Session B2: Medical Devices Accurate manufacturers evidence

Session B2: Medical Devices Accurate Manufacturer Evidence

Carol Hanrahan Departmental Officer Devices Application and Verification Section Office of Devices Authorisation Sponsor Training Day - 9 September 2014

Overview

• Manufacturer Evidence

• Minimum conformity assessment procedures

• Manufacturer Evidence via electronic Business Services (eBS)

• New Manufacturer Evidence

• Variation to Manufacturer Evidence

• Common issues with submitting Manufacturer Evidence

Session B2: Medical Devices – Accurate Manufacturers Evidence

Manufacturer Evidence Manufacturer Evidence (ME) constitutes a certificate that

demonstrates that appropriate conformity assessment procedures have been applied by the manufacturer to a kind(s)

of medical device(s). • Acceptance of ME by the TGA is the first step before applying

for a medical device to be included in the Australian Register of Therapeutic Goods (ARTG).

• ME is submitted via electronic Business Services (eBS) to obtain a Manufacturer Evidence identifier. The ME identifier is a number used when submitting an application for inclusion of a medical device in the ARTG.


Manufacturer Evidence (cont.) • Application for a medical device to be included in the

ARTG must be made in accordance with a form approved by the Secretary.

• The Manufacturer Evidence identifier is to be entered on the form in electronic Business Services (eBS):


Evidence of conformity assessment procedures The TGA accepts the following certificates as evidence of the application of an appropriate conformity assessment procedure: • Conformity Assessment Certificate issued by the TGA.

• MRA (Mutual Recognition Agreement) Certificates issued by an EU Notified Body in accordance with Australian regulatory requirements

– Australia-EC MRA

– Australia-EFTA MRA

• EC certificate issued by an EU Notified Body in accordance with EU regulatory requirements and Directives.

Australia has signed a Mutual Recognition Agreement (MRA) with the European Community (EC)

Australia has signed a European Free Trade Agreement (EFTA) with the Republic of Iceland, the Principality of Liechtenstein and the Kingdom of Norway


Minimum Conformity Assessment Procedures • A medical device requires the application of appropriate

conformity assessment procedures relevant to its classification

• Part 3, Division 3.2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) sets out the minimum conformity assessment procedures that must be applied to different classes of medical devices

• Schedule 3 of the Regulations sets out the conformity assessment procedures

• Australian Vs European


Classification & Conformity Assessment Procedures Required (1)

* devices other than devices to be used for a special purpose (medical device used for a special purpose means a medical device to which regulation 3.10 applies; Part 7 of Schedule 3 provides procedures that must be applied to medical devices used for a special purpose) ** CAC – conformity assessment certificate (conformity assessment certificate means a certificate issued under section 41EE of the Act, this means certificate issued by the TGA) or Certificate issued under MRA in accordance with the relevant Part of Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002

Medical device (non-IVD) – Class*

Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002

EC Certificate issued under MDD 93/42/EEC

(Declaration must be made in accordance with Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002)

Provided under TG (MD) Regulations

Class I Declaration of Conformity - Part 6 N/A Regulation 3.9(1)

Class Is Declaration of Conformity - Part 6 plus:

• CAC** Production Quality Assurance - Part 4

• Annex II.3 OR • Annex V (‘sterility aspects’ or equivalent

wording)

Regulation 3.9(2)

Class Im

Declaration of Conformity - Part 6 plus CAC issued under either:

• Verification - Part 3 or

• Production Quality Assurance - Part 4 or

• Product Quality Assurance - Part 5

• Annex II.3 or • Annex IV ( specific batches are included on

the certificate) or • Annex V or • Annex VI (‘metrology aspects’ or equivalent

wording)

Regulation 3.9(3)

Class IIa

CAC Full Quality Assurance - Part 1 (excluding clause 1.6 Design Examination) or

Declaration of Conformity - Part 6 plus CAC issued under either:

• Verification - Part 3 (for non-sterile devices) or


• Product Quality Assurance – Part 5 (for non-sterile devices)

• Annex II.3 or • Annex IV (for non-sterile devices where

specific batches are included on the certificate) or

• Annex V or • Annex VI (for non-sterile devices)

Regulation 3.8


Classification & Conformity Assessment Procedures Required (2) Medical device (non-IVD) – Class*

Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002

EC Certificate issued under MDD 93/42/EEC

(Declaration must be made in accordance with Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002)

Provided under TG (MD) Regulations

Class IIb

CAC Full Quality Assurance - Part 1 (excluding clause 1.6

Design Examination) or

CAC Type Examination - Part 2 plus CAC issued under either:



• Product Quality Assurance – Part 5 (for non-sterile devices)

• Annex II.3 or • Annex III plus either: − Annex IV (for non-sterile devices where

specific batches are included on the certificate) or

− Annex V or

− Annex VI (for non-sterile devices)

Regulation 3.7

Class III

CAC Full Quality Assurance - Part 1 (including clause 1.6 Design Examination) or

CAC Type Examination - Part 2 plus CAC issued under either:


• Production Quality Assurance - Part 4

• Annex II.3+II.4 or • Annex III plus either: − Annex IV (for non-sterile devices where

specific batches are included on the certificate); or

− Annex V Regulation 3.6

AIMD 90/385/EEC (AIMDD)


Manufacturer Evidence via eBS • ME Applications:

1. New Manufacturer Evidence identifier; or

2. Variation to existing Manufacturer Evidence identifier.


New Manufacturer Evidence Identifier 1. Issued by a recognised Notified Body

(name & Notified Body number)

2. Manufacturer’s name and address

3. Certificate number

4. Annex route & relevant Directive

5. Scope of certificate is listed

6. Issue date / Re-issue date / Expiry date

7. Signature

Assessment of EC Certificate:


Attachment/Annex to EC Certificate checklist:

1. Notified Body (name & Notified Body number) is the same as EC Certificate

2. Attachment/Annex lists the relevant EC Certificate number it relates to

3. Re-certification date

4. Scope of certificate is listed

5. Signature


Variation to Manufacturer Evidence Identifier • Applications to vary Manufacturer Evidence are

submitted via the TGA’s eBS website • Variation to Manufacturer Evidence is required when

there have been changes to certificates, including: - Certificate has expired and re-issued - Certificate number has changed - Scope of the certificate has changed - Conformity assessment procedure changed including

manufacturer’s details - Manufacturer has changed Notified Body


Acceptance of Manufacturer Evidence • The Sponsor will receive notification in eBS when their

Manufacturer Evidence (new and variation) application is accepted

• One Manufacturer Evidence can contain one certificate, the scope of which covers multiple kinds of devices

• Sponsors do not need to include the same certificate under different Manufacturer Evidence identifier numbers for an application for ARTG inclusion for all kinds of devices specified under the scope of that certificate

• The Manufacturer Evidence Identifier is used when submitting an application for inclusion of a medical device in the ARTG. Session B2: Medical Devices – Accurate Manufacturers Evidence

Common issues with submitting Manufacturer Evidence • Two or more Certificates attached to Manufacturer Evidence

– Manufacturer Evidence generally only contains one certificate

• Declaration of Conformity (DoC) made under European Regulations attached together with Certificate or provided instead of Certificate – The TGA is unable to accept Manufacturer Evidence as the DoC must

be made in accordance with the Regulations (not European Directive)

• Incomplete Certificate (e.g. page numbers on certificate indicate more pages than have been provided) – These addendum/annex/pages form an integral part of the certificate

as they may provide further information contained in the certificate


Common issues (cont.) • Change of Manufacturer’s name and/or site address

– No Supporting evidence from the notified body that issued the amended certificate has been attached to the application along with the updated certificate to determine if the certificate is issued to the same manufacturer.

• Multiple documentation attached • Certificates that are not accepted as evidence of

appropriate conformity assessment procedures – ISO certificates, FDA , EN – Declaration of Conformity and Design Examination Certificates

should not be provided as Manufacturer Evidence (except Declaration made in accordance with Clause 7.5 of Schedule 3 of the Regulations)


Common issues (cont.) • The Certificate provided is not in English

– All documents must be provided in English; proper translation done by an accredited translator is acceptable

• Information in the application does not reflect the Certificate – The following details are the most common errors that result in

submission being rejected: Incorrect annex route Incorrect directive Incorrect notified body number selected on application Sponsor states ‘scope has not changed’ but it has been found

that the scope of Certificate has changed • The Certificate has been altered including highlighting, white-

out or adding additional products – The Certificate needs to be in its original state and all details need to

be shown on the certificate. A watermark is acceptable. Session B2: Medical Devices – Accurate Manufacturers Evidence

Brought to you by:

Accurate Manufacturers Evidence

Milica Talic Regulatory Affairs Director

Cook Medical Australia &

Sharyn Roberts Regulatory Affairs Supervisor

Medtronic Australasia

When is Manufacturers Evidence required and when is it not required?

Manufacturers Evidence is required for Medical Device Applications for: • Class 1 Sterile • Class I Measuring • Class IIa • Class IIb • Class III • AIMD Manufacturers Evidence is not required for: • Class I • Export Only

Examples of Types of Certificates and associated Manufacturers Evidence

• TGA CA Certificate:

Note: All pages of the supporting documentation must be submitted with the Manufacturers Evidence eBS Application


• TGA CA Certificate (cont.):


Schedule 3 Part 7 Clause 7.5 – System or Procedure Packs


Schedule 3 Part 7 Clause 7.5 (Cont.)

Submitting an Accurate New Manufacturers Evidence in eBS

Sponsor Reference is not seen by TGA

This information is auto filled from log-in information

The TGA may ask for documentation from the notified body when it is not clear that the scope of the certificate supports the device under review.

Submitting an Accurate New Manufacturers Evidence in eBS

• To complete your application you must attach an electronic copy of the supporting document (EC Certificate, TGA Certificate or Declaration of Conformity)

• Validate your application by clicking the button. • If there is missing data in the form the validation message will alert you • If your validation is successful, you may your application

Submitting a Variation to Manufacturers Evidence in eBS

• On the TGA eBS websit after you have logged in go to Medical Device Evidence

• Find the Evidence that needs to be varied. This can be done by searching on the Identifier, Expiry Date, User Evidence Name, Availability, NB# or Sponsor Name.

• Open the Evidence and Create a Variation by clicking • Confirmation will be given


• Go to your section and locate the variation application. You will be given the options that may have changed

• If selecting yes you will then be ask

• Select the tick boxes that apply to the change and complete the required information:


• Attach you supporting documents to the application by clicking the button • Complete the required information in the pop-up box and attach your document

• and your application

Medical device amendments to EU-Australia MRA

• The Amended MRA came into force on 1 January 2013

• To allow device manufacturers and certified bodies time to incorporate the changes the following transitional arrangements have been agreed to

Medical device amendments to EU-Australia MRA

• Conformity assessment certificates issued under the current MRA for medical devices - that will become excluded from the scope of the MRA by the Amending Agreement - will continue to be valid after the Amending Agreement comes into force until the certificate expiry date or 5 years from the date that the Amending Agreement comes into effect, whichever is earlier.

• Conformity Assessment Bodies that are designated under the current MRA to issue certificates for medical devices - that will become excluded from the scope of the MRA by the Amending Agreement - will be considered to be designated under the Amending Agreement for the purpose of maintaining such certificates until the certificate expiry date or 5 years from the date that the Amending Agreement comes into effect, whichever is earlier.

• Any new conformity assessment certificates issued under the MRA once the Amending Agreement comes into effect must be issued according to the provisions of the new Amended Agreement.

Some guidance on specific types of changes

Manufacturer Name Change TGA FCA Quality Certificate • Changes require a change request application to update the TGA

Full Quality Assurance Certificate with the new manufacturer change. Once the changes have been approved the updated certificate would then be submitted to support the variation to manufactures evidence.

EC Quality Certificate • The Sponsor would be required to update the existing evidence by

submitting a variation application, the TGA needs evidence e.g. audit report to show that this is a change to the name only and the quality system remains unchanged.


Manufacturing Address Change TGA FCA Quality Certificate • Changes require a change request application to update the TGA Full

Quality Assurance Certificate with the new manufacturer change. Once the changes have been approved the updated certificate would then be submitted to support the variation to manufactures evidence.

EC Quality Certificate • The Sponsor would be required to update the existing evidence by

submitting a variation application, the The sponsor must show the TGA that there has been no change to the quality system e.g. the factory moves and the old site is closed or the certificate changes to the companies head office but the manufacturing site remains unchanged and there are no changes to the quality system then this is allowed. If it is a new manufacturing site under a different quality system a new manufacturers evidence would be required.


• Devices move from one CE Certificate to another or the scope of the certificate changes and no longer covers some ARTG entries.

This would be considered to be a change in the ARTG and would need to be submitted as a device change request.

Keeping your Evidence up to date

• You can Export your Manufacturers Evidence information from the eBS site to a spreadsheet format in either HTML, Excel or XML formats.

• Each Manufactures Evidence will list the related active ARTG Entry

Information that the evidence supports

• If a manufacturers evidence is no longer required because there are no active ARTG entries associated you may open the evidence and

the entry.

Questions

Brought to you by:

Session B2: Medical Devices Accurate manufacturers evidence

Documents

Transcript of Session B2: Medical Devices Accurate manufacturers evidence