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MDR Importer/Distributor Definition Questions

Ed Panek

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#11
#11
(27) ‘making available on the market’ means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
(33) ‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market; (34) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;

Are you including a Declaration of Conformity with the product?



Article 16
Cases in which obligations of manufacturers apply to importers, distributors or other persons

1.A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:

(a) makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;

(b) changes the intended purpose of a device already placed on the market or put into service;

(c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.

The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.
 
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U

UNIJP

Starting to get Involved
#12
#12
fayetheforcebewithyou said:
Hello,

I also have a similar question.
My company sells devices directly to doctors in their own offices in the EU (not hospitals). We have come to believe that the doctor is the end user of the device. The doctor does not further distribute the device. Is the doctor an importer? Does the doctor need to register in Eudamed as an importer?
Is defining an importer role required if we sell directly to end users?

Thank you.
Click to expand...
I guess article 6 "Distance sales" applies.
 
P

Philip B

Involved In Discussions
#13
#13
I attended a webinar recently that stated that if you sell direct to an end user in the EU and they accept the transaction, they become the importer by default and take on the regulatory responsibilities of the importer. Your doctors are probably unaware of this and wouldn't want the responsibility. We are setting up a registered office in the EU to act as the importer, as far as I can ascertain, you can be your own importer.
 
C

ChrystalAnne

Registered
#14
#14
Philip B said:
I attended a webinar recently that stated that if you sell direct to an end user in the EU and they accept the transaction, they become the importer by default and take on the regulatory responsibilities of the importer. Your doctors are probably unaware of this and wouldn't want the responsibility. We are setting up a registered office in the EU to act as the importer, as far as I can ascertain, you can be your own importer.
Click to expand...
Do you remember what webinar you attended that stated that if you sell direct to an end user in the EU and they accept the transaction, they become the importer by default?
 
N

nozzle

Involved In Discussions
#16
#16
Hi all,
Does the MDR Importer requirement cover all devices when the MDR comes into force on 26th May?
Our importer is now telling us these requirements cover all devices regardless of them being registered under the MDD or MDR. My understanding was our Class IIa devices would not require an importer under the scope of our MDD certificate which expires in September 2023.
 
P

Philip B

Involved In Discussions
#17
#17
My best understanding is yes, the MDR importer requirements are effective from 26th May, irrespective of whether you are under the MDD or MDR. Hard to find a definitive answer on this though which is frustrating. We are working towards meeting 26th May in case.
 
P

Philip B

Involved In Discussions
#19
#19
Yes we are. We're setting up a registered office in Germany and they will have access to me as PRRC. There doesn't seem to be anything to prohibit this and it is the most cost-effective solution for us.
 
N

ncase

Registered
#20
#20
Philip B said:
Yes we are. We're setting up a registered office in Germany and they will have access to me as PRRC. There doesn't seem to be anything to prohibit this and it is the most cost-effective solution for us.
Click to expand...
In your case, is it a full-time staffed office and are you shipping products to that office, or is it just a minimally staffed office just to cover the legal EU importer requirements.
 
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