Regulatory Open Forum

Dear all,

For our UK market we are planning to launch a web shop for one of our products (class IIb implantable, currently MDD approved, but soon MDR approved) as a pilot. The product is intended for professional use. At the moment we are selling our products via an UK distributor (which is also the importer). For this pilot via a web shop, we are going to sell our products directly to hospitals/clinics and end-users. 

How does this work in terms of 'importers' due to the fact all importers should be listed in the UK database. Are end-users considered as importers and is there a difference for MDD products vs MDR products? 
And if end-users and considered as importers, how to manage this in case of selling to multiple end-users? Do we have to include all end-users in the UK database? This seems very impractical, is there a 'common sense  way' to handle this?

Thank you

Generally speaking, end users are not considered to be importers.  This is the same for the UK and the MDD/MDR alike.  For example, the European Commission's Directorate-General (DG) for Health and Food Safety advised me of that interpretation regarding the MDR.  For the UK, end users don't generally meet the UK regulations' trigger for "supply" or placing on the market.  If instead the end user places the devices on the market or makes them further available on the market, then UK MDR regulatory obligations would ensue.  As long as the end user only uses the devices for their own particular end use, then they aren't supplying or placing the devices on the market.  Note that end users can however trigger certain requirements regarding custom-made devices.

Dear all,

For our UK market we are planning to launch a web shop for one of our products (class IIb implantable, currently MDD approved, but soon MDR approved) as a pilot. The product is intended for professional use. At the moment we are selling our products via an UK distributor (which is also the importer). For this pilot via a web shop, we are going to sell our products directly to hospitals/clinics and end-users. 

How does this work in terms of 'importers' due to the fact all importers should be listed in the UK database. Are end-users considered as importers and is there a difference for MDD products vs MDR products? 
And if end-users and considered as importers, how to manage this in case of selling to multiple end-users? Do we have to include all end-users in the UK database? This seems very impractical, is there a 'common sense  way' to handle this?

Thank you

Dear Anonymous,

Thank you for forwarding your questions. Kevin provided the correct answer-no MDR article 13 Importer requirements for the end user. However, it's worth noting that there may be local regulations for products sold directly to consumers in certain countries. Some products may require pharmacy involvement. It is recommended to check for any restrictions on direct sales to patients for a Class IIb implantable product, considering local distribution requirements. For example, in Germany, initially, COVID tests could only be performed by professionals due to specific objectives, but this changed during the pandemic. This illustrates local variations in distribution requirements, distinct from CE Marking requirements, and these can differ from country to country. Additionally, reimbursement policies may impact product distribution.

As I write this, it occurred to me that you might be referring to an Annex XVI product. I find it interesting, and I cannot imagine there would be any restrictions, but please share if there are any specific considerations in this context.

Dera Kevin,

You have nicely outlined that the Importer requirements, according to Article 13, do not apply to the end user, whether it is a healthcare provider, laboratory (for IVDs), or the patient himself.

Thank you for sharing your information retrieved directly from the Commission directly. Would you be able to share the actual feedback? Certainly, respecting GDPR, the name may be deleted.

I do not understand the last comment. Custom-made device. If I am a patient and I change my medical device to my needs, what should I do?  Look at the MDR?

Generally speaking, end users are not considered to be importers.  This is the same for the UK and the MDD/MDR alike.  For example, the European Commission's Directorate-General (DG) for Health and Food Safety advised me of that interpretation regarding the MDR.  For the UK, end users don't generally meet the UK regulations' trigger for "supply" or placing on the market.  If instead the end user places the devices on the market or makes them further available on the market, then UK MDR regulatory obligations would ensue.  As long as the end user only uses the devices for their own particular end use, then they aren't supplying or placing the devices on the market.  Note that end users can however trigger certain requirements regarding custom-made devices.

Dear all,

For our UK market we are planning to launch a web shop for one of our products (class IIb implantable, currently MDD approved, but soon MDR approved) as a pilot. The product is intended for professional use. At the moment we are selling our products via an UK distributor (which is also the importer). For this pilot via a web shop, we are going to sell our products directly to hospitals/clinics and end-users. 

How does this work in terms of 'importers' due to the fact all importers should be listed in the UK database. Are end-users considered as importers and is there a difference for MDD products vs MDR products? 
And if end-users and considered as importers, how to manage this in case of selling to multiple end-users? Do we have to include all end-users in the UK database? This seems very impractical, is there a 'common sense  way' to handle this?

Thank you

Dear all,

For our UK market we are planning to launch a web shop for one of our products (class IIb implantable, currently MDD approved, but soon MDR approved) as a pilot. The product is intended for professional use. At the moment we are selling our products via an UK distributor (which is also the importer). For this pilot via a web shop, we are going to sell our products directly to hospitals/clinics and end-users. 

How does this work in terms of 'importers' due to the fact all importers should be listed in the UK database. Are end-users considered as importers and is there a difference for MDD products vs MDR products? 
And if end-users and considered as importers, how to manage this in case of selling to multiple end-users? Do we have to include all end-users in the UK database? This seems very impractical, is there a 'common sense  way' to handle this?

Thank you

Kevin Randall has already mentioned that direct import to end users does not make them into importers and from a regulatory perspective, no importation takes place. Obviously, importation from the perspective of logistics and customs still happens and those requirements must be fully met. 

There is a point that Kevin only touches on and this is about the responsibilities of that end user ordering a device from outside their market: they are taking up responsibities regarding the safety and performance of the device. Sooner or later there will be a case where a hospital finds themselves accused of injuring a patient with a device that should not have been used on the UK market (e.g. counterfeight). What you could do, is to add the role of the regulatory importer. That is a company that is on the label as the importer, although they are not directly involved in the logistics. They add that extra layer of protection against non-compliant devices that is intended by this particular role. 

There are companies offering this service. Reach out if you want to know more about that. 

------------------------------
Ronald Boumans
MDR Expert
Super PRRC
Netherlands

Original Message:
Sent: 24-Jan-2024 05:23
From: Anonymous Member
Subject: UK importer & hospital/clinic end users

This message was posted by a user wishing to remain anonymous

Dear all,

For our UK market we are planning to launch a web shop for one of our products (class IIb implantable, currently MDD approved, but soon MDR approved) as a pilot. The product is intended for professional use. At the moment we are selling our products via an UK distributor (which is also the importer). For this pilot via a web shop, we are going to sell our products directly to hospitals/clinics and end-users. 

How does this work in terms of 'importers' due to the fact all importers should be listed in the UK database. Are end-users considered as importers and is there a difference for MDD products vs MDR products? 
And if end-users and considered as importers, how to manage this in case of selling to multiple end-users? Do we have to include all end-users in the UK database? This seems very impractical, is there a 'common sense  way' to handle this?

Thank you

Dear all,

For our UK market we are planning to launch a web shop for one of our products (class IIb implantable, currently MDD approved, but soon MDR approved) as a pilot. The product is intended for professional use. At the moment we are selling our products via an UK distributor (which is also the importer). For this pilot via a web shop, we are going to sell our products directly to hospitals/clinics and end-users. 

How does this work in terms of 'importers' due to the fact all importers should be listed in the UK database. Are end-users considered as importers and is there a difference for MDD products vs MDR products? 
And if end-users and considered as importers, how to manage this in case of selling to multiple end-users? Do we have to include all end-users in the UK database? This seems very impractical, is there a 'common sense  way' to handle this?

Thank you

Dear all,

For our UK market we are planning to launch a web shop for one of our products (class IIb implantable, currently MDD approved, but soon MDR approved) as a pilot. The product is intended for professional use. At the moment we are selling our products via an UK distributor (which is also the importer). For this pilot via a web shop, we are going to sell our products directly to hospitals/clinics and end-users. 

How does this work in terms of 'importers' due to the fact all importers should be listed in the UK database. Are end-users considered as importers and is there a difference for MDD products vs MDR products? 
And if end-users and considered as importers, how to manage this in case of selling to multiple end-users? Do we have to include all end-users in the UK database? This seems very impractical, is there a 'common sense  way' to handle this?

Thank you

Hi Anon,

as an additional thought: Talk to your UK responsible person to see how they would interpret this. Maybe it would even be possible to have them as a pro-forma importer for these devices, so that you have clear responsibilities.

Sometimes the consequences are difficult to assess and you would like to avoid that your customers suddenly have responsibilities they did not realize, even if they might not considered to be importers (e.g. in Switzerland direct import and use of medical devices under certain circumstances might lead to a health institution being fully responsible for the conformity of the device without them being an importer, see here).

Best regards, Christoph

Dear all,

For our UK market we are planning to launch a web shop for one of our products (class IIb implantable, currently MDD approved, but soon MDR approved) as a pilot. The product is intended for professional use. At the moment we are selling our products via an UK distributor (which is also the importer). For this pilot via a web shop, we are going to sell our products directly to hospitals/clinics and end-users. 

How does this work in terms of 'importers' due to the fact all importers should be listed in the UK database. Are end-users considered as importers and is there a difference for MDD products vs MDR products? 
And if end-users and considered as importers, how to manage this in case of selling to multiple end-users? Do we have to include all end-users in the UK database? This seems very impractical, is there a 'common sense  way' to handle this?

Thank you

Thank you all for your comments. 

We have contacted our Authorised Representative in the UK and they answered the following:
The MHRA has confirmed that in the case of distance sales, the end user is not considered the importer unless they are placing the device on the market or making it available. Therefore, if there is no importer there is currently no requirement for registration within the UK database. 

Hi Anon,

as an additional thought: Talk to your UK responsible person to see how they would interpret this. Maybe it would even be possible to have them as a pro-forma importer for these devices, so that you have clear responsibilities.

Sometimes the consequences are difficult to assess and you would like to avoid that your customers suddenly have responsibilities they did not realize, even if they might not considered to be importers (e.g. in Switzerland direct import and use of medical devices under certain circumstances might lead to a health institution being fully responsible for the conformity of the device without them being an importer, see here).

Best regards, Christoph

Dear all,

For our UK market we are planning to launch a web shop for one of our products (class IIb implantable, currently MDD approved, but soon MDR approved) as a pilot. The product is intended for professional use. At the moment we are selling our products via an UK distributor (which is also the importer). For this pilot via a web shop, we are going to sell our products directly to hospitals/clinics and end-users. 

How does this work in terms of 'importers' due to the fact all importers should be listed in the UK database. Are end-users considered as importers and is there a difference for MDD products vs MDR products? 
And if end-users and considered as importers, how to manage this in case of selling to multiple end-users? Do we have to include all end-users in the UK database? This seems very impractical, is there a 'common sense  way' to handle this?

Thank you