EU authorised representative
Your regulatory presence in the European Union
If your medical device or IVD company is established outside the EU, you need an authorised representative. MDRC becomes your official point of contact in the Union and helps you maintain access to the European market.
Why it matters
More than an address on the label
An authorised representative acts under a written mandate and performs specific MDR or IVDR tasks on the manufacturer's behalf. The representative is part of the regulatory chain and has legal responsibilities of its own.
A condition of market access
A manufacturer established outside the EU must appoint a single authorised representative before placing its device on the Union market.
An official contact in the EU
Competent authorities and other market actors have an accessible EU-based party that understands the product and can support timely communication.
A lifecycle relationship
Representation continues after registration and covers documentation, authority requests, complaints, incidents and corrective action.
The right representative
Your representative should understand your product, not only the rules
An authority request, incident or documentation change calls for more than forwarding a message. Your representative must recognise the regulatory significance, understand how the issue connects to the technical documentation and help you provide a coherent response.
We work as part of your regulatory team while preserving the independence required to fulfil the mandate responsibly.
A contact exists, but the manufacturer is left alone with the regulatory substance of the question.
We assess the context, connect the question to the compliance system and help move the matter towards resolution.
What we take care of
One responsible point of contact in the EU
The mandate defines the tasks required by law. Our work centres on four practical areas that support the continuity of your presence on the European market.
Appointment and registration
We establish the mandate, check the required information and support registration of the manufacturer and representative in the applicable European system.
Documentation and compliance
We verify that the declaration of conformity, technical documentation and relevant certificates are available and keep them accessible to competent authorities.
Communication with authorities
We receive requests, maintain clear communication and cooperate with competent authorities on compliance matters and corrective action.
Post-market signals
We forward complaints and reports of suspected incidents to the manufacturer and support a timely regulatory response.
How we begin
A straightforward transition to MDRC representation
We first understand your product and its current regulatory status. We then agree the mandate, necessary actions and working arrangements so communication is fast and predictable from the moment of appointment.
After appointmentWe stay involved through product changes, documentation updates, authority requests and post-market events.
Work with MDRC
Enter the EU market with a representative who understands your technology
Tell us about your product, current conformity status and intended markets. We will identify what is needed to appoint MDRC as your authorised representative and establish an effective working relationship.
Discuss representation
