted for assessment if
  required (will be assessed for a subset of Class
  IIIs)
• signs DOC after issue of certification
• must have post-market surveillance in place
• must have procedures to notify the Agency of
  adverse events

14
Conformity Assessment Procedures

• Class 4
• require a QMS, and assessment of the QMS
• Design Dossier to be submitted for assessment
• performance testing by Agency
• signs DOC after issue of certification
• must have post-market surveillance in place
• must have procedures to notify the Agency of
  adverse events

15
Performance testing

• Currently conducted by National Serology
  Reference Laboratory (NRL) ESR will be involved
• Stage 1 - performance data
• NRL evaluates clinical trial data
• Stage 2 - preliminary trials at NRL
• product tested using selected panels of
  characterised samples
• Stage 3 - evaluation of performance
• product tested either at the NRL or at a
  designated laboratory

16
Certification

• Conformity Assessment Certificate issued by the
  Agency required for
• All Class 4 IVDs
• IVDs manufactured in Australia or New Zealand
• Any others for which appropriate overseas
  certification does not exist

17
Certification

• Application Audits will be conducted on IVDs for
• blood and tissue screening in selected
  populations eg CMV testing for neonates, Parvo B
  19
• detecting the presence of a transmissible agent
  that causes a serious risk of propagation in
  the Australian/New Zealand population eg SARS.
• The Agency will also retain the capacity to
  undertake a random application audit on any Class
  1, 2 or 3 IVD.

18
Application Audit

• Desk Top Review
• Intention is to ensure that an appropriate CAP
  has been applied
• calls in the documentation generated by the CE
  Marking process in Europe, but
• needs to support the Declaration of Conformity
  to Agency requirements
• ensures that the links between the manufacturer
  and sponsor are in place

19
Certification

• Appropriate overseas certification is
• EC certification issued under the European IVD
  Directive
• In the absence of a CE certificate, certification
  to ISO 134852003 issued by a European Notified
  Body will be accepted
• This approach will be used in the interim until
  IVDs are included in the MRA

20
Questions? Comments!