How does Australia handle products that are EU PPE, but Australia Medical Devices?

[MIREGMGR]

The product is a medical device according to USA, China, Brazil, Canada and Australia definitions. It's Class I Exempt and Listed as a device in USA, and formally accepted as a device by China and Brazil regulators. When we arranged for our Australian distributor to register it as Sponsor, we were self-certification CE Marking it as a medical device. Since then, we have entered into a relationship with a second NB solely for EU and for the product in question, and they have determined the product is PPE and not a medical device for EU. They are requiring us to cease applying our MDD self-certification CE Mark.

We want to have a single global product regulatorily.

Australia of course references an existing EU CE Mark on a low risk medical device as sufficient evidence that the product may be marketed in Australia. My reading of the Australian rules indicates that the regulators assumed that if a product was CE Marked for EU and met the Australian definition of medical device, the EU CE Mark would be with regard to MDD. Is there a precedent or guidance that I haven't found yet for what to do when the Australian-medical-device product is CE Marked for EU marketing, but as PPE?

 

[Ronen E]

Re: How does Australia handle products that are EU PPE, but Australia Medical Devices

The product is a medical device according to USA, China, Brazil, Canada and Australia definitions. It's Class I Exempt and Listed as a device in USA, and formally accepted as a device by China and Brazil regulators. When we arranged for our Australian distributor to register it as Sponsor, we were self-certification CE Marking it as a medical device. Since then, we have entered into a relationship with a second NB solely for EU and for the product in question, and they have determined the product is PPE and not a medical device for EU. They are requiring us to cease applying our MDD self-certification CE Mark.

We want to have a single global product regulatorily.

Australia of course references an existing EU CE Mark on a low risk medical device as sufficient evidence that the product may be marketed in Australia. My reading of the Australian rules indicates that the regulators assumed that if a product was CE Marked for EU and met the Australian definition of medical device, the EU CE Mark would be with regard to MDD. Is there a precedent or guidance that I haven't found yet for what to do when the Australian-medical-device product is CE Marked for EU marketing, but as PPE?

As much as I understand, if clearance under the MDD is not available, the TGA will expect full compliance with its own applicable requirements set. As stated in the ARGMD s. 7 (p. 141):

In cases where there are differences in the classification of a device between Australia and the EU, the conformity assessment procedure requirements may be different in Australia. The manufacturer may be required to obtain additional conformity assessment evidence. Where the manufacturer is not able to obtain the appropriate additional conformity assessment evidence from their EU Notified Body, they may need to obtain a TGA Conformity Assessment Certificate.

 

[MIREGMGR]

Re: How does Australia handle products that are EU PPE, but Australia Medical Devices

As much as I understand, if clearance under the MDD is not available, the TGA will expect full compliance with its own applicable requirements set. As stated in the ARGMD s. 7 (p. 141):

In cases where there are differences in the classification of a device between Australia and the EU, the conformity assessment procedure requirements may be different in Australia. The manufacturer may be required to obtain additional conformity assessment evidence. Where the manufacturer is not able to obtain the appropriate additional conformity assessment evidence from their EU Notified Body, they may need to obtain a TGA Conformity Assessment Certificate.

What does this mean in practice? I think the above quotation literally pertains to differences in medical device risk class, not to the rather arcane medical-device-vs-PPE question. Is there a way to know if the quotation was also intended by TGA to encompass the latter issue?

The product in question has been on the US market for several years as a medical device, and was registered in Australia on that basis some time ago by our distributor there.

More recently, our EU distributor decided that the product would sell better in the EU as PPE, so we brought in a second NB to review this product because our MDD NB's scope does not include that type of PPE. Prior to the involvement of the second NB, we were self certifying the Class I product under MDD for EU sales...in my view, legitimately. Our MDD NB was actively aware of that self-certification and had no problem with it.

Given this history, what “additional conformity assessment evidence" would I have to obtain from, or under the auspices of, one or the other of our NBs? What do I do with that additional evidence, given that the product is already registered and was legitimately MDD CE Marked when that registration was done, and has not changed since that time except in regard to the applied CE Mark?

 

[Ronen E]

Re: How does Australia handle products that are EU PPE, but Australia Medical Devices

What does this mean in practice? I think the above quotation literally pertains to differences in medical device risk class, not to the rather arcane medical-device-vs-PPE question. Is there a way to know if the quotation was also intended by TGA to encompass the latter issue?

It was definitely not specifically intended for the MDD/PPE situation you're apparently in; however, from the broader ARGMD context and my acquaintance with the TGA it can be read as their general approach to all EC / Australian classification differences, not only in device risk class. The question of whether a device is considered a Medical Device or otherwise (PPE for instance) is definitely a classification issue. Regardless, the only way I know to know for sure what the TGA's stance is in this specific case is to contact them and ask directly.

The product in question has been on the US market for several years as a medical device, and was registered in Australia on that basis some time ago by our distributor there.

This statement calls for some clarification. The TGA doesn't currently have straightforward provisions in place to allow clearance based on USA market clearance. Perhaps the documentation body from the USA clearance process enabled and streamlined the Australian clearance, but other than that the fact that a medical device is regulatory cleared for the USA market provides very little (if any) shortcuts in Australia.

More recently, our EU distributor decided that the product would sell better in the EU as PPE, so we brought in a second NB to review this product because our MDD NB's scope does not include that type of PPE. Prior to the involvement of the second NB, we were self certifying the Class I product under MDD for EU sales...in my view, legitimately. Our MDD NB was actively aware of that self-certification and had no problem with it.

The fact that PPE compliance was added should not be of any detriment to the MDD compliance, as far as the TGA is concerned, provided that in fact the MDD compliance was genuine and stayed in tact over the years and process of adding the PPE compliance. I think that from the TGA perspective nothing has changed and the basis for the Australian clearance is still valid.

The only issue I see in this story is that apparently the PPE directive is applicable (and always have been) and therefore affixing the CE mark in the first instance meant that your company and the device were in compliance with it, while in fact this might have not been the case. It is the manufacturer's responsibility to identify all the EC legal instruments that provide for CE marking, and affix the CE mark only once all have been complied with, to the applicable extent.

Given this history, what “additional conformity assessment evidence" would I have to obtain from, or under the auspices of, one or the other of our NBs? What do I do with that additional evidence, given that the product is already registered and was legitimately MDD CE Marked when that registration was done, and has not changed since that time except in regard to the applied CE Mark?

Given all the above you probably don't need any additional evidence. The only thing I would have endeavored to have available (just have it ready, without submitting) is a letter from the NB that has the MDD in its scope, indicating that they are not aware of any concerns regarding the device clearance in the EC as a class I device.

 

[MIREGMGR]

Re: How does Australia handle products that are EU PPE, but Australia Medical Devices

The product in question has been on the US market for several years as a medical device, and was registered in Australia on that basis some time ago by our distributor there.

This statement calls for some clarification. The TGA doesn't currently have straightforward provisions in place to allow clearance based on USA market clearance. Perhaps the documentation body from the USA clearance process enabled and streamlined the Australian clearance, but other than that the fact that a medical device is regulatory cleared for the USA market provides very little (if any) shortcuts in Australia.

Yes, sorry, a bit of a mental slip by me during a busy afternoon, conflating two separate information elements. It's true that it was on the US market, but as you note that's not relevant to Australian clearance. More significantly it was CE Marked per MDD and on the EU market.

The fact that PPE compliance was added should not be of any detriment to the MDD compliance, as far as the TGA is concerned, provided that in fact the MDD compliance was genuine and stayed in tact over the years and process of adding the PPE compliance. I think that from the TGA perspective nothing has changed and the basis for the Australian clearance is still valid.

The only issue I see in this story is that apparently the PPE directive is applicable (and always have been) and therefore affixing the CE mark in the first instance meant that your company and the device were in compliance with it, while in fact this might have not been the case. It is the manufacturer's responsibility to identify all the EC legal instruments that provide for CE marking, and affix the CE mark only once all have been complied with, to the applicable extent.

It's not the matter I wish to explore here, but the applicability of PPED vs. MDD is difficult. My reading of the plain language of the MDD and the PPED indicates that the product is a medical device and not PPE. Our high profile MDD NB agreed (at the Vice President level) several years ago at product inception that it would be a medical device. PPE status never came up, since at the time it seemed obvious that the product did not conform to the "worn or held" requirement. Our EU distributor wanted it to additionally be PPE for marketability, so we were "encouraged" to bring in a second high profile NB, with whom they have a very close relationship, that handles that type of PPE. That NB, in addition to finding that the product is PPED based on its function even though it doesn't fit within the actual words of PPED, also unexpectedly (to me, anyway) has taken a forceful stance that and not a medical device based on their knowledge of what the writers of MDD intended even if that's not the words they wrote; and the product may not be labeled as a medical device, as a condition of their certification.

Given all the above you probably don't need any additional evidence. The only thing I would have endeavored to have available (just have it ready, without submitting) is a letter from the NB that has the MDD in its scope, indicating that they are not aware of any concerns regarding the device clearance in the EC as a class I device.

Thank you for the analysis.

 

[Ronen E]

Re: How does Australia handle products that are EU PPE, but Australia Medical Devices

and the product may not be labeled as a medical device, as a condition of their certification.

I'm not sure what it means - Did they say that the words "Medical Device" (or smilar) should not appear anywhere in the labeling? Or did they object to some specific labeling requirement (from the medical devices regulations) being addressed as part of the labeling? or something else? Most importantly - is anything from the medical devices labeling requirements (either EC or TGA, which are quite similar) missing, as a result of that condition?

 

[MIREGMGR]

Re: How does Australia handle products that are EU PPE, but Australia Medical Devices

A product may carry only one CE Mark. A parametric identifier is required to be added to the CE Mark to identify the certification body when that is relevant. Parametric identifiers sometimes are added to identify other aspects of the certification when doing so provides a benefit to the consumer or is otherwise regulatorily useful. We proposed to the second NB--the one that has issued the certification for PPE Directive conformance, and also Machinery Directive conformance subsidiary to the PPE--that we should use a two line annotation with the CE Mark to indicate on the first line their CB number, as appropriate for a PPE certification, followed by the letters "PPE"; and on the second line only the letters "MDD", indicating self-certification as a medical device.

Their response was not only would that approach be unacceptable to them, but it also would be unacceptable to them for us to include the product on an MDD Declaration of Conformance provided to our MDD EU Authorized Representative, and/or market the device as both PPE and a medical device.

As to your question about label content, there is no difference in labeling other than in regard to the CE Mark. We have contracted with the same company that serves as our MDD EU Representative to be our PPED EU Representative, so the labeling is indistinguishable in that regard.

 

[Ronen E]

Re: How does Australia handle products that are EU PPE, but Australia Medical Devices

A parametric identifier is required to be added to the CE Mark to identify the certification body when that is relevant. Parametric identifiers sometimes are added to identify other aspects of the certification when doing so provides a benefit to the consumer or is otherwise regulatorily useful.

Is this a quote from some official EC guidance / legislation? Can you please share the source so we have some common ground for this discussion?

Their response was not only would that approach be unacceptable to them, but it also would be unacceptable to them for us to include the product on an MDD Declaration of Conformance provided to our MDD EU Authorized Representative, and/or market the device as both PPE and a medical device.

So, if I understood correctly, currently this device has no effective DoC under the MDD, and it's not registered anymore with a CA via your EC rep, as a class I medical device...? If that is the case (while your MDD NB still deems this device to be a medical device), then (a) you may be in breach of the MDD; and (b) you've lost the basis for your TGA clearance.