Importing prototype without CE (dos and don'ts )

[ibreestraat]

We want to import a non-CE prototype of our successor (MDD Class I) from our mother company (manufacturer in Japan) into the UK to some tests with it .

Can someone tell me what are the dos and don'ts for this?

1. Are there special requirements for the import ?
2. Can we use the device in our office ?
3. With or without patients ?
4. At what level we need MHRA approval and/or IRB?

 

[Marcelo]

1. Are there special requirements for the import ?

You can't import a finished medical device without CE Marking into the EU, unless it's a device for clinical investigation.

2. Can we use the device in our office ?

For a clinical investigation device, only in the define sites for the investigation.

3. With or without patients ?

For a clinical investigation device, in patients, obviously.

4. At what level we need MHRA approval and/or IRB?

Before importing. You need to draw up a CE marking for the device, contact MHRA and follow it's procedure, have it's "approval"then you can import the device.

 

[Pads38]

As you are, effectively, not 'placing the device on the market' you may be able to import the product. This demands that you and your 'parent company' are part of the same economic entity.

It would also be a good idea to label the device very prominently (before shipping) along the lines of 'Caution: this medical device is not CE marked and must not be marketed or put into service'. See Article 4, paragraph 3 of the MDD.

 

[Marcelo]

As you are, effectively, not 'placing the device on the market' you may be able to import the product. This demands that you and your 'parent company' are part of the same economic entity.

It would also be a good idea to label the device very prominently (before shipping) along the lines of 'Caution: this medical device is not CE marked and must not be marketed or put into service'. See Article 4, paragraph 3 of the MDD.

I'm not sure if you mentioned Article 4, paragraph 3 only for the label, but in general it's not applicable to internal prototypes, only for medical devices (finished) that are shown. We can argue that these can include prototypes (who would know the difference?) but it's clearly not the intention of the paragraph.

Regarding the OP, unfortunately, there's no clear mention of prototypes in the directives, and manufacturers often thinks that prototypes do not need any oversight, which is not true. We may argue that initial prototypes (internal, not to be used in humans) will not comply with the regulations, but a prototype to be used in humans (usually near-finished or finished), which seems to be the case of the OP, you need to comply with the regulations, and as I mentioned, you need for it to be an investigational device.

As you need to comply with the regulation, this goes back to my previous comment, the device which does not have CE Marking (in the way to complying with the regulation, it may not have the mark itself, as Annex VII mentions) cannot be brought into Europe.

So you may not have to apply the CE Mark, but you have to comply with the CE Marking Directive. Maybe this makes things more clear.

 

[Mark Meer]

You can't import a finished medical device without CE Marking into the EU, unless it's a device for clinical investigation.
...
Regarding the OP, unfortunately, there's no clear mention of prototypes in the directives, and manufacturers often thinks that prototypes do not need any oversight, which is not true. We may argue that initial prototypes (internal, not to be used in humans) will not comply with the regulations, but a prototype to be used in humans (usually near-finished or finished), which seems to be the case of the OP, you need to comply with the regulations, and as I mentioned, you need for it to be an investigational device.

Hi Marcelo,
What about Article 21 (3) of the MDR?:

At trade fairs, exhibitions, demonstrations or similar events, Member States shall not create obstacles to the showing of devices which do not comply with this Regulation, provided a visible sign clearly indicates that such devices are intended for presentation or demonstration purposes only and cannot be made available until they have been brought into compliance with this Regulation.

Does this not imply the import of a non-CE marked devices for demonstration purposes? And if for "demonstration", this seems to imply that it is acceptable to use on humans for this purpose, no?

Not certain what the parameters are here, aside from obviously no sales or distribution. Do you know if there is any guidance that elaborates on this particular clause?

 

[Marcelo]

Hi Marcelo,
What about Article 21 (3) of the MDR?:



Does this not imply the import of a non-CE marked devices for demonstration purposes? And if for "demonstration", this seems to imply that it is acceptable to use on humans for this purpose, no?

Not certain what the parameters are here, aside from obviously no sales or distribution. Do you know if there is any guidance that elaborates on this particular clause?

No, "demonstration" here is for showing, not using. The general idea (which is more easy to understand than my comments above) is that you cannot use a device in humans if it does not comply with the regulations. Usually regulations enables this by requiring that the device is not put into market or made available (but please note that these latter terms are not standardized worldwide).

 

[Mark Meer]

No, "demonstration" here is for showing, not using. The general idea (which is more easy to understand than my comments above) is that you cannot use a device in humans if it does not comply with the regulations. Usually regulations enables this by requiring that the device is not put into market or made available (but please note that these latter terms are not standardized worldwide).

If this is the case, it's curious that they would have separated terms "presentation" (which I'd interpret as "showing"), versus "demonstration" (which I'd interpret as demonstrating the device in action). In many (most?) cases it'd be very difficult to properly demonstrate a device without involving a subject at some level.

Is this a matter of interpretation of the text of the regulation, or is there actually some official guidance available? (not that I don't trust your expertise )

 

[Marcelo]

The usual name for this, including in other languages as far as I know, is demonstration at trade show. I've never seen the term being used as "showing at a trade show". But again, AFAIK, this does not imply use in humans.

 

[Marcelo]

I don't remember seeing any guidance on this, but there's this Health Canada letter to an association which makes it very clear: "The importation of health products and cosmetics for trade shows and similars".

 

[Ronen E]

In many (most?) cases it'd be very difficult to properly demonstrate a device without involving a subject at some level.

Maybe many, not most IMO. If you'd consider the entire range of medical devices you'd realize that in most cases some level of demonstration (which I take to include some level of action or simulated use) is quite possible without a human subject.

Besides, please note that the Article's text uses both the terms "demonstration" and "presentation" in relation to the sign that must be provided, and that the actual requirement relates to "the showing of".