How to start
How to appoint an EU Authorised Representative for Class I medical devices
Getting started is straightforward. We first check whether your company and products fall within the scope of this service.
- Confirm that your products are Class I and share your company details
- Sign the EU Authorised Representative contract
- Provide your CE Declaration of Conformity and technical documentation
- Check your labelling, CE marking and medical device marking
- Link your company to the EU Authorised Representative
- Create the required Basic UDI-DI information for your products in EUDAMED
After the documentation and EUDAMED steps are confirmed, we can act as your EU Authorised Representative for the accepted Class I medical devices.
EU Authorised Representative services: What You Get and What You Need
Placing a Class I medical device on the EU market requires more than appointing a contact address.
Your company must be registered correctly, your documents must be available and your product information must match the MDR requirements.
Below you can see what is included in the service and what you need to prepare.
What happens after I sign up?
We first check whether your product is a Class I medical device, whether your company is based outside the EU and whether you are the manufacturer. If the product fits our scope, we send the EU Authorised Representative contract for signing.
What is included in the service?
The service includes EU Authorised Representative appointment, proof of representation, document storage, authority contact and support with linking your manufacturer registration in EUDAMED.
What do I need to prepare?
You need a valid CE Declaration of Conformity, correct labelling, technical documentation, product information, user manuals where applicable and company details. Your label should include the required CE marking and medical device information.
What needs to happen in EUDAMED?
You need to apply as manufacturer in EUDAMED, link your company to the EU Authorised Representative and create the required Basic UDI-DI information for your products. After this is confirmed, the EU REP relationship can be completed.
Ready to get started? You can set up your EU Responsible Person within minutes.
Why do I need an EU Authorised Representative?
You need an EU Authorised Representative if you are a manufacturer based outside the European Union and you want to place Class I medical devices on the EU market.
You are located outside the EU
If your company is located outside the EU, you cannot act as your own EU Authorised Representative.
A representative established in the European Union must be appointed before the accepted devices are placed on the EU market.
You are the manufacturer
This service is for manufacturers of Class I medical devices.
You are considered the manufacturer if the device is placed on the market under your name or brand and you are responsible for the design, production, packaging, labelling or intended purpose of the product.
You sell Class I medical devices
This service only applies to Class I medical devices under the EU MDR.
Class I devices are generally lower-risk medical devices, but they still require CE marking, a valid Declaration of Conformity, technical documentation and correct labelling.
You sell through distributors, marketplaces or your own website
Whether you sell through a distributor, importer, online marketplace, healthcare supplier or your own website, your MDR obligations still apply.
Your EU Authorised Representative details may be requested before your products are accepted for sale in the European Union.
Products
Which products are covered?
This service is only for Class I medical devices that can be self-certified by the manufacturer under the EU MDR.
If you are not sure whether your device is Class I, we can review the product category before starting the appointment process.
These products are covered
This service is only for Class I medical devices that can be self-certified by the manufacturer under the EU MDR.
Examples may include:
Certain non-invasive medical devices
Some first aid and healthcare products
Some mobility and rehabilitation products
Certain examination or monitoring accessories
Products correctly classified as Class I under the MDR
These products are not covered
This service does not cover medical devices that require a Notified Body or fall outside our Class I scope.
We do not cover:
Class III medical devices
Implantable devices
Sterile Class I devices
Class I devices with a measuring function
Reusable surgical instruments
In vitro diagnostic medical devices
Products without a valid CE Declaration of Conformity
Products with incomplete technical documentation
Products incorrectly presented as medical devices
Frequently Asked Questions
Here are some common questions about this service.
Yes. If the manufacturer is based outside the EU, Class I medical devices need an EU Authorised Representative before they are placed on the EU market.
No. This service is only available for Class I medical devices. We do not cover Class IIa, Class IIb, Class III, implantable devices, sterile Class I devices, measuring devices or reusable surgical instruments.
Most Class I medical devices can be self-certified by the manufacturer. However, some Class I devices, such as sterile devices, devices with a measuring function or reusable surgical instruments, require Notified Body involvement and are not covered by this service.
You usually need a valid Declaration of Conformity, technical documentation, product label, user manual where applicable, risk management documentation and evidence supporting the intended purpose and claims.
Yes. As a non-EU manufacturer, you need to apply as manufacturer in EUDAMED and link your registration to the EU Authorised Representative.
A Basic UDI-DI is the main device identifier used to group and register medical devices in EUDAMED. The manufacturer is responsible for creating the Basic UDI-DI information for the products.
Yes, but UK manufacturers are treated as non-EU manufacturers for EU MDR purposes. They need an EU Authorised Representative before placing Class I medical devices on the EU market.
The EU Authorised Representative is appointed by the non-EU manufacturer to act as the official EU representative. The importer is the party that places the device from outside the EU onto the EU market and has its own obligations.
Yes, once your product is accepted and the appointment is confirmed, the EU Authorised Representative details can be used where required for the accepted Class I medical devices.
If your documentation is incomplete, the appointment cannot be fully confirmed for that product. You will need to update the Declaration of Conformity, technical file, label or other required documents before proceeding.
Still not sure?
Plan a free call with one of our consultants
and ask anything you want.
News
Our latest content
Check out our latest blog posts.
Reviews
Customer testimonials
What our customers are saying about us.
"Trying to wrap my head around GSPR and Joe made it super easy to do and understand."
Leanne
Botanical arts seller
United Kingdom
"Joe has been unbelievably helpful to keeping me up to date with ALL GPSR related compliance and questions, essential for business."
Jesse
Vinyl records seller
United States
"Very helpful in my hour of Amazon frustrations!!"
Martin
Amazon seller
"Joe and Youri are amazing. They walked me through the complex world of GPSR and CE compliance and made the process easy. Couldn't have done it without them. Highly, highly recommended."
Eugene
Wheelchair glove seller
Lithuania
"I would recommend his services to anyone looking to start selling in the EU again with the GPSR regulations in place."
Amanreet
Board game seller
"Joe is very accommodating & works with you to find solutions."
Hasan
Plastics manufacturer
Canada
Our references
We have worked together with a wide arrange of customers from all over the world.
Let's Connect
Have a question or need assistance? Share your details below and we’ll get back to you with the support you need.
Company details
We'd love to hear from you! If you have any questions, feedback, or need assistance, please feel free to reach out to us using the contact details provided. Our team is here to help and will respond as soon as possible. Thank you for getting in touch!
Phone
Office
Fellenoordstraat 52 Unit 2.38, 4811TJ Breda, Netherlands
VAT
NL865927534B01
Chamber of Commerce
NL 92195873