Home
Services ﹀
Clinical evaluation EU Authorized representative Notified bodies Post-market surveillance PRRC Quality management system Risk management Technical documentation
Devices﹀
General devices and equipment In vitro diagnostics Medical software
Articles About Contact us

Send us an email:
info@mdrc-services.com

Or use the contact form below

 
Technical documentation EU Authorized representative Clinical evaluation PRRC services Risk management Notified bodies Quality management system Post-market surveillance
General medical devices and equipment In vitro diagnostics (IVD) Medical Device Software (MDSW)
CE-marking process for medical devices CE-marking process for in vitro diagnostics MDR technical documentation checklist IVDR technical documentation checklist Technical documentation checklist for MDSW PRRC under MDR or IVDR
CE-Certificate vs. EC-Certificate Basic UDI-DI (bUDI) EUDAMED registration - a brief guide Read more >>

Your authorised representative in the European Union


According to the Medical Device Regulation and In Vitro Diagnostic Medical Device Regulation, non-EU manufacturers who place their devices on the European market are required to designate an Authorised Representative in the European Union.



Are you looking for an Authorised Representative in the EU?

Partnering with us as your Authorised Representative means having a reliable and knowledgeable ally by your side.

Contact us right now

EC REP responsibilities

The term "European Authorised Representative" refers to a natural or legal person located within the European Union who has been granted a written mandate by a non-EU manufacturer. This mandate empowers them to act on behalf of the manufacturer in carrying out specified tasks in accordance with the MDR or IVDR.

MDR and IVDR outline the delegated tasks and conditions for the manufacturer's authorised representative. A clear and precise mandate between the EC REP and the manufacturer should cover this relationship. The authorised representative carries out the tasks specified in the mandate and must provide a copy to the competent authority upon request.

The Authorised Representative assumes joint liability with the manufacturer for any issues pertaining to defective medical devices. This includes taking responsibility for cases of noncompliance or incompliance on the part of the manufacturer.

EC REP responsibilities

The term "European Authorised Representative" refers to a natural or legal person located within the European Union who has been granted a written mandate by a non-EU manufacturer. This mandate empowers them to act on behalf of the manufacturer in carrying out specified tasks in accordance with the Medical Device Regulation (MDR) or In Vitro Diagnostic Medical Device Regulation (IVDR). Authorised Representatives play a crucial role in ensuring device compliance and serve as the primary point of contact for European authorities and Notified Bodies. Their involvement is instrumental in upholding regulatory requirements and facilitating smooth communication between manufacturers and regulatory entities within the European Union.

MDR and IVDR outline the delegated tasks and conditions for the manufacturer's authorised representative. A clear and precise mandate between the EC REP and the manufacturer should cover this relationship. The authorised representative carries out the tasks specified in the mandate and must provide a copy to the competent authority upon request.

The Authorised Representative assumes joint liability with the manufacturer for any issues pertaining to defective medical devices. This includes taking responsibility for cases of noncompliance or incompliance on the part of the manufacturer.

Authorised Representative's tasks under MDR and IVDR

As your Authorised Representative we ensure a successful market presence for your MD or IVD products in the European Union.

Send us an email:
info@mdrc-services.com

Or use the contact form below