Non-EU Medical Device Manufacturer need a European Authorized Representative with an agreement to sell product in Europe. Learn Roles and Responsibilities and how to choose one. Free checklist available and list of existing Authorized Representative. Why you should not choose your distributor as a EC REP

1. European Authorized
Representative
A guide by Monir El Azzouzi

2. Definition of a European Authorized
Representative?

3. MDR 2017/745
‘Authorized Representative’ means
any natural or legal person established
within the Union who has received and
accepted a written mandate from a
manufacturer, located outside the
Union, to act on the manufacturer's
behalf in relation to specified tasks
with regard to the latter's obligations
under this Regulation;
Tip
On the regulation, an
Authorized
Representative, importer
and distributor are also
called ‘Economic
Operator’

4. Instead of ‘Economic Operator’ I
would say ‘Economic Partner’ as
they should be really
supporting you.
Tip
Without an Authorized
Representative it’s not
possible to make
business in Europe.

5. Who needs a European Authorized Representative

6. Mandatory
If you are:
➔ Located outside EU
Companies outside EU can be out of
EU law as they have no place of
business there.
➔ Want to sell Medical Devices
To receive authorization to sell your
Medical Devices in EU you have to
appoint one. It will be mandatory to get
your CE certification from the Notified
Body.

7. How to become an Authorized Representative

8. First!
You should be a natural or legal person established in the European Economic
Area (EEA, including EU & EFTA)
Second!
You should be appointed by a non-EU manufacturer
Tip
If you are interested by
being an Authorized
Representative, you
need to really
understand the Roles
and Responsibility of
this function

9. Roles and Responsibility of an Authorized
Representative

10. Minimum requirements
● Verify the Declaration of Conformity
● Review the Technical Documentation
● Check where applicable that an appropriate conformity assessment exist
● Keep the previous documentation (Declaration of conformity, Technical
Documentation, certificates issued by Notified Body and amendments) at
the disposal of competent authorities (at least 10 years and for
implantable devices it's 15 years)
● Verify that the manufacturer is complying with the registration of the
Unique Device Identification according to article 27
WAIT IT’S NOT FINISHED

11. Follow-up: Minimum requirements
● Make sure that the registration of the device is performed according to
article 29
● Also that the registration of the manufacturer, Authorized Representative
and importers are done according to article 31
● In case requested by the competent authorities, the Authorized
Representative should give all the information and documentation
necessary to prove the conformity of a device, in an official language
● Keep the manufacturer informed of any request coming from the
competent authorities.
● Verify that the competent authorities receives the samples or is given
access to the device

12. Follow-up 2: Minimum requirements
● Immediately tell the manufacturer about complaints and reports from
healthcare professionals, patients and users related to suspected
incidents performed by their device.
● Terminate the mandate if the manufacturer acts contrary to its
obligations under this Regulation
OK! Now we are done
And this is only the minimum

13. Be careful!
If the manufacturer provide to the European Union Fraudulent products, the
Authorized Representative can be legally liable for defective device on the
same level as the manufacturer
Administrative tasks!
The manufacturer can ask you to execute some tasks.
These are related to the national laws of the member states
Tip
Your agreement will be
your best place to write
exactly what are the
roles and responsibility
of each of the parties.

14. What if I don’t appoint an Authorized
Representative?

15. Bad idea
As it’s mandatory, you will be in trouble if you
don’t do it.
➔ EC Certificate
The Notified Body will not issue a EC
certificate if you have not Authorized
Representative
➔ Border
Your product will be blocked at the
border as there is no Marketing
Authorization issued by the Competent
Authorities.

16. Where does your Authorized Representative name
appear

17. Behind this
The Authorized Representative Name,
Address and Contact detail should be
written behind this logo.
This should be on the labeling material
and can be on the marketing material

18. Audit of my Authorized Representative

19. Yes, it’s possible

20. What should he provide
Upon request, the Competent Authorities can ask your Authorized
Representative to provide:
- Technical Documentation
- Information on Field Actions
- Declaration of conformities
All this should be available at its Headquarter

21. Can I change my Authorized Representative

22. Article 13 says yes
For sure you can change your
partner but I hope you have a solid
reason for that as this will not be
simple.
Article 13 of the Medical Device
Regulation provides the
requirements.
Tip
If you want to continue
make business in EU,
you then have to find
quickly a new one to
represent you before
you can withdraw your
agreement.

23. Compliance
To be compliant, the manufacturer should address the following aspects:
● The date of termination of the outgoing Authorized Representative and the date of
start of the incoming one.
● The date until which the manufacturer can show the outgoing one on the
information or promotional material
● The transfer of documents, including confidentiality aspects and property rights
● The obligation to the outgoing Authorized Representative to send to the
manufacturer or incoming Authorized Representative, any complaints or reports
from healthcare professionals and patients or users about suspected incidents
related to the device for which it has been designated.

24. It will be a really
expensive project
Are you
sure you
want to
do that?

25. Change of
labeling

26. Change of labeling
Imagine now!
You’ll have to change all your labeling (Packaging, IFU, labels and marketing
material)
You’ll need to inform the Notified Body to change the certificates
You’ll need to find a new one

27. Choose your Authorized
Representative Right the First
time!

28. HOW?

29. Method
I prepared a some points to be successful
➔ Don’t choose your Distributor
There is a conflict of interest
➔ Don’t choose one in the UK
By May 2019, UK will not be anymore in
the EU. Same situation if your notified
body is in UK.
➔ Follow the 5 steps
On my Article “11 Questions about EC
Authorized Representative” I describe
my best method to select the right one

30. Check my article
11 Questions about EC
Authorized
Representative
(Medical Device)
Source: easymedicaldevice.com
Tip
I added a checklist and a
list of European
Authorized
Representative

31. Good luck!
I hope this will help you to understand the
roles and responsibility of an Authorized
Representative
For more article on Medical Devices, visit my
website
easymedicaldevice.com
My Name is Monir El Azzouzi - I am an expert
on Medical Devices in the area of Quality and
Regulatory Affaires.