EU AUTHORIZED REPRESENTATIVE · MDR
Your EU market entry,
with a local partner.
Maxelbeauty supports medical device manufacturers based outside the
European Union with Authorized Representative services under the EU
Medical Device Regulation (MDR).
For non-EU manufacturers · MDR medical devices
For manufacturers outside the EU
Preparing to place a medical device on the European market ? Start with a clear
conversation about your device, documentation, and representation needs.
THE ROLE
A defined role. A clear point of contact.
An EU Authorized Representative is appointed by a manufacturer established outside the EU through a written mandate. The representative carries out the tasks agreed in that mandate and the responsibilities set out in the MDR.
Maxelbeauty is registered in EUDAMED as an Authorized Representative. We discuss the device and proposed mandate before confirming whether we can act for a manufacturer.
MAXELBEAUTY
Our representative role
Act within the accepted mandate, maintain access to specified compliance documents, and support relevant communication with EU competent authorities.
MANUFACTURER
Your manufacturer responsibilities
The manufacturer remains responsible for device conformity, technical documentation, quality management, and other obligations that remain
with the manufacturer under the MDR.
HOW WE CAN SUPPORT
Support through the representation process
We agree the exact scope together, based on your device, documentation, and requested mandate.
01
Mandate
& scope
Discuss the device group, responsibilities, documentation access, and proposed mandate.
04
Authority
interface
Provide an EU point of contact and coordinate responses to competent authorities within the agreed scope.
02
Documentation coordination
Coordinate access to the documents specified in the mandate for competent authority requests.
05
Post -market communication
Coordinate relevant safety, vigilance, and corrective -action communications under the mandate.
03
EUDAMED coordination
Support relevant actor registration steps and
coordinate the mandate information required for
registration.
06
Ongoing representation
Maintain the agreed representation relationship
and review changes that may affect its scope.
GETTIN G STARTED
A practical path to representation
01
Tell us about the device
Share its intended purpose, current regulatory status, and your EU plans.
02
Initial fit review
We discuss the device and confirm
whether it fits our service scope.
03
Review the mandate
Agree responsibilities, documentation access, and the representation scope.
04
Coordinate registration
Work through the applicable actor -registration steps and required information.
05
Ongoing relationshp
Maintain the agreed contact, document access, and communications.
BEFORE WE BEGIN
What to prepare for an initial discussion
A first conversation is more useful when we understand your device and current MDR position.
-
Device description and intended purpose
-
Device classification and rationale, if available
-
Current conformity assessment and CE-marking status
-
Availability of technical documentation and EU Declaration of Conformity
-
Your target markets and launch timeline
COMMON Q UESTIONS
Good to know
Does an Authorized Representative appointment
certify my device?
No. Appointment does not certify or approve a device. The manufacturer remains responsible for conformity assessment and applicable MDR requirements.
Can Maxelbeauty represent every MDR device?
We review each device and proposed mandate before confirming whether it falls within our servicescope.
Does this service cover IVD products?
This page covers medical devices under the MDR and in vitro diagnostic devices (IVDs) under the IVDR. Maxelbeauty is registered in EUDAMED in Belgium as an EU Authorised Representative and accepts mandates under both regulations, subject to review of each device and the agreed scope.
Planning to enter the EU market ?
MAXELBEAUTY
Regulatory expertise. Medical technology. Professional support.