Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear All,

We are a medical device manufacturer and using 93/42/EEC quality system certification as the conformity evidence for Australia. 

Could you advise us if CE mark is necessary for our product under the condition below?
- All our products are manufactured under the same quality system (thus, the product are surely conforms to 93/42/EEC quality system) but we stopped some products to keep its conformance to the essential requirements. 
- Our products of course conforms to the Australian Essential Principles. 
- Our agent said it is OK for class 1 device to be without CE mark but not for class 2 or above. 

We believe it should be OK to sell class 2 or above medical device without CE mark in Australia under the condition above but could somebody advice about it?

We undergo MDSAP audit recently and would it better to change the conformity evidence to MDSAP to avoid the problem being without CE mark?

Thank you in advance for your help!

Regardless of device class, Australian medical device legislation [i.e., the Therapeutic Goods Act of 1989; the Therapeutic Goods Regulations of 1990; and the Therapeutic Goods (Medical Devices) Regulations of 2002] doesn't directly/intrinsically require a CE mark on medical devices included in the ARTG.  But it is noteworthy that, in order for the Australian Sponsor to satisfy the conformity assessment requirements of the aforesaid Australian legislation, TGA will, within prescribed boundaries, allow the use/leveraging of conformity assessment evidence from comparable overseas regulators (such as European conformity assessment evidence like EC Certificates or European QMS Certificates for class IIa devices).  In such a case, it would not be appropriate for the Australian Sponsor to provide an invalid EC or European QMS certificate, consequently meaning that such a device would at least need to be eligible for affixing the CE mark.  Yet for the actual device units sold in Australia based on such a conformity assessment, I know of no Australian requirement demanding that the units be affixed with a CE mark.

Regarding MDSAP certificates, those are amongst the types of conformity assessment evidence from comparable overseas regulators that are eligible for use in meeting TGA's conformity assessment requirements.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 04-Mar-2021 23:55
From: Anonymous Member
Subject: Medical Device in Australia without CE mark

This message was posted by a user wishing to remain anonymous

Dear All,

We are a medical device manufacturer and using 93/42/EEC quality system certification as the conformity evidence for Australia.

Could you advise us if CE mark is necessary for our product under the condition below?
- All our products are manufactured under the same quality system (thus, the product are surely conforms to 93/42/EEC quality system) but we stopped some products to keep its conformance to the essential requirements.
- Our products of course conforms to the Australian Essential Principles.
- Our agent said it is OK for class 1 device to be without CE mark but not for class 2 or above.

We believe it should be OK to sell class 2 or above medical device without CE mark in Australia under the condition above but could somebody advice about it?

We undergo MDSAP audit recently and would it better to change the conformity evidence to MDSAP to avoid the problem being without CE mark?

Thank you in advance for your help!

Hello Anon,

Kevin provided really helpful information about the requirements within Australia.  Indeed there is no requirement of a device being sold or imported into Australia requiring a CE Mark.  The Therapeutic Goods Act (through the years including small amendment in 2010) does not require CE Mark because this is specific to the European Union.  However, you can utilise CE Marking as a conformity assessment route which requires "less" review by TGA - which is also quite common in other countries utilising home country approval or other approvals like FDA clearance or CE Marking to facilitate the registration/certification process.  Your Australian Sponsor telling you Class II and above needs a CE Mark is probably saying that to make their life easier.  Registration in ARTG with a Class II or above without a CE Mark involves more documentation, technical documentation, and labelling information.  Also as Australia participates in the MDSAP programme, this can also be utilised as a conformity assessment pathway but realise this only applies to the quality management system, not to the technical information related to the device such as safety and performance against the Essential Principle requirements.  The registration process basically for any other class than Class I has an application audit - a CE Mark helps facilitate the need for not doing an application audit since as CE Mark it has already going through a technical review by a Notified Body (which as some may know TGA was a Notified Body themselves under the EU MDD).  So no, there is no requirement for a CE Mark, but having this may help the registration process in ARTG.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 05-Mar-2021 17:19
From: Kevin Randall
Subject: Medical Device in Australia without CE mark

Regardless of device class, Australian medical device legislation [i.e., the Therapeutic Goods Act of 1989; the Therapeutic Goods Regulations of 1990; and the Therapeutic Goods (Medical Devices) Regulations of 2002] doesn't directly/intrinsically require a CE mark on medical devices included in the ARTG.  But it is noteworthy that, in order for the Australian Sponsor to satisfy the conformity assessment requirements of the aforesaid Australian legislation, TGA will, within prescribed boundaries, allow the use/leveraging of conformity assessment evidence from comparable overseas regulators (such as European conformity assessment evidence like EC Certificates or European QMS Certificates for class IIa devices).  In such a case, it would not be appropriate for the Australian Sponsor to provide an invalid EC or European QMS certificate, consequently meaning that such a device would at least need to be eligible for affixing the CE mark.  Yet for the actual device units sold in Australia based on such a conformity assessment, I know of no Australian requirement demanding that the units be affixed with a CE mark.

Regarding MDSAP certificates, those are amongst the types of conformity assessment evidence from comparable overseas regulators that are eligible for use in meeting TGA's conformity assessment requirements.

------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 04-Mar-2021 23:55
From: Anonymous Member
Subject: Medical Device in Australia without CE mark

This message was posted by a user wishing to remain anonymous

Dear All,

We are a medical device manufacturer and using 93/42/EEC quality system certification as the conformity evidence for Australia.

Could you advise us if CE mark is necessary for our product under the condition below?
- All our products are manufactured under the same quality system (thus, the product are surely conforms to 93/42/EEC quality system) but we stopped some products to keep its conformance to the essential requirements.
- Our products of course conforms to the Australian Essential Principles.
- Our agent said it is OK for class 1 device to be without CE mark but not for class 2 or above.

We believe it should be OK to sell class 2 or above medical device without CE mark in Australia under the condition above but could somebody advice about it?

We undergo MDSAP audit recently and would it better to change the conformity evidence to MDSAP to avoid the problem being without CE mark?

Thank you in advance for your help!

Dear Anonymous

 

Since 2018, the EU CE mark has been recognized by the Australian Government Department of Health Therapeutic Goods Adminstration (TGA) as well as MDSAP. Please see the quote below taken from:

https://www.tga.gov.au/comparable-overseas-regulators-medical-device-applications

 

"The TGA has long accepted certification from European notified bodies as evidence of compliance with the conformity assessment procedures, in addition to the conformity assessment certificates issued by the TGA.

Since October 2018, comparable overseas regulators and assessment bodies include:

• Notified bodies designated by the medical device regulators of European member states, under the medical device regulatory frameworks of the European Union
• the Food and Drug Administration of the United States
• Health Canada
• Medical Device Single Audit Program (MDSAP) Auditing Organisation
• the Ministry of Health, Labour and Welfare and Pharmaceutical and Medical Devices Agency of Japan."

Class I medical device conformity assessment requirements are different to those of higher risk classification devices.

Here you will find guidance specific to class I medical device declaration of conformity:

https://www.tga.gov.au/resource/guidance-declaration-conformity-class-i-non-sterile-non-measuring-and-class-1-vitro-diagnostic-ivd-medical-devices

 

Furthermore, a chart maps the TGA regulatory requirements to EU MDD (MDD CE certification) for all medical device risk classifications.

https://www.tga.gov.au/form/declaration-conformity-templates-medical-devices


Best Regards,
Stephanie

------------------------------
Stephanie Grassmann
Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
------------------------------

Original Message:
Sent: 04-Mar-2021 23:55
From: Anonymous Member
Subject: Medical Device in Australia without CE mark

This message was posted by a user wishing to remain anonymous

Dear All,

We are a medical device manufacturer and using 93/42/EEC quality system certification as the conformity evidence for Australia.

Could you advise us if CE mark is necessary for our product under the condition below?
- All our products are manufactured under the same quality system (thus, the product are surely conforms to 93/42/EEC quality system) but we stopped some products to keep its conformance to the essential requirements.
- Our products of course conforms to the Australian Essential Principles.
- Our agent said it is OK for class 1 device to be without CE mark but not for class 2 or above.

We believe it should be OK to sell class 2 or above medical device without CE mark in Australia under the condition above but could somebody advice about it?

We undergo MDSAP audit recently and would it better to change the conformity evidence to MDSAP to avoid the problem being without CE mark?

Thank you in advance for your help!

It's not clear if this question is about the labelling or the certification.

First - labelling :  Australia (TGA) does not require a CE mark on labelling, but neither does it object to one.

Second, regulatory approval.  There are multiple pathways... 

1. Direct TGA assessment using processes and requirements closely similar to the European.  TGA is updating some regulations e.g. classification to realign with MDR.

2. Presentation of CE certificate 

3.  Presentation of FDA clearance or PMA PLUS MDSAP

4.  Presentation of Canadian license + MDSAP

5.  Presentation of Japanese Shonin or Ninsho + Japanese QMS certification.

There are lots of wrinkles in the detail, especially that classifications need to line up (big problem for US 510k cleared devices if they are class III in Australia, as TGA would require a PMA approval to accept the US evidence. 

Also, higher risk devices are subject to a follow on desktop review by TGA known as an Application Audit, and these are currently taking a long time.


For much more detail see https://brandwoodckc.com/videos/taking-a-510k-down-underleveraging-us-and-canadian-and-japanese-approvals-for-tga-registration/ 

Message me with any questions... 

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@gmail.com
www.brandwoodckc.com
------------------------------

Original Message:
Sent: 04-Mar-2021 23:55
From: Anonymous Member
Subject: Medical Device in Australia without CE mark

This message was posted by a user wishing to remain anonymous

Dear All,

We are a medical device manufacturer and using 93/42/EEC quality system certification as the conformity evidence for Australia.

Could you advise us if CE mark is necessary for our product under the condition below?
- All our products are manufactured under the same quality system (thus, the product are surely conforms to 93/42/EEC quality system) but we stopped some products to keep its conformance to the essential requirements.
- Our products of course conforms to the Australian Essential Principles.
- Our agent said it is OK for class 1 device to be without CE mark but not for class 2 or above.

We believe it should be OK to sell class 2 or above medical device without CE mark in Australia under the condition above but could somebody advice about it?

We undergo MDSAP audit recently and would it better to change the conformity evidence to MDSAP to avoid the problem being without CE mark?

Thank you in advance for your help!

Not sure TGA recognises at all a 510(k) clearance as conformity assessment evidence anymore, recently for a class Is , a PMA was required.

regards,

Rashmi

------------------------------
Rashmi
------------------------------

Original Message:
Sent: 07-Mar-2021 01:13
From: Arthur Brandwood
Subject: Medical Device in Australia without CE mark

It's not clear if this question is about the labelling or the certification.

First - labelling :  Australia (TGA) does not require a CE mark on labelling, but neither does it object to one.

Second, regulatory approval.  There are multiple pathways...

1. Direct TGA assessment using processes and requirements closely similar to the European.  TGA is updating some regulations e.g. classification to realign with MDR.

2. Presentation of CE certificate

3.  Presentation of FDA clearance or PMA PLUS MDSAP

4.  Presentation of Canadian license + MDSAP

5.  Presentation of Japanese Shonin or Ninsho + Japanese QMS certification.

There are lots of wrinkles in the detail, especially that classifications need to line up (big problem for US 510k cleared devices if they are class III in Australia, as TGA would require a PMA approval to accept the US evidence.

Also, higher risk devices are subject to a follow on desktop review by TGA known as an Application Audit, and these are currently taking a long time.


For much more detail see https://brandwoodckc.com/videos/taking-a-510k-down-underleveraging-us-and-canadian-and-japanese-approvals-for-tga-registration/

Message me with any questions...

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@gmail.com
www.brandwoodckc.com

Original Message:
Sent: 04-Mar-2021 23:55
From: Anonymous Member
Subject: Medical Device in Australia without CE mark

This message was posted by a user wishing to remain anonymous

Dear All,

We are a medical device manufacturer and using 93/42/EEC quality system certification as the conformity evidence for Australia.

Could you advise us if CE mark is necessary for our product under the condition below?
- All our products are manufactured under the same quality system (thus, the product are surely conforms to 93/42/EEC quality system) but we stopped some products to keep its conformance to the essential requirements.
- Our products of course conforms to the Australian Essential Principles.
- Our agent said it is OK for class 1 device to be without CE mark but not for class 2 or above.

We believe it should be OK to sell class 2 or above medical device without CE mark in Australia under the condition above but could somebody advice about it?

We undergo MDSAP audit recently and would it better to change the conformity evidence to MDSAP to avoid the problem being without CE mark?

Thank you in advance for your help!

Rashmi,  as noted in my earlier reply, the challenge with US FDA evidence is that classifications don't always line up.  There are some devices which have a 510(k) as they are Class II in the US, but which are Class III in Australia.

Are you able to share more detail on the type of device which raised the request for PMA?  

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@gmail.com
www.brandwoodckc.com
------------------------------

Original Message:
Sent: 07-Mar-2021 03:54
From: Rashmi Pillay
Subject: Medical Device in Australia without CE mark

Not sure TGA recognises at all a 510(k) clearance as conformity assessment evidence anymore, recently for a class Is , a PMA was required.

regards,

Rashmi

------------------------------
Rashmi

Original Message:
Sent: 07-Mar-2021 01:13
From: Arthur Brandwood
Subject: Medical Device in Australia without CE mark

It's not clear if this question is about the labelling or the certification.

First - labelling :  Australia (TGA) does not require a CE mark on labelling, but neither does it object to one.

Second, regulatory approval.  There are multiple pathways...

1. Direct TGA assessment using processes and requirements closely similar to the European.  TGA is updating some regulations e.g. classification to realign with MDR.

2. Presentation of CE certificate

3.  Presentation of FDA clearance or PMA PLUS MDSAP

4.  Presentation of Canadian license + MDSAP

5.  Presentation of Japanese Shonin or Ninsho + Japanese QMS certification.

There are lots of wrinkles in the detail, especially that classifications need to line up (big problem for US 510k cleared devices if they are class III in Australia, as TGA would require a PMA approval to accept the US evidence.

Also, higher risk devices are subject to a follow on desktop review by TGA known as an Application Audit, and these are currently taking a long time.


For much more detail see https://brandwoodckc.com/videos/taking-a-510k-down-underleveraging-us-and-canadian-and-japanese-approvals-for-tga-registration/

Message me with any questions...

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@gmail.com
www.brandwoodckc.com

Original Message:
Sent: 04-Mar-2021 23:55
From: Anonymous Member
Subject: Medical Device in Australia without CE mark

This message was posted by a user wishing to remain anonymous

Dear All,

We are a medical device manufacturer and using 93/42/EEC quality system certification as the conformity evidence for Australia.

Could you advise us if CE mark is necessary for our product under the condition below?
- All our products are manufactured under the same quality system (thus, the product are surely conforms to 93/42/EEC quality system) but we stopped some products to keep its conformance to the essential requirements.
- Our products of course conforms to the Australian Essential Principles.
- Our agent said it is OK for class 1 device to be without CE mark but not for class 2 or above.

We believe it should be OK to sell class 2 or above medical device without CE mark in Australia under the condition above but could somebody advice about it?

We undergo MDSAP audit recently and would it better to change the conformity evidence to MDSAP to avoid the problem being without CE mark?

Thank you in advance for your help!

Original Message:
Sent: 3/7/2021 8:18:00 PM
From: Arthur Brandwood
Subject: RE: Medical Device in Australia without CE mark

Rashmi,  as noted in my earlier reply, the challenge with US FDA evidence is that classifications don't always line up.  There are some devices which have a 510(k) as they are Class II in the US, but which are Class III in Australia.

Are you able to share more detail on the type of device which raised the request for PMA?  

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@gmail.com
www.brandwoodckc.com
------------------------------

Original Message:
Sent: 07-Mar-2021 03:54
From: Rashmi Pillay
Subject: Medical Device in Australia without CE mark

Not sure TGA recognises at all a 510(k) clearance as conformity assessment evidence anymore, recently for a class Is , a PMA was required.

regards,

Rashmi

------------------------------
Rashmi

Original Message:
Sent: 07-Mar-2021 01:13
From: Arthur Brandwood
Subject: Medical Device in Australia without CE mark

It's not clear if this question is about the labelling or the certification.

First - labelling :  Australia (TGA) does not require a CE mark on labelling, but neither does it object to one.

Second, regulatory approval.  There are multiple pathways...

1. Direct TGA assessment using processes and requirements closely similar to the European.  TGA is updating some regulations e.g. classification to realign with MDR.

2. Presentation of CE certificate

3.  Presentation of FDA clearance or PMA PLUS MDSAP

4.  Presentation of Canadian license + MDSAP

5.  Presentation of Japanese Shonin or Ninsho + Japanese QMS certification.

There are lots of wrinkles in the detail, especially that classifications need to line up (big problem for US 510k cleared devices if they are class III in Australia, as TGA would require a PMA approval to accept the US evidence.

Also, higher risk devices are subject to a follow on desktop review by TGA known as an Application Audit, and these are currently taking a long time.


For much more detail see https://brandwoodckc.com/videos/taking-a-510k-down-underleveraging-us-and-canadian-and-japanese-approvals-for-tga-registration/

Message me with any questions...

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@gmail.com
www.brandwoodckc.com

Original Message:
Sent: 04-Mar-2021 23:55
From: Anonymous Member
Subject: Medical Device in Australia without CE mark

This message was posted by a user wishing to remain anonymous

Dear All,

We are a medical device manufacturer and using 93/42/EEC quality system certification as the conformity evidence for Australia.

Could you advise us if CE mark is necessary for our product under the condition below?
- All our products are manufactured under the same quality system (thus, the product are surely conforms to 93/42/EEC quality system) but we stopped some products to keep its conformance to the essential requirements.
- Our products of course conforms to the Australian Essential Principles.
- Our agent said it is OK for class 1 device to be without CE mark but not for class 2 or above.

We believe it should be OK to sell class 2 or above medical device without CE mark in Australia under the condition above but could somebody advice about it?

We undergo MDSAP audit recently and would it better to change the conformity evidence to MDSAP to avoid the problem being without CE mark?

Thank you in advance for your help!

OK - Clarification of the specific case raised by Rashmi.

TGA are certainly still accepting 510(k) as supporting evidence for Australian approval.  But (as per earlier post) for applications supported by US, Japanese or Canadian approvals, TGA also require manufacturers QMS evidence in addition to the primary product evidence.  This needs to be in the form of MDSAP. Japanese QMS or a regulatory review which includes a full regulatory audit (Such as a US PMA  - which requires an up front QSR audit by FDA).  

The 510(k) alone is not enough.

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@gmail.com
www.brandwoodckc.com
------------------------------

Original Message:
Sent: 07-Mar-2021 20:17
From: Arthur Brandwood
Subject: Medical Device in Australia without CE mark

Rashmi,  as noted in my earlier reply, the challenge with US FDA evidence is that classifications don't always line up.  There are some devices which have a 510(k) as they are Class II in the US, but which are Class III in Australia.

Are you able to share more detail on the type of device which raised the request for PMA?

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@gmail.com
www.brandwoodckc.com

Original Message:
Sent: 07-Mar-2021 03:54
From: Rashmi Pillay
Subject: Medical Device in Australia without CE mark

Not sure TGA recognises at all a 510(k) clearance as conformity assessment evidence anymore, recently for a class Is , a PMA was required.

regards,

Rashmi

------------------------------
Rashmi

Original Message:
Sent: 07-Mar-2021 01:13
From: Arthur Brandwood
Subject: Medical Device in Australia without CE mark

It's not clear if this question is about the labelling or the certification.

First - labelling :  Australia (TGA) does not require a CE mark on labelling, but neither does it object to one.

Second, regulatory approval.  There are multiple pathways...

1. Direct TGA assessment using processes and requirements closely similar to the European.  TGA is updating some regulations e.g. classification to realign with MDR.

2. Presentation of CE certificate

3.  Presentation of FDA clearance or PMA PLUS MDSAP

4.  Presentation of Canadian license + MDSAP

5.  Presentation of Japanese Shonin or Ninsho + Japanese QMS certification.

There are lots of wrinkles in the detail, especially that classifications need to line up (big problem for US 510k cleared devices if they are class III in Australia, as TGA would require a PMA approval to accept the US evidence.

Also, higher risk devices are subject to a follow on desktop review by TGA known as an Application Audit, and these are currently taking a long time.


For much more detail see https://brandwoodckc.com/videos/taking-a-510k-down-underleveraging-us-and-canadian-and-japanese-approvals-for-tga-registration/

Message me with any questions...

Arthur

------------------------------
Arthur Brandwood PhD FRAPS
Director and Principal Consultant
Brandwood CKC
Sydney, Australia
Arthur.brandwood@gmail.com
www.brandwoodckc.com

Original Message:
Sent: 04-Mar-2021 23:55
From: Anonymous Member
Subject: Medical Device in Australia without CE mark

This message was posted by a user wishing to remain anonymous

Dear All,

We are a medical device manufacturer and using 93/42/EEC quality system certification as the conformity evidence for Australia.

Could you advise us if CE mark is necessary for our product under the condition below?
- All our products are manufactured under the same quality system (thus, the product are surely conforms to 93/42/EEC quality system) but we stopped some products to keep its conformance to the essential requirements.
- Our products of course conforms to the Australian Essential Principles.
- Our agent said it is OK for class 1 device to be without CE mark but not for class 2 or above.

We believe it should be OK to sell class 2 or above medical device without CE mark in Australia under the condition above but could somebody advice about it?

We undergo MDSAP audit recently and would it better to change the conformity evidence to MDSAP to avoid the problem being without CE mark?

Thank you in advance for your help!

This message was posted by a user wishing to remain anonymous

Thank you so much for everyone!  
All your advices are of great help and I will discuss with our R&D members.
Original Message:
Sent: 04-Mar-2021 23:55
From: Anonymous Member
Subject: Medical Device in Australia without CE mark

This message was posted by a user wishing to remain anonymous

Dear All,

We are a medical device manufacturer and using 93/42/EEC quality system certification as the conformity evidence for Australia.

Could you advise us if CE mark is necessary for our product under the condition below?
- All our products are manufactured under the same quality system (thus, the product are surely conforms to 93/42/EEC quality system) but we stopped some products to keep its conformance to the essential requirements.
- Our products of course conforms to the Australian Essential Principles.
- Our agent said it is OK for class 1 device to be without CE mark but not for class 2 or above.

We believe it should be OK to sell class 2 or above medical device without CE mark in Australia under the condition above but could somebody advice about it?

We undergo MDSAP audit recently and would it better to change the conformity evidence to MDSAP to avoid the problem being without CE mark?

Thank you in advance for your help!

Arthur - Devices under Interim Order approval in Canada also apply or no?

------------------------------
Edward Panek
VP, QA/RA
Med Device

DOD/DARPA/Dept Veterans Affairs Design Controls in Research

Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 07-Mar-2021 17:59
From: Anonymous Member
Subject: Medical Device in Australia without CE mark

This message was posted by a user wishing to remain anonymous

Thank you so much for everyone!
All your advices are of great help and I will discuss with our R&D members.
Original Message:
Sent: 04-Mar-2021 23:55
From: Anonymous Member
Subject: Medical Device in Australia without CE mark

This message was posted by a user wishing to remain anonymous

Dear All,

We are a medical device manufacturer and using 93/42/EEC quality system certification as the conformity evidence for Australia.

Could you advise us if CE mark is necessary for our product under the condition below?
- All our products are manufactured under the same quality system (thus, the product are surely conforms to 93/42/EEC quality system) but we stopped some products to keep its conformance to the essential requirements.
- Our products of course conforms to the Australian Essential Principles.
- Our agent said it is OK for class 1 device to be without CE mark but not for class 2 or above.

We believe it should be OK to sell class 2 or above medical device without CE mark in Australia under the condition above but could somebody advice about it?

We undergo MDSAP audit recently and would it better to change the conformity evidence to MDSAP to avoid the problem being without CE mark?

Thank you in advance for your help!