Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello community, 

Can someone help me with which regulatory requirements would apply in regions outside of EU for a diagnostic service offered to persons located there, with a medical device which is operated in the EU? So patient and clinician are outside the EU, the device is used in the EU and is CE marked. 

In MDR, there is recital 21 which makes that in the opposite situation, the device still needs to comply with the regulation. 

(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union comply with the requirements of this Regulation, where the product in question is placed on the market or the service is provided in the Union.

I have looked for example at Singapore and Canada medical device regulations, and so far have not yet been able to find something equivalent there.
Any insights into regions you are aware of, or directions to interesting resources or to consultancy firms who can help with this question, are welcome!

Thanks!

Hello Anon,

In almost all regulated countries, if the product is being used with/for the patient in that country, than those local regulations apply.  As example, if a company sells a software application medical device (SaMD) where the company is located in Belgium, product is CE Marked, but the product is used in Canada, then Canadian regulations would apply.  Many of the regulations are not that specific such as in Europe, but selling, distributing, placing on the market, using, etc., in a country would have those local regulations apply.

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

Original Message:
Sent: 22-Nov-2021 04:45
From: Anonymous Member
Subject: International services with medical device operated in EU

This message was posted by a user wishing to remain anonymous

Hello community,

Can someone help me with which regulatory requirements would apply in regions outside of EU for a diagnostic service offered to persons located there, with a medical device which is operated in the EU? So patient and clinician are outside the EU, the device is used in the EU and is CE marked.

In MDR, there is recital 21 which makes that in the opposite situation, the device still needs to comply with the regulation.

(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union comply with the requirements of this Regulation, where the product in question is placed on the market or the service is provided in the Union.

I have looked for example at Singapore and Canada medical device regulations, and so far have not yet been able to find something equivalent there.
Any insights into regions you are aware of, or directions to interesting resources or to consultancy firms who can help with this question, are welcome!

Thanks!

This message was posted by a user wishing to remain anonymous

Hello Richard, 

Thank you for the response! 

The situation I'm trying to figure out is a bit more complicated: it would be SaMD which is not used in let's say Canda, it is used by (trained) operators in the EU who receive input files from a clinician. The results that the operator obtains by using the SaMD with those input files, are then shared with the clinician. The device itself is not sold or offered to anyone in Canada in this situation (and thus not placed on the market there), only the service is.

A similar situation would be an IVD test that is used in a physical lab which is located in the EU and processes samples of patients who are located outside of the EU. The clinician ships the patient sample to the EU-based lab, the lab tech uses the IVD test on the sample, and shares the results with the clinician.
Original Message:
Sent: 23-Nov-2021 04:42
From: Richard Vincins
Subject: International services with medical device operated in EU

Hello Anon,

In almost all regulated countries, if the product is being used with/for the patient in that country, than those local regulations apply.  As example, if a company sells a software application medical device (SaMD) where the company is located in Belgium, product is CE Marked, but the product is used in Canada, then Canadian regulations would apply.  Many of the regulations are not that specific such as in Europe, but selling, distributing, placing on the market, using, etc., in a country would have those local regulations apply.

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

Original Message:
Sent: 22-Nov-2021 04:45
From: Anonymous Member
Subject: International services with medical device operated in EU

This message was posted by a user wishing to remain anonymous

Hello community,

Can someone help me with which regulatory requirements would apply in regions outside of EU for a diagnostic service offered to persons located there, with a medical device which is operated in the EU? So patient and clinician are outside the EU, the device is used in the EU and is CE marked.

In MDR, there is recital 21 which makes that in the opposite situation, the device still needs to comply with the regulation.

(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union comply with the requirements of this Regulation, where the product in question is placed on the market or the service is provided in the Union.

I have looked for example at Singapore and Canada medical device regulations, and so far have not yet been able to find something equivalent there.
Any insights into regions you are aware of, or directions to interesting resources or to consultancy firms who can help with this question, are welcome!

Thanks!

Interesting question! Diagnostic service: are we talking IVD or medical device? Software receiving input files can be either a medical device or an IVD for EU purposes. 
First step would be to determine if the device that is used in the Union (not EU, Union for MDR and IVDR purposes includes additional countries that are not EU members) was placed on the market in the Union, which it may well be if it is located in a Union hospital lab for example. In that case Union law (MDR and IVDR) is agnostic about where the test results go. If it is placed on the market and used in the Union, it is subject to MDR or IVDR controls, even if the test results are exported.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 22-Nov-2021 04:45
From: Anonymous Member
Subject: International services with medical device operated in EU

This message was posted by a user wishing to remain anonymous

Hello community,

Can someone help me with which regulatory requirements would apply in regions outside of EU for a diagnostic service offered to persons located there, with a medical device which is operated in the EU? So patient and clinician are outside the EU, the device is used in the EU and is CE marked.

In MDR, there is recital 21 which makes that in the opposite situation, the device still needs to comply with the regulation.

(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union comply with the requirements of this Regulation, where the product in question is placed on the market or the service is provided in the Union.

I have looked for example at Singapore and Canada medical device regulations, and so far have not yet been able to find something equivalent there.
Any insights into regions you are aware of, or directions to interesting resources or to consultancy firms who can help with this question, are welcome!

Thanks!

This message was posted by a user wishing to remain anonymous

Thank you Erik! The input files are coming from a medical device, so looking at MDR. 

I agree that in this situation indeed the device is subject to MDR controls. What I am mainly wondering is whether in addition to that, local legislation of the country where the test results are exported to also needs to be considered.

From the opposite perspective, I understand from recital 21 in MDR that for a device operated in Canada but results exported to the Union (thanks for that clarification!) the device must be compliant with the MDR, because the service is in that case offered to persons within the Union.
It makes perfect sense to me that European patients are protected by European legislation regardless of where the device is operated, yet I am unsure whether the same principle is applied in countries outside of the Union, or if Europe is quite unique in this.
Original Message:
Sent: 24-Nov-2021 02:29
From: Erik Vollebregt
Subject: International services with medical device operated in EU

Interesting question! Diagnostic service: are we talking IVD or medical device? Software receiving input files can be either a medical device or an IVD for EU purposes.
First step would be to determine if the device that is used in the Union (not EU, Union for MDR and IVDR purposes includes additional countries that are not EU members) was placed on the market in the Union, which it may well be if it is located in a Union hospital lab for example. In that case Union law (MDR and IVDR) is agnostic about where the test results go. If it is placed on the market and used in the Union, it is subject to MDR or IVDR controls, even if the test results are exported.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 22-Nov-2021 04:45
From: Anonymous Member
Subject: International services with medical device operated in EU

This message was posted by a user wishing to remain anonymous

Hello community,

Can someone help me with which regulatory requirements would apply in regions outside of EU for a diagnostic service offered to persons located there, with a medical device which is operated in the EU? So patient and clinician are outside the EU, the device is used in the EU and is CE marked.

In MDR, there is recital 21 which makes that in the opposite situation, the device still needs to comply with the regulation.

(21) It should be made clear that it is essential that devices offered to persons in the Union by means of information society services within the meaning of Directive (EU) 2015/1535 of the European Parliament and of the Council (1) and devices used in the context of a commercial activity to provide a diagnostic or therapeutic service to persons within the Union comply with the requirements of this Regulation, where the product in question is placed on the market or the service is provided in the Union.

I have looked for example at Singapore and Canada medical device regulations, and so far have not yet been able to find something equivalent there.
Any insights into regions you are aware of, or directions to interesting resources or to consultancy firms who can help with this question, are welcome!

Thanks!