presentation: conformity assessment evidence

Conformity Assessment Evidence A Regulator’s Perspective

Dr Elizabeth McGrath Medical Devices Branch Medical Devices and Product Quality Division TGA 2017 Device Sponsor Training Day

Presentation overview

Definition & Background Important Concepts The Evidence Change is Coming

Conformity Assessment Evidence 2

What is conformity assessment?

Conformity Assessment: The systematic examination of evidence generated and procedures undertaken by the manufacturer, under requirements established by the Regulatory Authority, to determine that a medical device is safe and performs as intended by the manufacturer and, therefore, conforms to the Essential Principles of Safety and Performance for Medical Devices. - GHTF


What is conformity assessment?

• All Devices, unless exempt, Must Undergo Conformity Assessment according to their risk classification.

• All Medical Device Manufacturers Must Undergo Conformity Assessment certification for their QMS.

• All Devices must comply with the applicable essential principles.


CA certification can either be from TGA or from a EU notified body

• Certain Devices and their Manufacturers Require TGA certification

• Notified Bodies are designated (authorised) by Government Regulators in the EU to certify conformity assessment procedures (examine safety and performance information, assess clinical data)

TGA conformity assessment required For a device that… Regulation

Contains tissues of animal origin (non-viable) 4.1(a)

Contains tissues, cells or substances of microbial or recombinant origin 4.1(b)

Contains stable derivatives of human blood or human plasma 4.1(c)

Incorporates a substance that is considered to be a medicine 4.1(d)

Is a Class 4 IVD 4.1(e) Is a Class 4 in-house IVD (unless certain conditions met) 4.1(f)

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Important concepts


Important concept 1

“Begin at the beginning,” the King

said, very gravely, “and go on till

you come to the end, then stop.”

- Lewis Carroll

Regulator


Important concept 1 (continued)

DEVICE LIFECYCLE Conformity Assessment Evidence 9

Important concept 2

preparation

PREPARATION

PREPARATION


Evidence


The essential principles • Schedule 1 – Medical Devices

Regulations

• Set out requirements relating to the safety and performance of the medical device


Essential principles for safety and performance

1. Use of medical devices not to compromise health and safety

2. Design and construction of medical devices to conform to safety principles

3. Medical devices to be suitable for intended purpose

General principles



4. Long-term safety

5. Medical devices not to be adversely affected by transport or storage

6. Benefits of medical devices to outweigh any side effects

General principles



Principles about design and construction

7. Chemical, physical and biological properties

8. Infection and microbial contamination

9. Construction and environmental properties

10.Medical devices with a measuring function

11.Protection against radiation



12. Medical devices connected to or equipped with

an energy source

13. Information to be provided with medical devices

14. Clinical evidence

15. Principles applying to IVD medical devices only

Principles about design and construction


Demonstrating compliance


Demonstrating compliance

https://www.tga.gov.au/book-page/part-1-general-requirements Conformity Assessment Evidence 18

https://www.tga.gov.au/book-page/part-1-general-requirements

Format • Should be easy to understand/find where

information is located! • Documents should be searchable • Guidance on structuring a submission

– https://www.tga.gov.au/tga-pilot-imdrf-table-contents-medical-device-


https://www.tga.gov.au/tga-pilot-imdrf-table-contents-medical-device-

https://www.tga.gov.au/tga-pilot-imdrf-table-contents-medical-device-

Changes are on the way


Aligning the EPs and GSPRs Australian EPs @ European ERs

• Annex 1 of the new EU regulations

• Includes 23 ‘General Safety and Performance Requirements’ (GSPR) replacing ‘Essential Requirements’ (ER)

• Based on the GHTF Essential Principles 2012


New requirements in the GSPR

GSPR 10 Substances: § Justification for CMR or endocrine-disrupting substances, when present >

0.1% (w/w); § Guidelines on phthalates; § Labelling requirement on devices and packaging for above substances.

– Reduce risks linked to the size and properties of particles released into

patient’s or use’s body, particularly nanomaterials.

Requirements regarding design and manufacture


New requirements in the GSPR • GSPR 11 – Infection and microbial contamination

– Reduce risks from unintended cuts and pricks; – Design to facilitate safe cleaning, disinfection and/or re-sterilisation;

• GSPR 12 – Devices incorporating a substance considered to be a medicinal product and devices that are composed of substances or of combination of substance that are absorbed by or locally dispersed in the human body – Verified with the specified requirements laid down in Directive 2001/83/EC; – Evaluation of ADME profile, local tolerance, toxicity, interaction with other

devices.




• GSPR 14 – Construction of Devices and Interaction with Environment – designed and manufactured in such a way that adjustment, calibration, and

maintenance can be done safely and effectively. – be designed and manufactured in such a way as to facilitate their safe

disposal and the safe disposal of related waste substances by the user, patient or other person.

– manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use. Such procedures shall be described in the instructions for use.




• GSPR 17 - Software – Key changes: § software shall be developed and manufactured in accordance with the state

of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation. § requirements for software and mobile computing platforms – considerations

for size and contrast ratio of screen, level of light and noise in environment. § minimum hardware requirements, IT network characteristics, IT security

measures.



GSPR Chapter II • GSPR 18 - Active devices and devices connected to them

– Key improvements: § Immunity to electromagnetic interference;

• (currently– only minimise electromagnetic field generation) § Protect, as far as possible, against unauthorised access that could hamper

the device from functioning as intended

Requirements regarding design and manufacture – GSPR 10 - 22


New Requirements in the GSPR

• GSPR 22 – Protection against the risks posed by medical

devices intended by the manufacturer for use by lay persons − Important for home use devices; − Safety, performance, design and manufacture considering the

skills and means available to the lay person, easy to understand information.



New Requirements in the GSPR

• GSPR 23 – Numerous Changes, Including – a requirement for UDI – in the case of implantable devices, the overall qualitative and quantitative

information on the materials and substances to which patients can be exposed; – a notice to the user and/or patient that any serious incident that has occurred in

relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established;

– Implant card and information/warnings for patients

Requirements regarding information supplied with a device

Conformity Assessment Evidence

Conformity Assessment Evidence A SPONSOR’S PERSPECTIVE: PRACTICE & TIPS

Elizabeth Van Den Akker

Sponsor Information Day 11 | October | 2017

Concept 1: Begin at the beginning & go on till you come to the end…….

Conformity Assessment Evidence: A Sponsor’s Perspective


Concept 1: Begin at the beginning and go on…..

October 11, 2017

Conformity Assessment Evidence

Sponsor Information Day 33



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Early engagement § Become involved as early as possible in the product development to address EPs

§ Essential where classification differences exist in different jurisdictions

§ Proceduralise operational requirements in Quality Management System (QMS)

Device Lifecycle Changes

§ Establish formal change impact assessment process to determine CA evidence requirements

§ Have written procedures as part of QMS to cater for change management, and to guide their related decision making

§ Classify change(s) to determine if notifiable to the TGA

§ Clearly define design & process changes, their impact on EPs and any additional associated risks

§ Ensure changes are validated or a justification for non-validation is available

Sponsor Information Day

PRAC

TIC

E &

TIP

S

https://www.tga.gov.au/publication/substantial-changes-affecting-tga-conformity-assessment-certificate-and-transfers-certificates

October 11, 2017





Post-market § Establish effective post-market reporting & analytics systems

§ Post-market data provides evidence of ongoing compliance with EPs

Conformity Assessment Certification Currency § Recertification to maintain TGA CA certification currency

§ Ongoing TGA audits of manufacturing facilities

Sponsor Information Day

PRAC

TIC

E &

TIP

S

October 11, 2017 35

Concept 2: Preparation




i Information Resources § SME Assist for start-ups and small to medium enterprises

§ Pre-submission meetings with the TGA for complex CA submissions

§ TGA Guideline publications (e.g. Clinical Evidence Guidelines, Substantial Changes to TGA Conformity Assessment Certificates, ARGMD)

§ TGA website

§ Industry Associations

Collating Conformity Assessment Evidence § Review CA evidence supplied by the manufacturer and identify any gaps in compliance with EPs

§ Ensure compliance to the TGA guideline publications

§ Wherever possible demonstrate EP compliance with recognised standards published by an Australian or International Standards Agency (e.g. ISO standards)

PRAC

TIC

E &

TIP

S

Sponsor Information Day October 11, 2017 37



Collating CA Evidence (cont.)

§ Where alternate or earlier versions of standards used by manufacturer include justification and, if relevant, include any additional information/data that bridges identified gaps

§ Consider trends in TGA questions emerging from previous TGA conformity assessments of similar device(s)

Dossier format § General dossier requirements at

§ Packaging option: PDF Portfolio

https://www.tga.gov.au/book-page/part-c-formatting-your-dossier#conformity

PRAC

TIC

E &

TIP

S

Sponsor Information Day October 11, 2017 38

https://www.tga.gov.au/book-page/part-c-formatting-your-dossier#conformity

Conformity Assessment Evidence: A Sponsor’s Perspective Sponsor Information Day 11 | October | 2017

presentation: conformity assessment evidence

Health & Medicine