Economic Operator based in UK

#1
Hi all, apologies if this has been done to death but can anyone offer any clarification on a business based in the UK acting as an Importer of a medical device from a third country?

The definition of an Importer in the MDR states: "importer" means any natural or legal person established within the Union that places a device from a third country on the Union Market: "

Now that the UK has left the Union and is considered a third country for MDR, is it possible for us to still act as an importer? What is the role if we buy from a third country and sell back into the EU; USA to UK to Germany for example? I literally can't find a thing that clearly explains or clarifies the Importer role when buying third country to third country and then exporting back in to the EU! I know this wouldn't be an issue if we were only supplying the purchased goods within the UK but we export back into the EU so the goods we buy must be MDR compliant and our role defined as if we are/can be classed as an importer am I right in thinking we then need an EU Authorised Rep and Eudamed registration? Anyone have any experience of this or have any useful links/contacts for advisors?
 
Elsmar Forum Sponsor

Awadine

Starting to get Involved
#2
As I understand it you are a UK Importer but can not be the EU Importer. In the example you gave (UK to Germany) then the German entity would probably be the importer. As the definition states, the EU importer must be established in the EU.

An authorised rep in the EU will be required if the manufacturer is based in a Third Country and yes, the manufacturer, authorised rep and importer will all need to be registered in Eudamed.
 
#3
Thanks so much, you wouldn't know how selling to an end user in the EU would work would you? The end user would not necessarily be the Importer in that instance as we would be selling to many customers.

We have a distributor agreement with a manufacturer in a third country, we would be their UK importer with permissions to export into the EU...this is the part I'm really struggling with. The manufacturer has already registered with Eudamed via their EU Authorised Rep and they have a UK Rep in place, does this satisfy all of the requirements or would there still have to be a registered "Importer" to receive the goods into the EU? If we are the Importer for the UK, I'm just a little unsure as to what our responsibilities are for exporting the product to place it on the EU market...
 

Awadine

Starting to get Involved
#4
Hi

From the information provided, it looks like you will be distance selling into the EU then, if you sell direct to a customer from the UK with no EU entity involved.

I am not sure how that would work. Does the manufacturer have an EU importer?

Hopefully someone who knows more about distance selling will be along shortly with some good advice .
 
#5
Thanks for taking the time to provide this info :)

I don't think the manufacturer does have an EU Importer as we have always been their distributor into the EU, its just that MDR (and Brexit!) has changed all of this - I'm hoping someone can give me definitive advice or recommend an advisory company on selling the devices into the EU from the UK as we will have the responsibility to ensure they are MDR compliant. I'm clear on the responsibilities that come with each EO status, I'm just really unclear on whether or not we are classed as placing the device on the Union market if we are as you mention distance selling to an end user.
 

Raisin picker

Involved In Discussions
#6
I Think MDR is here quite clear: Article 2 (33):
‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;
You are based in UK, you cannot be importer. You need someone based in EU for the role of importer.
 
#7
Thanks, this is my understanding of the MDR however a colleague has raised that we can act as an Importer?! I'm thinking we might be more going down the line as being UK Importer and a distance seller now that I have looked into this thanks to the poster above, we sell to end users and so I think Article 6 is applicable to us.
 
Last edited:
Thread starter Similar threads Forum Replies Date
H EU MDR Economic Operator notifications? EU Medical Device Regulations 1
P Economic operator responsibilities - when the Importer is also Distributor - Article 13 EU Medical Device Regulations 1
M Informational EU – M2M Data Exchange available services for accessing MDR EUDAMED data available for Economic Operator (EO) organisations Medical Device and FDA Regulations and Standards News 0
K Article 23 (Parts and components) - Economic Operator EU Medical Device Regulations 1
somashekar Adding an other process into the system - Authorised Economic Operator (AEO) Scheme ISO 13485:2016 - Medical Device Quality Management Systems 4
C Authorised Economic Operator Status (EU) - HMRC (Her Majesty's Revenue and Customs) Other ISO and International Standards and European Regulations 6
D Economic Operators, EU Market Access EU Medical Device Regulations 2
Z Economic Operators Responsibilities after DOA for legacy MDD devices EU Medical Device Regulations 2
Z Role of economic operators (EO) post the EU MDR Date of application in May 2020 EU Medical Device Regulations 1
N "Beyond Economic Repair" - Scrapping Customer Material - DCMA Quality Manager and Management Related Issues 7
M Setup Time vs. Economic Run Quantity Manufacturing and Related Processes 1
Sidney Vianna New Collection of International Case Studies proves Economic Benefits of Standards Other ISO and International Standards and European Regulations 1
bobdoering Myth or Mythunderstanding: Implications of the Economic Design of Control Charts Statistical Analysis Tools, Techniques and SPC 1
Marc How Uncle Sam fashioned Television's Economic Model in the US World News 4
AnaMariaVR2 Effects of the Economic Downturn in Quality Systems & Quality in General Career and Occupation Discussions 9
S EOQ (Economic Order Quantity) - Use for managing Customer Orders - asking help Lean in Manufacturing and Service Industries 5
J ISO 10014 - Realising financial & economic benefits ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Financial & Economic Benefits of a Quality Management System Misc. Quality Assurance and Business Systems Related Topics 2
T Is the Current Economic Climate affecting your Company? Coffee Break and Water Cooler Discussions 17
A During tough economic times, does 'ISO' really help Coffee Break and Water Cooler Discussions 27
J EOQ (Economic Order Quantities) - Solution For Parts Manufacturing Nightmare? Lean in Manufacturing and Service Industries 6
A Economic Order Quantity - Implementing Kanban Supplier Quality Assurance and other Supplier Issues 8
J ISO 10014:2006 - Realizing financial and economic benefits - What is your view? Other ISO and International Standards and European Regulations 4
D Ideas to promote ASQ's Economic Case for Quality (ECQ)? ASQ - American Society for Quality 27
A Linking ISO 9000 to Economic Value Added ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B How to test operator to see if they can catch the defective parts? Manufacturing and Related Processes 8
Melissa CAR is not good enough! Operator Error! ISO 13485:2016 - Medical Device Quality Management Systems 48
Nihls When the MSA results show no operator influence Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
M Nonconforming parts accepted by operator with intention Human Factors and Ergonomics in Engineering 33
M Inter-operator Variability Testing - Requirements for EU Medical Device Regulations 5
B Operator protection - When to apply table 7, Dielectric strength test voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
P How far an operator can reach into a machine before it becomes an ergonomic problem CE Marking (Conformité Européene) / CB Scheme 5
F Operator Manual and Type B Uncertainty Measurement Uncertainty (MU) 3
R Operator's manuals as prevention design control FMEA and Control Plans 2
G 3 Operator Std. Dev. and uncertainty calculation Measurement Uncertainty (MU) 2
T Root causes - operator's actions Problem Solving, Root Cause Fault and Failure Analysis 17
shrutisancheti EU User manual / operator manual / service manual guidance document(s) CE Marking (Conformité Européene) / CB Scheme 2
GoSpeedRacer How to handle operator involvement in the non conformance ISO 13485:2016 - Medical Device Quality Management Systems 5
Fender1 Operator process buy-in - how to get it? Manufacturing and Related Processes 6
K Operator Checks - How to show that they were completed on a checklist as acceptable IATF 16949 - Automotive Quality Systems Standard 2
C ISO 9001:2015 - Non Applicable Design and Development (Power Plant Operator) Design and Development of Products and Processes 2
A Failure Mode from Operator "Components Fallen but Loaded" FMEA and Control Plans 3
A 21CFR807.25 (d) Owner-Operator Contact question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
U USB Connector Operator Protection (MOPP) IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
L Warning Letter adressed to owner/operator or facility? US Food and Drug Administration (FDA) 1
B How to change the FDA Device Registration and Listing Module - Owner/Operator Other US Medical Device Regulations 10
M Template for Quality Awareness Training to all Operator Document Control Systems, Procedures, Forms and Templates 6
P Countermeasure For CMM Operator Error Problem Solving, Root Cause Fault and Failure Analysis 4
I Operator Initialling on Paperwork - FDA Good Documentation Practices Other US Medical Device Regulations 11
M Can I continue using IEC60601-1 Ed2 PSU for MOOP (Means Of Operator Protection) IEC 60601 - Medical Electrical Equipment Safety Standards Series 7

Similar threads

Top Bottom