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Common Questions
About UK Importer Services

These are the most common questions asked by our medical device and IVD clients exporting to the United Kingdom. If you do not find the answer you are looking for, please feel free to contact us.

Audits


Compliance


Labeling/IFU/DoC

What is a Generic Device Group (GDG)?


A Generic Device Group means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics




Basic UDI-DI’s are meant for product families and systems (Generic Device Groups), while the Product UDI-DI is for products on a SKU-level. The Basic UDI-DI numbers are only required when your products start falling under the MDR.


Our understanding is that this is not correct. For products that are shipped without IFU, our preference would be to have e.g. a sticker on the packaging of each product. For now it would also be acceptable to mention MedEnvoy on the shipping slip for these products.





Legacy Devices


Registration

What is the difference between a Basic UDI-DI and a Product UDI-DI?


Basic UDI-DI’s are meant for product families and systems (Generic Device Groups), while the Product UDI-DI is for products on a SKU-level. The Basic UDI-DI numbers are only required when your products start falling under the MDR.





Representation

Do I need an importer (in the UK) when, as an EU manufacturer, I deploy my software medical devices via download from my website?


The expectation is that MHRA will apply similar requirements to economic operators as currently exist in the EU for the importer and distributor. This would imply that you will need an importer, considering your clients who download your medical device software will not take on the role as Importer. At this time, you will need to appoint a UK Responsible Person who will be responsible for registering you as the Manufacturer and your devices, as well as the importer once the MHRA guidance on importer has been released. (NOTE: We are still awaiting a formal guidance document from the MHRA and what is expected from the UK Importer)





Shipping/Customs

Can we keep shipping to the UK with MedEnvoy as our importer even though our submitted request for an UK registration number is not yet approved?


Due to the backlog of the MHRA, it is possible for our customers to ship to the UK if they can show us that they have applied for registration before 1 September 2021.




What if we ship to the UK and then export onward to mainland Europe?


In this case you need to have an importer for the Union and you need to comply with all the respective regulations of the MDR





Legal & Liability

We import from a third party manufacturer and are not the legal manufacturer of the device. Is there a requirement for us to notify the UK MHRA as an importer? Or is it the third party's responsibility to inform about their importers to MHRA?


If the product has CE Marking or UKCA Marking and if the Third Party legal manufacturer is outside the UK and has appointed a UK Responsible Person (which should be identified on the label) and appointed an Importer in the UK and the device and Importer has been registered by the UK Responsible Person with MHRA, then you could import the device but we would recommend you obtain agreement with the Third Party Manufacturer to do so since the Economic Operators in the UK are already in place for the Third Party Manufacturer.

The Third Party Manufacturer could instruct their UK Responsible Person to have them register your company with MHRA as an Importer of their devices.  Or if the Third Party does not have appointed an UK Responsible Person and Importer, you could take on both roles as well and register the device and your company as the UK Responsible Person and Importer (with Third Party Manufacturer approval). Again if the Third Party does have appointed a UK Responsible Person, it will be their responsibility to register your company as the Importer with MHRA.





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